WorldWideScience

Sample records for regulatory authorities pharmaceutical

  1. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

  2. Present and future breast cancer management--bench to bedside and back: a positioning paper of academia, regulatory authorities and pharmaceutical industry.

    Science.gov (United States)

    Bartsch, R; Frings, S; Marty, M; Awada, A; Berghoff, A S; Conte, P; Dickin, S; Enzmann, H; Gnant, M; Hasmann, M; Hendriks, H R; Llombart, A; Massacesi, C; von Minckwitz, G; Penault-Llorca, F; Scaltriti, M; Yarden, Y; Zwierzina, H; Zielinski, C C

    2014-04-01

    Insights into tumour biology of breast cancer have led the path towards the introduction of targeted treatment approaches; still, breast cancer-related mortality remains relatively high. Efforts in the field of basic research revealed new druggable targets which now await validation within the context of clinical trials. Therefore, questions concerning the optimal design of future studies are becoming even more pertinent. Aspects such as the ideal end point, availability of predictive markers to identify the optimal cohort for drug testing, or potential mechanisms of resistance need to be resolved. An expert panel representing the academic community, the pharmaceutical industry, as well as European Regulatory Authorities met in Vienna, Austria, in November 2012, in order to discuss breast cancer biology, identification of novel biological targets and optimal drug development with the aim of treatment individualization. This article summarizes statements and perspectives provided by the meeting participants.

  3. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl

    2014-01-01

    as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n...

  4. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    Directory of Open Access Journals (Sweden)

    Dipak Dilip Gadade

    2016-12-01

    Full Text Available Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

  5. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.

    Science.gov (United States)

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-12-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

  6. Characterization of the evolution of the pharmaceutical regulatory environment.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  7. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

    Ortiz, P.; Mrabit, K.; Miaw, S.

    2000-01-01

    In this lecture the principles of the regulatory authority information system (RAIS) are presented. RAIS is a tool currently being developed by the IAEA for the Regulatory Authorities. It is a part of a set of supporting actions designed to assist member states in achieving the objectives of the Model project on radiation and waste safety infrastructure. RAIS is a tool that provides the management of the Regulatory Authority with the key information needed for the planning and implementation of activities and to ensure confidence that resources are optimally used. The RAIS contains five modules: Inventory of installations and radiation sources; Authorization process; Inspection and follow-up actions; Information on personal dosimetry; Assessment of effectiveness by means of performance indicators

  8. Regulatory authority infrastructure for Namibia

    International Nuclear Information System (INIS)

    Shangula, K.

    2001-01-01

    The Republic of Namibia is participating in the International Atomic Energy Agency's Model Project for the Improvement of National Regulatory Authority Infrastructures in Member States. The paper illustrates our experience in solving problems and difficulties confronted in establishing an effective regulatory authority operating within the existing national infrastructure that should be supported by the Government. An effective regulatory authority is seen as part of the wider administrative scope of our Government through ministerial mandates given by the State from time to time, guaranteeing its independence when implementing legal provisions under statutes. Sections of the report illustrate our experience in the following areas: 1. National radiation protection policy 2. Structure of our national regulatory authority 3. Laws and regulations 4. Provisions for notification, authorization and registration 5. In-depth security measures for radiation sources and radioactive material 6. Systems for the inspection of radiation sources, radioactive materials, enforcement of legal provisions 7. Extent of the applications of radiation sources and radioactive materials in the country. The paper provides information regarding existing Government policy on radiation protection; structure and legal aspects of the national regulatory, including statutes and regulations; the extent of application and uses of radiation sources and security of radioactive materials; human resources: strengths and constraints; management practices and financing of regulatory authority; and plans for emergency recovery of orphan sources. National plans for management of disused sources, recovery of orphan sources, abnormal emergencies, communication of information to affected persons on exposure effects, and the safety training of persons using these applications are discussed. the paper provides a summary and some suggestions of the way forward for Namibia. (author)

  9. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    OpenAIRE

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

  10. Management systems for regulatory authorities

    International Nuclear Information System (INIS)

    Mpandanyama, Rujeko Lynette

    2015-02-01

    For a regulatory body to fulfil its statutory obligations, there is need to develop and implement a regulatory management system that has the necessary arrangements for achieving and maintaining high quality performance in regulating the safety of nuclear and radiation facilities under its authority. Hence, the regulatory management system needs to fully integrate the human resources, processes and physical resources of the organization. This study sought to provide an understanding of the concept, principles, policies and fundamentals of management systems as they relate to regulatory systems in the field of radiation protection and to make appropriate recommendations to ensure that an effective management system exists for the control of ionizing radiation and radiation sources and addresses all relevant stakeholders in Zimbabwe. A comparative analysis was done on the current management status and the ideal management system, which led to the identification of the gaps existing. The main key that was found to be of significance was lack of linkages between processes and management tools within the institution. (au)

  11. Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

    Science.gov (United States)

    Tohkin, Masahiro

    2017-01-01

    I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

  12. Management of the Regulatory Authority Information

    International Nuclear Information System (INIS)

    Suman, H.

    2003-01-01

    Safe Management of the Regulatory Authority Information is one of the essential elements to ensure the effectiveness of the regulatory program as a whole. This paper briefly describes the information management basis in RNRO, which is in charge of the regulatory authority tasks in Syria. SINA-2, a computational tool prepared in RNRO for managing the information related to the inventory of radiation sources and users, is also introduced

  13. Annual Report 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2009-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  14. Annual Report 2007. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2008-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  15. Annual Report 2009. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  16. Annual Report 2010. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  17. Annual Report 2011. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  18. Annual Report 2013. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

  19. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

    ...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

  20. Views from the japanese regulatory authority

    International Nuclear Information System (INIS)

    Aoyama, S.

    2004-01-01

    The legislation system for regulation of radioisotope in Japan was established in 1957. The system has been revised gradually since its establishment. Major amendments of the law were made in 1988 on the basis of ICRP Publication 26 and in 2000 on the basis of Publication 60. Main principles provided in the publication have been already introduced into the law. However, some concepts proposed in the recommendations are still under discussion. The current status of implementation of the ICRP recommendations in the Japanese regulatory system is summarised. Views from the regulatory authority of Japan on the points to be improved in the current system of radiological protection are presented. (author)

  1. Independent regulatory authorities in European electricity market

    DEFF Research Database (Denmark)

    Olsen, Ole Jess; Larsen, Anders; Sørensen, Eva Moll

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16...

  2. Independent regulatory authorities in European electricity markets

    International Nuclear Information System (INIS)

    Larsen, Anders; Pedersen, Lene Holm; Sorensen, Eva Moll; Olsen, Ole Jess

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16 European countries, and discuss the relationship between the organisation of the regulation and the market outcome

  3. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

    Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  4. Technical Memory 2010. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The technical memory 2010 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2010. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

  5. Nuclear Regulatory Authority Act, 2015 (Act 895)

    International Nuclear Information System (INIS)

    2015-04-01

    An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).

  6. Technical Memory 2011. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The technical memory 2011 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2011. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

  7. Technical Memory 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The technical memory 2008 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety, and presented in journals, technical reports, congress or meetings of these specialties by personnel of the mentioned institution during 2008. In this edition the documents are presented on: environmental protection; transport of radioactive materials; regulations; research reactors and nuclear power plants; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; physical dosimetry; knowledge management; radioactive waste management. [es

  8. 76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-04-13

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  9. 76 FR 40412 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... a more limited application by their terms. For more information about the rulebook consolidation...

  10. 75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-29

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

  11. 75 FR 71164 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-11-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  12. 76 FR 12380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-03-07

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1..., the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

  13. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  14. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  15. Services of the Nuclear Regulatory Authority Library

    International Nuclear Information System (INIS)

    Carregado, M.A.; Wallingre, G.V.

    2011-01-01

    Full text; The main of this work is to present the services and activities of the ARN (Autoridad Regulatoria Nuclear) Library to potential users from the biological dosimetry area in the framework of the intercomparison Meeting of the Latin American Biological Dosimetry Network held in Buenos Aires from October 27-30 of 2008. It makes a short chronology of the library; the services offered to each type of users and the tasks related to technical and international cooperation with other organizations such as: the terminology Committee of IRAM (Instituto Argentino de Normalizacion y Certificacion); the input of national literature to the INIS Database of the IAEA; the retrospective digitalisation, indexing and bibliographic description of institutional publications to be submitted to the repository of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations and the participation in nuclear information networks. Finally it shown some relevant data from the internal statistics. (authors)

  16. Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

    Science.gov (United States)

    Johnston, John D; Feldschreiber, Peter

    2014-03-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

  17. 75 FR 21686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-26

    ... to pay arbitration awards to remain in the securities industry presents regulatory risks and is...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or...

  18. 76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-19

    ... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

  19. Independent regulatory authorities - a comparative study of European energy regulators

    International Nuclear Information System (INIS)

    Sander Johansen, K.; Holm Pedersen, L.; Moll Soerensen, E.

    2004-04-01

    Independent regulatory authorities are widely recommended as part of the institutional design of liberalised energy markets - not least by the European Commission. This report describes and compares the regulatory authorities for energy in the EU. Arguments for regulatory independence are presented and discussed, and an index is developed to measure the degree of conformance to theories of regulatory independence. It is established that the main pattern of variation is that countries, which formerly had strong state-owned companies, have chosen to create regulatory authorities at state level with many institutional safeguards for independence. (au)

  20. 78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-09-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule... Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission... or manipulative motivation for the trading activity at issue.\\4\\ Specifically, proposed Supplementary...

  1. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2016

    International Nuclear Information System (INIS)

    2017-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2016 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

  2. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2013

    International Nuclear Information System (INIS)

    2014-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2013 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Building Authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) (12) Abbreviations.

  3. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2015

    International Nuclear Information System (INIS)

    2016-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2015 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

  4. Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies-Why and What?

    OpenAIRE

    Gummerus, Anu; Airaksinen, Marja; Bengtström, Mia; Juppo, Anne

    2016-01-01

    The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs. The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related t...

  5. Cooperation between Norwegian and Russian Regulatory Authorities: NRPA and Rostechnadzor

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The Norwegian Radiation Protection Authority has been cooperating with the Federal Environmental, Industrial and Nuclear Supervision Service, Rostechnadzor, on the upgrading of the regulatory framework for the safe decommissioning and disposal of Radioisotope Thermoelectric Generators. (Author)

  6. 75 FR 59771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...

  7. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-15

    ... registered capacity, may work in other investment-related industries, such as financial planning, or may seek...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule..., 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  8. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-02-10

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  9. 75 FR 2897 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-19

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... hereby given that on December 23, 2009, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). NASD Rule 2450...

  10. 76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  11. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  12. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  13. 76 FR 21084 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2011-04-14

    ... Securities April 8, 2011. I. Introduction On March 3, 2011, the Financial Industry Regulatory Authority, Inc... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64283; File No. SR-FINRA-2011-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer...

  14. 78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2013-10-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer... 5210 (Publication of Transactions and Quotations) October 4, 2013. I. Introduction On August 15, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  15. 76 FR 50796 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-16

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Increase the Position Limit for Options on the Standard and Poor's... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  16. Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

    Science.gov (United States)

    Wang, Hui-Po; Wang, Chun-Li

    2018-04-01

    The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.

  17. Why regulatory indifference towards pharmaceutical pollution of the ...

    African Journals Online (AJOL)

    Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from ...

  18. Sales Growth of New Pharmaceuticals Across the Globe: The Role of Regulatory Regimes

    NARCIS (Netherlands)

    S. Stremersch (Stefan); A. Lemmens (Aurélie)

    2008-01-01

    textabstractPrior marketing literature has overlooked the role of regulatory regimes in explaining international sales growth of new products. This paper addresses this gap in the context of new pharmaceuticals (15 new molecules in 34 countries) and sheds light on the effect regulatory regimes have

  19. Establishing exemption and clearance criteria by the regulatory authority

    International Nuclear Information System (INIS)

    Salih, A.E.A.

    2012-04-01

    This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)

  20. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... characteristics and risks of security futures. \\6\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory Organization's...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement August 27, 2010...

  1. 75 FR 27606 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-17

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry... restated following the formation of FINRA through the consolidation of NASD and the member regulatory...

  2. Risk acceptance criteria of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Felizia, Eduardo R.

    2005-01-01

    This report describes some of the regulatory and control functions legally conferred upon the Argentine Nuclear Regulatory Authority concerning radiological risks, as well as a critical analysis of the radiological risk acceptance criteria contained in the Argentine regulatory system. A summary of the application of regulatory standards AR 3.1.3. - 'Radiological criteria related to accidents in nuclear power reactors' and AR 4.1.3. - 'Radiological criteria related to accidents in research reactors' to concrete cases is made, while the favourable and unfavourable aspects of the risk acceptance criteria are discussed. The conclusion is that the Argentine regulatory system contains adequate radiological risk acceptance criteria, that the latter are consistent with the radiological protection principles applicable to man and that, for the moment, there is no need to perform any modifications that would broaden the conceptual framework on which such criteria are based. (author) [es

  3. Cooperation of Ukrainian regulatory authorities in the SIP

    Energy Technology Data Exchange (ETDEWEB)

    Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

    2003-07-01

    The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

  4. Authority Defied : Need for Cognitive Closure Influences Regulatory Control When Resisting Authority

    NARCIS (Netherlands)

    Damen, Tom G. E.; van Leeuwen, Matthijs L.; Dijksterhuis, Ap; van Baaren, Rick B.

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the

  5. Authority Defied: Need for Cognitive Closure Influences Regulatory Control When Resisting Authority

    NARCIS (Netherlands)

    Damen, T.G.E.; Leeuwen, M.L. van; Dijksterhuis, A.J.; Baaren, R.B. van

    2014-01-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the

  6. Competent authority regulatory control of the transport of radioactive material

    International Nuclear Information System (INIS)

    1987-04-01

    The purpose of this guide is to assist competent authorities in regulating the transport of radioactive materials and to assist users of transport regulations in their interactions with competent authorities. The guide should assist specifically those countries which are establishing their regulatory framework and further assist countries with established procedures to harmonize their application and implementation of the IAEA Regulations. This guide specifically covers various aspects of the competent authority implementation of the IAEA Regulations for the Safe Transport of Radioactive Material. In addition, physical protection and safeguards control of the transport of nuclear materials as well as third party liability aspects are briefly discussed. This is because they have to be taken into account in overall transport regulatory activities, especially when establishing the regulatory framework

  7. Safety culture competition - expectations of a regulatory authority

    International Nuclear Information System (INIS)

    Keil, D.; Gloeckle, W.

    2000-01-01

    The accident at the Chernobyl nuclear power station on April 26, 1986 influenced the development of reactor safety and promulgated two basic concepts especially in Germany. On the one hand, extensive measures of in-plant accident management have greatly reduced the so-called residual risk. On the other hand, a comprehensive safety approach has been initiated which comprises the nuclear power plant as a system together with people, technology, and organization and also includes safety culture. In a modern regulatory concept based on the dynamic development of safety, the authority's classical regulatory function of controlling is supplemented by the objective of promoting safety. While preserving the division of responsibilities between the regulatory authority and plant operators, the authority uses 'constructive critical dialog' as a tool to enhance safety. Besides the regulatory assessment of safety culture on the basis of indications or indicators, also the continuous promotion of safety culture in a dialog with plant operators is seen as one of the duties of a regulatory authority. Continued efforts are necessary to maintain the high level of safety culture in German nuclear power plants. Operators are expected to establish a safety management which assigns top priority to safety issues, and which pursues the goal of supervising and promoting safety culture. Developments on the deregulated electricity markets must not lead to safety aspects ranking second to economic aspects. Moreover, also under changed boundary conditions, only the safe operation of nuclear power plants ensures economic viability. (orig.) [de

  8. The regulatory application of authorization in radiological protection

    International Nuclear Information System (INIS)

    Lazo, T.; Frullani, S.

    2004-01-01

    Authorization is the process used by governments and regulatory authorities to decide what regulatory controls or conditions, if any, should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment appropriately. Over the years, governments and regulatory authorities have used various approaches to the authorization process under differing circumstances. Now, with the new draft recommendations from the International Commission on Radiological Protection (ICRP), there is the prospect of being able to use a single, simple and self-coherent approach for the process of regulatory authorization under all circumstances. Previously, the ICRP recommended the use of various approaches to manage radiological protection situations. For what were called practices, exposures were subject to limits, and optimisation was required below these limits. What were called interventions were subject to intervention levels, above which some action could be considered justified, and which should be optimised based on consideration of how much dose could be averted by the countermeasure considered. Radon in homes was subject to action levels, above which some sort of countermeasure could be recommended. These approaches are all philosophically distinct and logically constructed, but their differences, particularly in the types of numerical criteria used (limits, intervention levels, action levels, etc.) contributed to confusion and misunderstanding. (author)

  9. 77 FR 23770 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-04-20

    ...: The financial markets as a whole should benefit from [limit order display] because the price discovery... revised tier sizes and corresponding liquidity minimum amounts are in the best interest of the market for...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1...

  10. 78 FR 68893 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-11-15

    ... that the size of the BBO equals the minimum quote size. Number of market makers actively quoting...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Tier Size Pilot of FINRA Rule 6433 (Minimum Quotation Size...

  11. 78 FR 69732 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) To Include Information About Members and Their Associated Persons of Any Registered National Securities Exchange That Uses the CRD System for...

  12. 76 FR 67236 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-31

    ... a foreign financial institution, and as part of the corporate control transaction, the foreign... subsidiaries, both of which are U.S. non-broker-dealer financial institutions, and as part of the corporate...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...

  13. 75 FR 29793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-27

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 4, 2010, Financial.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  14. 75 FR 80556 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-12-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 13, 2010, Financial Industry... application by their terms. For more information about the rulebook consolidation process, see Information...

  15. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  16. 77 FR 38694 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-06-28

    ... matrix will be an effective means of assessing related fees. For instance, the proposed fee structure...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Organization's Statement of the Terms of the Substance of the Proposed Rule Change FINRA is proposing to amend...

  17. 76 FR 63969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-14

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1 to Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated... Account Statements) in the Consolidated FINRA Rulebook (``Notice''). The Notice contained incorrect...

  18. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 1999

    International Nuclear Information System (INIS)

    Seliga, M.

    2000-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 1999 is presented. These activities are reported under the headings: (1) Foreword; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of safety at nuclear installations; (4) Safety analyses; (5) Nuclear materials; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Conclusions; (13) Appendices: Economic and personnel data; Abbreviations; The International nuclear event scales - INES

  19. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2000

    International Nuclear Information System (INIS)

    Seliga, M.

    2001-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2000 is presented. These activities are reported under the headings: (1) Foreword and organisation structure; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of nuclear installations; (5) Safety analyses; (6) Nuclear materials and physical protection of nuclear installations; (7) Radioactive waste; (8) Quality assurance; (9) Personnel qualification and training; (10) Emergency preparedness; (11) International co-operation; (12) Public information; (13) Personnel and economic data of the UJD; (14) Conclusion; (15) Attachments: Abbreviations; Radiation safety

  20. The process of regulatory authorization. A report by the CRPPH expert group on the regulatory application of Authorization (EGRA)

    International Nuclear Information System (INIS)

    2006-01-01

    Governments and regulatory authorities are responsible for the definition of regulatory controls or conditions, if any, that should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment. Although countries use different policy and structural approaches to fulfill this responsibility, the recommendations of the International Commission on Radiological Protection (ICRP) are generally used as at least part of the basis for protection. Previously, the ICRP recommended the use of variable approaches to protection. New ICRP recommendations are proposing a single, conceptually simple and self-coherent approach to defining appropriate protection under all circumstances. While the ICRP has been reviewing the broad principles of protection, the NEA Committee on Radiation Protection and Public Health (CRPPH) has been focusing its efforts on how radiological protection could be better implemented by governments and/or regulatory authorities. To this end, the CRPPH has developed a concept that it calls ''the process of regulatory authorization''. It is described in detail in this report, and is intended to help regulatory authorities apply more transparently, coherently and simply the broad recommendations of the ICRP to the real-life business of radiological protection regulation and application. In developing this concept, the CRPPH recognizes the importance of an appropriate level of stakeholder involvement in the process. (author)

  1. Authority defied: need for cognitive closure influences regulatory control when resisting authority.

    Science.gov (United States)

    Damen, Tom G E; van Leeuwen, Matthijs L; Dijksterhuis, Ap; van Baaren, Rick B

    2014-08-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the influence attempt of an authority figure (Study 2; N = 50). Results showed that resisting the influence attempt from a high-authority figure was more depleting for participants higher in NCC compared to individuals lower in NCC. However, when they were given instructions and time to prepare the act of resistance, individuals high in NCC actually showed an increase in regulatory control. Authority is usually viewed as a general principle of influence; however, the present studies suggest that there are individual differences that influence how people may experience interactions with authorities. © 2013 Wiley Periodicals, Inc.

  2. Quality manual. Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    2006-03-01

    This quality manual of the Nuclear Regulatory Authority of the Slovak Republic (UJD) is presented. Basic characteristics of the UJD, Quality manual operative control, and Quality management system (QMS) are described. Management responsibility, Processes realization, Measurement, analysis (assessment) and improvement of the quality management system, Cancellation provision as well as abbreviations used in the Quality Manual are presented.

  3. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

    Science.gov (United States)

    Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

    2011-04-01

    The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

  4. Knowledge management in the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin

    2006-01-01

    In 2006, the Argentine Nuclear Regulatory Authority has initiated a regulatory knowledge management process to face the loss of knowledge resulting from retiring experts, the generation gap, and the existing need to train new human resources. A number of projects have been started together with the technical assistance of the National Public Administration Institute to preserve knowledge and render it explicit for the coming generations. These projects include 'The History of the Expert's Learning Process' in which the majority of the most critical experts have been interviewed so far. The results of this project help envision a training structure and prospective projects. An Internet Site has also been created on the Intranet in order to render knowledge explicit and facilitate the tools for knowledge management initiatives. Furthermore, ARN's knowledge map project has also been started. (author) [es

  5. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2003

    International Nuclear Information System (INIS)

    Seliga, M.

    2004-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2003 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; Appendix: Abbreviations; Radiation safety

  6. The bibliographical documentation in the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Carregado, M.A.

    1998-01-01

    Full text: The presentation of the following work serves to display the recourses which the Information Center (I.C.) - Ezeiza Sector of the Nuclear Regulatory Authority of the Argentine Republic possesses. These recourses help the investigation and application of the regulatory subject as well as the scientific technical community, which uses the information about radiation protection and nuclear safety. Periodical publications, reports, books, standards, etc., are specified quantitatively in detail. Mainly, the automated means are emphasized in order to get to safe ways of information. Data bases in CD-ROM are also enumerated. These are now essential in order to track down the expert information on each theme. The most outstanding ones among these data bases are: INIS, Nuclear Science Abstracts, Nuclear Regulatory Library, Medline and Poltox. Some recourses for obtaining important documents are mentioned, e.g.: The British Library, HMSO and NTIS, as well as addresses of institutions, catalogues of publication on Internet, etc., which allow an easy access to the bibliography required. An evaluation of periodical publications by the Information Center is carried out, as well as information about users connected to the request of bibliographical searches and documents. (author) [es

  7. 77 FR 24748 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-04-25

    ... Traded TBA April 18, 2012. I. Introduction On March 1, 2012, the Financial Industry Regulatory Authority... (``MBS'') traded ``to be announced'' or ``TBA.'' The proposed rule change was published for comment in... TBA (``MBS TBA'') are a specific type of Asset-Backed Security.\\6\\ FINRA has proposed to amend its...

  8. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2004

    International Nuclear Information System (INIS)

    Seliga, M.

    2005-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2004 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear power plants; (3.1) Assessment and inspection of other nuclear installations; (3.2) Safety analyses; (4) Nuclear materials and physical protection of nuclear installations; (5) Radioactive waste; (6) Quality assurance; (7) Personnel qualification and training; (8) Emergency preparedness; (9) International co-operation; (10) Public information; (11) Personnel and economy data; Appendix: Abbreviations; INES

  9. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2001

    International Nuclear Information System (INIS)

    Seliga, M.

    2002-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2001 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste (RAW); (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; (13) Conclusion; (14) Appendix: Abbreviations; Radiation safety

  10. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    Science.gov (United States)

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

    Science.gov (United States)

    Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

    2017-11-01

    Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

  12. Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

    Science.gov (United States)

    Pérez-Ibarbia, Leire; Majdanski, Tobias; Schubert, Stephanie; Windhab, Norbert; Schubert, Ulrich S

    2016-10-10

    Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. Communications in the Nuclear Regulatory Authority of the Slovakia

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1998-01-01

    Full text: The Nuclear Regulatory Authority of the Slovak Republic (UJD SR) as the state authority provides information related to its competence, namely information on safety operation of nuclear installations, independently from nuclear operators and it enables the public and media to examine information on nuclear facilities. The important aspect is proving that the nuclear energy in the Slovak Republic is due to obligatory rules acceptable and its operation is regulated by the State through the independent institution - UJD SR. UJD SR considers the whole area of public relations as essential component of its activity. UJD SR intends to serve the public true, systematic, qualified, understandable and independent information regarding nuclear safety of nuclear power plants, as well as regarding methods and results of UJD SR work. Communication on reactor incidents or more broadly on operational events at nuclear power plants represents a substantial part of public information- Generally, public information is considered as significant contribution to creation of confidence into the regulatory work. A communication programme must be tested in practice. Our communication programme is regularly evaluated in emergency exercises held at the UJD SR. Inviting journalists to participate in or observe the exercises has intensified this, or by having staff members simulate the mass media and the public. The communication means, tools and channels developed and enhanced during the recent years has increased the UJD SR's functional capability to carry out its information policy. However, communication cannot achieve its goals unless the receiver is willing to accept the message. If the receiver is suspicious about the sender's intentions, good communication is almost impossible. Maintaining the trust with the media and the public as well as increasing radiation and nuclear safety knowledge in the society is therefore essential. UJD SR communication and information activities

  14. Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

    Science.gov (United States)

    Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

    2014-12-01

    The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  15. Internal communication within the Slovak Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    2000-01-01

    One of the primary objectives of the Slovak Nuclear Regulatory Authority (UJD) Public Relations Program is to make available to the public full and complete information on UJD activities to assist the public in making informed judgments regarding UJD activities. The primary means of keeping the public informed about the regulatory activities and programs of the UJD is through the news media. A central state administration body, the UJD provides on request within its province in particular information on operational safety of nuclear energy installations independently of those responsible for the nuclear programme, thereby allowing the public and the media to control data and information on nuclear installations. A major element of providing information is the demonstration that the area of nuclear energy uses has its binding rules in the Slovak Republic and the observance thereof is controlled by the state through an independent institution - UJD. As early as 1995 were laid on the UJD the foundations of the concept of broadly keeping the public informed on UJD activity and the safety of nuclear installations by opening the UJD Information Centre. Information Centre provides by its activity communications with the public and mass media, which is instrumental in creating in the public a favourable picture of the independent state nuclear regulation. Internal and external communications are equally important

  16. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2002

    International Nuclear Information System (INIS)

    Seliga, M.

    2003-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2002 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; Appendix: Abbreviations; Special Enclosure: 10. Years of the Nuclear Regulation Authority of the Slovak Republic. An independent and professional state regulatory authority supervising the nuclear safety is one of prerequisites of the safe operation of nuclear installations in each country. In the Slovak Republic this role has been fulfilled by the Nuclear Regulatory Authority (UJD) since 1993. The main mission of UJD set down by the law is to guarantee for the Slovak citizens as well as for international society that the nuclear power on the territory of the Slovak Republic will be used exclusively for peaceful purposes and that the Slovak nuclear installations are designed, constructed, operated and decommissioned in compliance with relevant legal documents. The mission of UJD is also to tender the operation of nuclear installations so that their operation would not jeopardise the nuclear power plant staff or public and would not cause detrimental effects to the environment or property. UJD prepares laws or comments to the laws and issues decrees in the area of its competencies, issues authorisations for operators of nuclear facilities, reviews and evaluates the safety documentation of nuclear installations, performs the inspections at nuclear installations comparing whether the legal requirements are fulfilled and whether the real status of nuclear installations and their operation is or not in compliance with

  17. Author Self-disclosure Compared with Pharmaceutical Company Reporting of Physician Payments.

    Science.gov (United States)

    Alhamoud, Hani A; Dudum, Ramzi; Young, Heather A; Choi, Brian G

    2016-01-01

    Industry manufacturers are required by the Sunshine Act to disclose payments to physicians. These data recently became publicly available, but some manufacturers prereleased their data since 2009. We tested the hypotheses that there would be discrepancies between manufacturers' and physicians' disclosures. The financial disclosures by authors of all 39 American College of Cardiology and American Heart Association guidelines between 2009 and 2012 were matched to the public disclosures of 15 pharmaceutical companies during that same period. Duplicate authors across guidelines were assessed independently. Per the guidelines, payments disclosure was poor (κ = 0.238). There was a significant difference in error rates of disclosure among companies and authors (P = .019). Of disclosures by authors, companies failed to match them with an error rate of 71.6%. Of disclosures by companies, authors failed to match them with an error rate of 54.7%. Our analysis shows a concerning level of disagreement between guideline authors' and pharmaceutical companies' disclosures. Without ability for physicians to challenge reports, it is unclear whether these discrepancies reflect undisclosed relationships with industry or errors in reporting, and caution should be advised in interpretation of data from the Sunshine Act. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Radiation protection databases of nuclear safety regulatory authority

    International Nuclear Information System (INIS)

    Janzekovic, H.; Vokal, B.; Krizman, M.

    2003-01-01

    Radiation protection and nuclear safety of nuclear installations have a common objective, protection against ionising radiation. The operational safety of a nuclear power plant is evaluated using performance indicators as for instance collective radiation exposure, unit capability factor, unplanned capability loss factor, etc. As stated by WANO (World Association of Nuclear Operators) the performance indicators are 'a management tool so each operator can monitor its own performance and progress, set challenging goals for improvement and consistently compare performance with that of other plants or industry'. In order to make the analysis of the performance indicators feasible to an operator as well as to regulatory authorities a suitable database should be created based on the data related to a facility or facilities. Moreover, the international bodies found out that the comparison of radiation protection in nuclear facilities in different countries could be feasible only if the databases with well defined parameters are established. The article will briefly describe the development of international databases regarding radiation protection related to nuclear facilities. The issues related to the possible development of the efficient radiation protection control of a nuclear facility based on experience of the Slovenian Nuclear Safety Administration will be presented. (author)

  19. Virtual private networks application in Nuclear Regulatory Authority of Argentina

    International Nuclear Information System (INIS)

    Glidewell, Donnie D.; Smartt, Heidi A.; Caskey, Susan A.; Bonino, Anibal D.; Perez, Adrian C.; Pardo, German R.; Vigile, Rodolfo S.; Krimer, Mario

    2004-01-01

    As the result of the existence of several regional delegations all over the country, a requirement was made to conform a secure data interchange structure. This would make possible the interconnection of these facilities and their communication with the Autoridad Regulatoria Nuclear (ARN) headquarters. The records these parts exchange are often of classified nature, including sensitive data by the local safeguards inspectors. On the other hand, the establishment of this network should simplify the access of authorized nuclear and radioactive materials users to the ARN databases, from remote sites and with significant trust levels. These requirements called for a network that should be not only private but also secure, providing data centralization and integrity assurance with a strict user control. The first proposal was to implement a point to point link between the installations. This proposal was deemed as economically not viable, and it had the disadvantage of not being easily reconfigurable. The availability of new technologies, and the accomplishment of the Action Sheet 11 under an agreement between Argentine Nuclear Regulatory Authority and the United States Department of Energy (DOE), opened a new path towards the resolution of this problem. By application of updated tunneling security protocols it was possible to project a manageable and secure network through the use of Virtual Private Networking (VPN) hardware. A first trial installation of this technology was implemented between ARN headquarters at Buenos Aires and the Southern Region Office at Bariloche, Argentina. This private net is at the moment under test, and it is planned to expand to more sites in this country, reaching for example to nuclear power plants. The Bariloche installation had some interesting peculiarities. The solutions proposed to them revealed to be very useful during the development of the network expansion plans, as they showed how to adapt the VPN technical requisites to the

  20. Dose constraint for Industrial gammagraphy developed by regulatory authorities

    International Nuclear Information System (INIS)

    Salinas Mariaca, Rodrigo

    2008-01-01

    Aware that the dose limitation established by the Basic Safety Standards, is one of the radiation protection requirements necessary but not sufficient; and also aware that given the characteristics of the different practices and the culture of security already achieved in such practices, the workers occupationally exposed are far below from the respective limits. It becomes imperative to improve and exploit another of the requirements established by the referred standards, which is the Dose Constraint. This job takes as a basis the dose history having in the Bolivian Authority in nuclear issues, referred to the practices related to Nuclear Gauges, Well Logging, Radiotherapy and Industrial Gammagraphy (practices considered dangerous). This analysis is intended to be the pivot for the remainder practices and had as its goal, the establishment of a specific dose constraint value. The dose constraint suggested for every practices studied, were determined considering the percentile 95 and with the logic that if that 95% are able to achieve certain values of effective dose, the other 5% should be able to adapt their working conditions in order to decrease their doses. The spread of this work is intended not only aware, to other regulatory bodies to achieve a symbiosis between the different requirements of the Standard, but basically emphasize the fact that it is not convenient let the requirement of dose constraint exclusively in the hands of the regulated institutions and associated workers; making it, very subjective among those institutions according to their analysis (many times with no statistical support). Furthermore these dose constraint values should be determined previously to a new practice authorization or failing shortly after its implementation. (author)

  1. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

    Science.gov (United States)

    Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

    Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

  2. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

  3. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  4. Creating a safety culture in the regulatory authority: The Cuban experience

    International Nuclear Information System (INIS)

    Ferro Fernandez, R.; Guillen Campos, A.

    2002-01-01

    The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

  5. 77 FR 12098 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule... FINRA and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

  6. 76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory...

  7. 76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

  8. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2012

    International Nuclear Information System (INIS)

    2013-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2012 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Stress tests on the nuclear power plants; (5) Nuclear Materials in SR; (6) Building Authority; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) Attachments; (12) Abbreviations used.

  9. Infrastructure of the Regulatory Authority and Performance Indexes

    International Nuclear Information System (INIS)

    Velasquez, Silvia

    2001-01-01

    This presentation overviews the following issues: elements of a control regulatory program, inspections program, procedures, indexes of users performance, priorities on: registration, criteria for practices of low risk, dose levels in medical exposures, dose constraints and training of personnel. These aspects are considered in the guides prepared within ARCAL XX framework

  10. Role of cooperation activities for capacity building of Romanian Regulatory Authority (CNCAN)

    International Nuclear Information System (INIS)

    Biro, L.; Ciurea-Ercau, C.

    2010-01-01

    With a slow but active nuclear development program of sector since 1980, Romanian regulatory authority had to permanently adapt to the changes in national and international environment in order ensure continuously increase of capacity building and effectiveness, commensurate with the growing nuclear sector. Limited human resources available at the national level put the Romanian Regulatory Authority in the position of building the Technical Support Organization as part of its on organization. International cooperation played an important role in capacity building of Romanian regulatory body and providing necessary assistance in performing regulatory activities or support in development of regulatory framework. Fellowships and technical visits, workshops and training courses provided through IAEA TC at national or regional level, technical assistance provided by European Commission (EC) through PHARE Projects, all provided valuable contribution in assuring training of regulatory staff and development of proper regulatory framework in Romania. Therefore, Romanian Regulatory Authority is putting a strong accent on strengthening and promoting international cooperation through IAEA Technical Cooperation Programme, Molls between regulatory bodies, as one of the key elements in supporting capacity building of regulatory authorities in countries having small or embarking on nuclear power program. Building networks between training centers and research facilities and establishments of regional training centers represent one of the future viable options in preserving knowledge in nuclear field. (author)

  11. Role of the Nuclear Regulatory Authority in the final disposal of radioactive wastes in Argentina

    International Nuclear Information System (INIS)

    Petraitis, E.J.; Siraky, G.; Novo, R.G.

    1998-01-01

    This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. The activities of the Nuclear Regulatory Authority (ARN) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. (author) [es

  12. Towards medicines regulatory authorities' quality performance improvement: value for public health.

    Science.gov (United States)

    Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina

    2016-01-01

    The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright © 2014 John Wiley & Sons, Ltd.

  13. 75 FR 52380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-25

    ... recent outsourcing of surveillance and other regulatory functions to FINRA.\\8\\ Specifically, to have... with NASD IM-1013-1 or NASD IM-1013-2, including limiting its business operations to ``permitted floor... NASD IM-1013-2 establish a waive-in membership application process for certain firms to become FINRA...

  14. 78 FR 4186 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-01-18

    ... securities offered or sold pursuant to crowdfunding.\\5\\ Intermediaries in transactions involving the offer or sale of securities for the account of others pursuant to the crowdfunding exemption must, among other...- regulatory organization.\\7\\ \\4\\ Public Law 112-106, 126 Stat. 306 (2012). \\5\\ In general, crowdfunding refers...

  15. 75 FR 75529 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-12-03

    ... advance notice of the new Verification of Assets rule. \\8\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63383; File No. SR-FINRA-2010-062] Self... in SR-FINRA-2010-042 (Verification of Assets) November 29, 2010. Pursuant to Section 19(b)(1) of the...

  16. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing... (Disclosure of Price and Concessions in Selling Agreements) and the deletion of NASD Rule 2770 (Disclosure of Price in Selling Agreements). FINRA Rule 5160 was approved by the Commission on January 25, 2010 \\5\\ and...

  17. 77 FR 8938 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-15

    ... expenses as ``other'' (miscellaneous), a very general categorization that provides FINRA limited visibility... supplemental filing would play with respect to a broker-dealer's annual audit.\\28\\ \\26\\ CAI. \\27\\ Id. \\28\\ Id... any future schedules or reports be done through the more typical self- regulatory organization (``SRO...

  18. Annual Report 2007. Nuclear Regulatory Authority; Informe Anual 2007. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  19. Annual Report 2008. Nuclear Regulatory Authority; Informe Anual 2008. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  20. Annual Report 2009. Nuclear Regulatory Authority; Informe Anual 2009. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  1. Responsibilities of nuclear regulatory authority and overview of nuclear safety regulations in Slovakia

    International Nuclear Information System (INIS)

    Misak, J.

    1996-01-01

    The paper describes the organizational structure of the Nuclear Regulatory Authority of the Slovak Republic, its rights and duties, the status of nuclear legislation with emphasis on nuclear activities completely or partially covered, and licensing procedures

  2. Below regulatory concern standards: The limits of state and local authority

    International Nuclear Information System (INIS)

    Silverman, D.J.

    1990-01-01

    The paper discusses: (1) the scope of the Nuclear Regulatory Commission's authority to develop and implement below regulatory concern or BRC standards; and (2) the limitations on the legal authority of states and local governments to create impediments to full implementation of such standards. The paper demonstrates that the NRC is acting well within its statutory authority in developing BRC regulations and guidelines, and that the ability of state and local governments to impede generators' use of those regulations and guidelines on the basis of legal or regulatory initiatives is substantially circumscribed. While some generators may be reluctant, as a result of political factors, to utilize BRC standards, the decision whether or not to use such standards should not be made without careful consideration of the applicable legal and regulatory limitations on state and local authority

  3. Development of the personnel training and qualification system of the Russian Federation Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.

    2006-01-01

    The new personnel training and qualification system is being developed for russian regulatory body, having a very big number of employees and invited experts and widly territorially distributed structure. (author)

  4. 75 FR 48731 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62655; File No. SR-FINRA-2010-042] Self... Change To Adopt FINRA Rule 4160 (Verification of Assets) August 5, 2010. Pursuant to Section 19(b)(1) of... rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  5. The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian; Buettiker, Jean-Pierre; Roehl, Holger; Lam, Philippe; Brown, Helen; Luemkemann, Joerg; Adler, Michael; Huwyler, Joerg; Streubel, Alexander; Mohl, Silke

    2016-02-01

    Parenteral drug products are protected by appropriate primary packaging to protect against environmental factors, including potential microbial contamination during shelf life duration. The most commonly used CCS configuration for parenteral drug products is the glass vial, sealed with a rubber stopper and an aluminum crimp cap. In combination with an adequately designed and controlled aseptic fill/finish processes, a well-designed and characterized capping process is indispensable to ensure product quality and integrity and to minimize rejections during the manufacturing process. In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described. Different capping techniques are critically compared: The most common capping equipment with a rotating capping plate produces the lowest amount of particle. The strength and challenges of methods to control the capping process are discussed. The residual seal force method can characterize the capping process independent of the used capping equipment or CCS. We analyze the root causes of several cosmetic defects associated with the vial capping process. Copyright © 2015 Elsevier B.V. All rights reserved.

  6. 75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-09

    ... related to fraud or securities laws violations; \\10\\ (4) a government authority or regulator has provided... related to fraud or securities laws violations; \\14\\ (4) a government authority or regulator has provided... potentially violating an anti-fraud rule of the Federal securities laws and stated that where it has actual...

  7. 77 FR 67038 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-11-08

    ... of Functions by FINRA to Subsidiaries (``Delegation Plan''), the NAMC has the power and authority... such other powers and authority as is necessary to effectuate the purposes of FINRA's Rules.\\7\\ The... knowledge. [T]hen the situation could be deemed a legal case.'' The Commission believes that the commenter...

  8. Provincial nuclear regulatory authority?: The case of the province of Cordoba

    International Nuclear Information System (INIS)

    Martin, Hugo; Ocana, F.; Scoles, R.

    1999-01-01

    The evolution of social and political events in the province of Cordoba after the Law 8157 of 1992, that establishes the provincial nuclear policy, are analysed as well as the recent sanction and veto of the Law 8775, which creates the provincial Nuclear Regulatory Authority. The authors conclude that is necessary and convenient to enforce provincial nuclear regulations and controls

  9. 76 FR 61429 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-04

    ... stress, along with a policy statement by FINRA (then known as NASD) that provided trading halt authority... a period of significant stress. \\11\\ See Securities Exchange Act Release No. 58753 (October 8, 2008... submit written data, views, and arguments concerning the foregoing, including whether the proposed...

  10. 77 FR 74249 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-12-13

    ... System (``FINRA ADDS'') is a secure Web site that provides a firm, by market participant identifier... generates a separate report for each data archive (Asset-Backed Securities or Corporate/Agency Debt..., 2013. For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.\\11...

  11. Revolution in New Zealand's Radiation Protection Legislation and Evolution and Continual Improvement in its Regulatory Authority

    International Nuclear Information System (INIS)

    Smyth, V.

    2004-01-01

    The safe use of ionising radiation in New Zealand is regulated by the Radiation Protection Act 1965 and the Radiation Protection Regulations 1982, which are administered by the National Radiation Laboratory (NRL). This legislation is now out of date and creates difficulties for New Zealand in meeting international standards of radiation safety and security, and complying with obligations under international treaties. These problems can be addressed by new legislation that would change the powers and functions of the regulatory authority, and change the responsibilities of licensees under the Act. However historically NRL has provided radiation services as well as acting as regulatory authority. This has the potential to create a conflict of interest in making regulatory judgements. Over the preceding 50 years NRL has undergone an evolution that has resulted in a clarification of the regulatory functions, and development of a quality management system that is now accredited to ISO standards. This paper presents a possible structure of a new Act, and discusses the role of quality management in maintaining the independence of regulatory authority. (Author)

  12. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

    Science.gov (United States)

    Sistare, Frank D; Morton, Daniel; Alden, Carl; Christensen, Joel; Keller, Douglas; Jonghe, Sandra De; Storer, Richard D; Reddy, M Vijayaraj; Kraynak, Andrew; Trela, Bruce; Bienvenu, Jean-Guy; Bjurström, Sivert; Bosmans, Vanessa; Brewster, David; Colman, Karyn; Dominick, Mark; Evans, John; Hailey, James R; Kinter, Lewis; Liu, Matt; Mahrt, Charles; Marien, Dirk; Myer, James; Perry, Richard; Potenta, Daniel; Roth, Arthur; Sherratt, Philip; Singer, Thomas; Slim, Rabih; Soper, Keith; Fransson-Steen, Ronny; Stoltz, James; Turner, Oliver; Turnquist, Susan; van Heerden, Marjolein; Woicke, Jochen; DeGeorge, Joseph J

    2011-06-01

    Data collected from 182 marketed and nonmarketed pharmaceuticals demonstrate that there is little value gained in conducting a rat two-year carcinogenicity study for compounds that lack: (1) histopathologic risk factors for rat neoplasia in chronic toxicology studies, (2) evidence of hormonal perturbation, and (3) positive genetic toxicology results. Using a single positive result among these three criteria as a test for outcome in the two-year study, fifty-two of sixty-six rat tumorigens were correctly identified, yielding 79% test sensitivity. When all three criteria were negative, sixty-two of seventy-six pharmaceuticals (82%) were correctly predicted to be rat noncarcinogens. The fourteen rat false negatives had two-year study findings of questionable human relevance. Applying these criteria to eighty-six additional chemicals identified by the International Agency for Research on Cancer as likely human carcinogens and to drugs withdrawn from the market for carcinogenicity concerns confirmed their sensitivity for predicting rat carcinogenicity outcome. These analyses support a proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six-month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study. This proposed decision paradigm has the potential to eliminate over 40% of rat two-year testing on new pharmaceuticals without compromise to patient safety.

  13. Extent and content of data for regulatory submissions: First-in-human and marketing authorization--Viewpoint of US industry.

    Science.gov (United States)

    Harris, Ian Ross

    2015-09-01

    The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committee for Advanced Therapies (CAT) have considerable experience in regulating cell therapies and have provided extensive Guidance documents for developers. The Agencies offers advice to Sponsors through a variety of meetings. However, it is incumbent on the Sponsor to understand the regulations, interpret the Guidance documents and formulate clear company positions to enable the Agency to provide clear feedback. It is important for Sponsors to understand the factors that are critical for the safety and efficacy of their product and to demonstrate to the Health Authorities that they have a control strategy that ensures safety and efficacy during all stages of development. The focus of this paper is to describe some of the challenges for the chemistry manufacturing and controls (CMC) for cell therapies being development internationally. Copyright © 2015.

  14. A National Regulatory Authority set up in a developing country: case of Mali

    International Nuclear Information System (INIS)

    Kone, Nagantie

    2008-01-01

    Full text: The Republic of Mali is member of the International Atomic Energy Agency since 1961. Of since the creation of the IAEA, some African countries are members. The technical cooperation with the Agency started in the years 1975. Through that cooperation, many pacific uses of nuclear techniques have been introduced, then developed at different levels in many socio- economic domains as medicine, agriculture, research, and so on. That development of nuclear techniques use has occurred without legislation at all or in some limited cases with part of the legislation of the colonizing country), in a precise field (like radiography in medicine). Later the need of regulatory infrastructure implementation started. That implementation has followed several ways in the different African countries. Also, it started earlier in countries which had advanced activities in nuclear techniques and very later in others. Most if not all of these infrastructure (say regulatory board) were created by the greatest users of the nuclear techniques, the Ministry of Health in most cases or Energy Commission for Countries having a research reactor. After the years 90, the Agency has developed new vision in the implementation of Regulatory Authorities. The new innovation was: 1-) Development of Regulatory Authority with independent statute (decisions and finance); 2-) Assuming post graduate training in developing countries to come other the lack of human resources. That new strategy of the IAEA has facilitated the apparition and development of several new regulatory authorities. We are going to develop here the progress done by one of these new regulatory authorities, through five years being. (author)

  15. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

  16. ILK statement about the regulatory authorities' perception of operators' self-assessment of safety culture

    International Nuclear Information System (INIS)

    2005-01-01

    Over the past few years, German licensing and supervisory authorities have devoted increasing attention to safety management and safety culture issues. At present, German plant operators are introducing systems for self-assessment of the safety culture in their plants, such as the Safety Culture Assessment System developed by VGB Power Tech (VGB-SBS). In its statement, the International Committee on Nuclear Technology (ILK) addresses an effective approach of the authorities in evaluating the self-assessment of safety culture conducted by operators. ILK proposes a total of ten recommendations for evaluating the self-assessment system of the operators by the authority. The regulatory authorities should see to it that the operators establish a self-assessment system for aspects of organization and personnel, and use it continuously. The measures derived from this self-assessment by the operators, and the reasons underlying them, should be discussed with the authorities. In addition to the operators, also the regulatory authorities and the technical expert organizations commissioned by them should carry out self-assessments of their respective supervisory activities, taking into account also special events, such as changes in government, and develop appropriate programs of measures to be taken. In evaluating safety culture, the regulatory authorities should strive to support the activities of operators in improving their safety culture. A spirit of mutual confidence and cooperation should exist between operators and authorities. The recommendations expressed in the statement deliberately leave room for detailed implementation by the parties concerned. (orig.)

  17. Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    areas of inspection and public communication as a consequence of the lessons learned in 2008 from the event at the Asco Nuclear Power Plant; CSN's interactions at the highest level with licensees to discuss strategic planning and their investments in safety and human resources; and The establishment of formal frameworks for cooperation between the CSN and several governmental organizations, such as the Ministry of Health and the Ministry of Interior in the areas of radiation protection and security. Carmen Martinez Ten, President of CSN, said, 'I am proud that Spain is among the first countries to have received a full- scope IRRS mission and a follow-up. CSN has benefitted from the IRRS mission using the contribution from senior regulators which has resulted and will continue in further improvements in our regulatory framework.' The IRRS team also made recommendations and suggestions to further strengthen Spain's regulatory body, including: CSN should establish a formal policy on how to use technical advisory bodies for technical regulatory decisions; CSN should continue to work with relevant bodies to prepare for the disposal of spent fuel and high-level waste, taking into account the progress being made in the siting of a storage facility; and CSN should continue to work with relevant competent authorities and other bodies on regulatory aspects of security. Denis Flory, IAEA Deputy Director General for Nuclear Safety and Security, said, 'This mission is a clear example of the value of regulatory bodies participating in a senior peer review process offered by IAEA. A particularly important feature of these IRRS follow-up missions is to assess the effective implementation of the recommendations made. This mission to Spain also demonstrates clearly the mutual interest of IRRS missions: they encourage improvements in the host countries and serve as valuable sources of information for the reviewers themselves and for other regulatory bodies.' (IAEA)

  18. The Nuclear Regulatory Authority of the Slovak Republic - information to the public

    International Nuclear Information System (INIS)

    Seliga, M.

    1998-01-01

    In this paper the communication programme in the Nuclear Regulatory Authority of the Slovak Republic (NRA SR), internal communication within NRA SR, handling the media, the media documents, the emergency preparedness and media as well as the activities of the NRA SR in last period are discussed

  19. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    International Nuclear Information System (INIS)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-01

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  20. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    Energy Technology Data Exchange (ETDEWEB)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-15

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  1. The knowledge management and the Library of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin; Carregado, Maria A.

    2009-01-01

    Since 2006 the Nuclear Regulatory Authority (ARN) of Argentina has implemented knowledge management activities to face the retirement of many of its scientific and technical members. The purpose of these actions are to preserve the knowledge and information of these personnel and to make it available for both, present and future generations. The ARN libraries play an important role in the accomplishment of these objectives through the coordination and realization of different projects and activities. (author) [es

  2. Intercomparison run for uranium and tritium determination in urine samples, organised by Nuclear Regulatory Authority, Argentina

    International Nuclear Information System (INIS)

    Serdeiro, Nelida H.; Equillor, Hugo E.; Bonino, Nestor O.

    2003-01-01

    The Nuclear Regulatory Authority (ARN), Argentina, has carried out an intercomparison run for tritium and uranium determination in urine, in November 2002. The aim of this exercise was to assess the performance of the laboratories that usually inform these radionuclides and to provide technical support in order to have an appropriate occupational monitoring in vitro. In the present work, the results of the intercomparison and the assessment of each laboratory are published. (author)

  3. NRPA develops regulatory cooperation with Central Asian authorities for nuclear safety and radiation protection

    International Nuclear Information System (INIS)

    2009-01-01

    With the support of the Norwegian Ministry of Foreign Affairs, the NRPA has initiated a regional regulatory cooperation project with Kazakhstan, Kyrgyzstan and Tajikistan to improve regulations on nuclear safety, radiation protection and environmental issues, and assist the countries in re mediating radioactively contaminated sites. There is a critical lack in the regulatory basis for carrying out such remediation work, including a lack of relevant radiation and environmental safety norms and standards, licensing procedures and requirements for monitoring, as well as expertise to transform such a basis into practice. (Author)

  4. [Regulatory science: modern trends in science and education for pharmaceutical products].

    Science.gov (United States)

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  5. Activities of Nuclear Regulatory Authority and safety of nuclear facilities in the Slovak Republic in 1993

    International Nuclear Information System (INIS)

    1994-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1993 is presented. These activities are reported under the headings: (1) Introduction; (2) Regulatory activities at nuclear power plants units in operation; (2.1) Nuclear power plant SEP-EBO V-1; (4) Selected operation events and safety assessment in NPP SEP-EBO V-1; (2.2) Safety assessment of NPP SEP-EBO V-2; (3) Results of regulatory activities at the decommissioning of NPP A-1; (4) Regulatory activities at units under construction SEP-EMO - NPP Mochovce; (5) Further regulatory activities. (5.1) Preparation of designated personnel; (5.2) Inspection and accountancy of nuclear material; (5.3) Security provisions; (5.4) Accounted items and double use items; (5.5) Problem of radioactive wastes; (6.1) International co-operation activities of NRA; (6.2) Emergency planning; (6.3) International activities for quality enhancement of national supervision; (7) Conclusion [sk

  6. Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: Expert opinions on the state of affairs and the way forward

    NARCIS (Netherlands)

    Schiffelers, M.J.W.A.; Blaauboer, B.J.; Bakker, W.E.; Beken, S.; Hendriksen, C.F.M.; Koeter, H.; Krul, C.A.M.

    2014-01-01

    Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these

  7. 75 FR 38986 - Grant of Authority for Subzone Status; Schwarz Pharma Manufacturing, Inc. (Pharmaceutical...

    Science.gov (United States)

    2010-07-07

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 1686] Grant of Authority for Subzone... expedite and encourage foreign commerce, and for other purposes,'' and authorizes the Foreign-Trade Zones... cannot serve the specific use involved, and when the activity results in a significant public benefit and...

  8. An overview of the licensing approach of the South African nuclear regulatory authority

    International Nuclear Information System (INIS)

    Clapisson, G.A.; Hill, T.F.; Henderson, N.R.; Keenan, N.H.; Metcalf, P.E.; Mysenkov, A.

    1997-01-01

    This paper describes the approach adopted by the South African Nuclear Regulatory Authority, the Council for Nuclear Safety (CNS) in licensing nuclear installations in South Africa. An introduction to the current South African legislation and the CNS philosophy pertaining to the licensing of nuclear installations is discussed. A typical process for granting a nuclear licence is then presented. The risk assessment process, which is used to verify compliance with the fundamental safety standards and to establish licensing requirements for a specific nuclear installation, is discussed. Based on the outcome of this assessment process, conditions of licence are set down. The generic content of a nuclear licence and mechanisms to ensure ongoing compliance with the risk criteria are presented. The regulatory process discussed in this paper, based on such a fundamental approach, may be adapted to any type of nuclear installation taking into account plant specific designs and characteristics. (author)

  9. International conference on strengthening of nuclear safety in Eastern Europe. Armenian Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Nersesyan, V.

    1999-01-01

    The status of the Armenian Nuclear Regulatory Authority (ANRA) are described in detail with its main task and responsibilities concerning regulations and surveillance of nuclear and radiation safety. The following issues are presented: nuclear legislation; inspection activities; licensing of significant safety related modifications and modernization of NPPs; incidents at NPPs; personnel training; emergency planning; surveillance of nuclear materials; radioactive waste management; and plan of the ANRA perspective development

  10. Intercomparison run for uranium and tritium determination in urine samples, organised by Nuclear Regulatory Authority, Argentina

    CERN Document Server

    Serdeiro, N H; Equillor, H E

    2003-01-01

    The Nuclear Regulatory Authority (ARN), Argentina, has carried out an intercomparison run for tritium and uranium determination in urine, in November 2002. The aim of this exercise was to assess the performance of the laboratories that usually inform these radionuclides and to provide technical support in order to have an appropriate occupational monitoring in vitro. In the present work, the results of the intercomparison and the assessment of each laboratory are published.

  11. Participation of the Nuclear Regulatory Authority in the uranium urinalysis intercomparisons

    International Nuclear Information System (INIS)

    Bonino, Nestor O.; Palacios, Miguel A.; Serdeiro, Nelida H.

    1999-01-01

    In the present work the results of the participation of Nuclear Regulatory Authority (NRA) Argentina, in the Uranium Urinalysis Intercomparison Program administered by the National Calibration Reference Centre for Bioassay, Radiation Protection Bureau, Health Canada, are detailed. This work is referred to the three participations of NRA in 1995, 1996, and 1997. The number of laboratories that have participated was 14, 12 and 12. A statistical analysis is presented. The performance criteria used for assessing the acceptability of results are those given in the American National Standard Institute (ANSI) 1989, N13.30. In addition, the applied radiochemical technique and the methodology are described. (author)

  12. Employee Development Capabilities of the Regulatory Authority in the Nuclear Field in Romania

    International Nuclear Information System (INIS)

    Ghinea, P.

    2016-01-01

    Full text: The paper provides information about CNCAN (general presentation of CNCAN responsibilities as a regulatory body) and about the general human resources management within our institution regarding the following: legal framework regarding resources; knowledge management; staff employment financial resources continuous focus on improvement of staff performances through dedicated training programmes. The process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. Training for CNCAN staff is provided either in-house or through technical cooperation programmes with the IAEA. CNCAN has made arrangements for specific staff training using training courses and programmes provided by international organizations. The specific training is provided predominantly with the economic support from outside of the country. CNCAN has a process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. To maintain an appropriate competence level, an annual plan for staff training is in place and each staff member has an individual training plan. Project supports CNCAN in the development of knowledge management and capacity building frameworks to secure long-term availability of regulatory competency. (author

  13. The mass media role in acceptance activities of Slovak Republic's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1998-01-01

    Communication is the vital link between Nuclear Regulatory Authority and the public. If people do not know and understand the facts on which optimal a safety energy choice decisions should be based they cannot make informed decisions on how their own objectives can be met. The following ten commandments of communications are pointed out: be yourself; be comfortable and confident; be honest; be brief; be human; be personal; be positive and consistent; be attentive; be energetic; be committed and sincere. The important aspect is to test whether the nuclear energy in the Slovak Republic is acceptable according to mandatory rules and if its operation is regulated by the state through the independent institution - the Nuclear Regulatory Authority of the Slovak Republic (UJD). The media in Slovakia has on important power. Many organizations are therefore apprehensive when dealing with the press, radio and television. Many people would simply prefer not to get panicked when the dreaded microphones and cameras do appear. UJD considers the whole area of public relations as an essential component of its activity. UJD intends to offer the public true, systematic, qualified, understandable and independent information, regarding the safety of nuclear power plants, as well as regarding the methods and results of UJD work. Generally, public information is considered a significant contribution to the creation of confidence into the regulatory work. The paper presents the UJD communication program and relations with media as well as the preparedness of public information in case of emergency

  14. Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

    Science.gov (United States)

    Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

    2018-03-30

    The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

  15. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

    Science.gov (United States)

    Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

    2014-01-01

    When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

  16. TSO Role in Supporting the Regulatory Authority in View of Safety Culture

    International Nuclear Information System (INIS)

    Khamaza, A.; Vasilishin, A.

    2016-01-01

    Human and organizational factors are always of paramount importance at nuclear and radiation safety as well as in the safety regulation provision. Major NPP accidents occurred merely reaffirm this fact. The role of an authority that regulates nuclear safety increases each time in the aftermath of accidents perceived as a shock together with the importance of scientific and technical support. SEC NRS was established in 1987, the next year after the Chernobyl NPP accident aiming to strengthen supervision over works carried out at the nuclear industry enterprises. Currently SEC NRS provides comprehensive scientific and technical support to Rostechnadzor including safety review and regulatory legal documents development to regulate safety along with safety culture.

  17. Regulation of Federal radioactive waste activities. Report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

    International Nuclear Information System (INIS)

    1979-09-01

    The report contains two recommendations for extending the Commission's regulatory authority: (1) NRC licensing authority should be extended to cover all new DOE facilities for disposal of transuranic (TRU) waste and nondefense low-level waste. (2) A pilot program, focused on a few specific DOE waste management activities, should be established to test the feasibility of extending NRC regulatory authority on a consultative basis to DOE waste management activities not now covered by NRC's licensing authority or its extension as recommended in Recommendation 1

  18. Regulatory policy and the location of bio-pharmaceutical foreign direct investment in Europe.

    Science.gov (United States)

    Koenig, Pamina; Macgarvie, Megan

    2011-09-01

    This paper examines the relationship between cross-country differences in drug price regulation and the location of biopharmaceutical Foreign Direct Investment (FDI) in Europe. Simple theory predicts that price regulation in one country might affect total investment, but not the location of that investment, if sales are global. Nevertheless, some manufacturers threaten that the introduction of price regulation in a country will motivate them to move their investments to other countries. Are such threats cheap talk, or is there evidence that firms avoid price-controlling countries when making FDI location choices? We use data on 527 investments initiated in 27 European countries between 2002 and 2009 and find that investors are less likely to choose countries with price controls, after controlling for other determinants of investment. We also observe a relative decline in investment in countries that increased the stringency of regulatory regimes during our sample period. The effect is restricted to non-manufacturing investments and is most robust for those related to administrative functions. Copyright © 2011 Elsevier B.V. All rights reserved.

  19. Medical program in radiation protection from the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Perez, M. R.; Gisone, P.; Di Trano, J.L.; Dubner, D.L.; Michelin, S.C.

    1998-01-01

    This program is carried out by the Radio pathology Laboratory, belonging to the Nuclear Regulatory Authority. The program includes the following aspects: 1) planning and organization of medical response in radiological emergencies. A three-level system of medical assistance has been developed considering: a- determination of each level of care and their potential roles; b- choice of medical facilities for medical assistance; c- preparedness for medical response (equipment s, logistic support, human resources, training). 2) scientific research activities related to radio pathology subjects: a- hematological indicators in radioinduced aplasia; b- biological and biophysical dosimeters; c- radiation effects on the developing brain. 3) edition of practical guidelines for diagnostic and treatment: a- external and internal radioactive contamination; b- acute radiation syndrome; c- radiological burns. 4) medical advising in radioprotection (risk assessment in radiation workers, medical exposures, potential effects of prenatal irradiation). 5) international interactions: activities related with the constitution of a Latin American radio pathology network, linkage with international reference centers. (author) [es

  20. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Grebeciova, J.

    2006-01-01

    The major results are presented of the self-assessment procedure which was carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD) in 2005 based on the Common Assessment Framework (CAF) model. An overview is given of the most important preconditions and results and their interactions in the nine areas of assessment as follows: leadership, strategy and planning, human resource management, partnership and resources, process management and changes, customer and public oriented results, people results, society results, and key performance results. UJD's strengths and opportunities as emerged from the self-assessment are highlighted. The self-assessment process will be followed by the preparation and implementation of an Action Plan. (author)

  1. Role of partnership in enhancing the performance of radiation regulatory authority in Zambia

    International Nuclear Information System (INIS)

    Banda, S.C.

    2003-01-01

    The National Radiation Infrastructure includes legislation, human resource, technical capacity to execute responsibilities of the regulatory (1). In cases of developing countries like Zambia, special challenges arise in view of the constraints both in terms of human resource and funding. This paper will highlight same measures that may be undertaken to improve the operations of nation radiation protection infrastructure. The measures include collaboration with Science and Technology organisations that have technical capacity, delegation of responsible to key institutions that may have competence and generation of funds through training and provision of reliable quality service. (2). In Zambia, some achievements in this line have been registered by Radiation Protection Board working with the University of Zambia and National Institute for Scientific and Industrial Research (3). Some measures of generation of funds have been done though utilization of the generated remains to be the limiting factor to exploit fully benefits that may arise from the use of the monies generated from services. Partnerships with private sector may be used as regulatory authorities for support to its programme in particular the public awareness campaign. Sponsorship by a Private Cellar Phone Company (Telecel Zambia) and Rotary Club of Lusaka for Radiation Week to Radiation Protection Service under Theme 'Safe Radiation Use' is one such an example. The other opportunity is the technical cooperation with regional and international organisations such as SADC, IAEA, WHO, Interpol, EU and WCO for technical capacity building, human resource development and information access. (author)

  2. The Slovak nuclear regulatory authority and start-up of the Mochovce NPP

    International Nuclear Information System (INIS)

    Seliga, M.; Micankova, J.

    2000-01-01

    A major element of providing information is the demonstration that the area of nuclear energy uses has its binding rules in the Slovak Republic and the observance thereof is controlled by the state through an independent institution Slovak Nuclear Regulatory Authority (UJD). As early as 1995 were laid on the UJD the foundations of the concept of broadly keeping the public informed on UJD activity and the safety of nuclear installations by opening the UJD Information Centre that provides by its activity communications with the public and mass media, which is instrumental in creating in the public a favourable picture of the independent state nuclear regulation. Clear communication policy is the key to credibility and is based on perceptions which give ride to varying levels of confidence. It has been consistently found in opinion research that credibility is the single most powerful persuasive force. Public communication programmes are the principal currency for the Regulatory Authority to inform the public on issues like costs, benefit requirements and risks

  3. Assessment of the effectiveness of the Hungarian nuclear safety regulatory authority by international expert teams

    International Nuclear Information System (INIS)

    Voeroess, L.; Lorand, F.

    2001-01-01

    On the basis of the role nuclear regulatory authorities (NRA) have to fulfil and the new challenges affecting them, in the paper an overview is made on how the Hungarian NRA has evaluated and utilised the results of different international efforts in the enhancement of its effectiveness and efficiency. The reviews have been conducted by different groups of experts organised by highly recognised international organisations (e.g. IAEA, EC) and highly competent foreign regulatory bodies. The different reviews of activities and working conditions of the HAEA NSD have resulted in a generally positive picture, however, it also revealed weaknesses as well. They recognised the developments made in recent years and also appreciated the overall favourable level of nuclear safety in Hungary, identified 'good practices' and made recommendations and suggestions for the most important and most efficient ways for future improvements. These are cited or referenced in the paper. At the end, some recommendations have been formed based on the experiences gained from the review missions and from our self-assessment. (author)

  4. Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: expert opinions on the state of affairs and the way forward.

    Science.gov (United States)

    Schiffelers, Marie-Jeanne W A; Blaauboer, Bas J; Bakker, Wieger E; Beken, Sonja; Hendriksen, Coenraad F M; Koëter, Herman B W M; Krul, Cyrille

    2014-06-01

    Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these models must overcome many barriers before being accepted for regulatory risk management purposes. This paper describes the barriers and drivers and options to optimize this acceptance process as identified by two expert panels, one on pharmaceuticals and one on chemicals. To untangle the complex acceptance process, the multilevel perspective on technology transitions is applied. This perspective defines influences at the micro-, meso- and macro level which need alignment to induce regulatory acceptance of a 3R model. This paper displays that there are many similar mechanisms within both sectors that prevent 3R models from becoming accepted for regulatory risk assessment and management. Shared barriers include the uncertainty about the value of the new 3R models (micro level), the lack of harmonization of regulatory requirements and acceptance criteria (meso level) and the high levels of risk aversion (macro level). In optimizing the process commitment, communication, cooperation and coordination are identified as critical drivers. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Science, politics, and health in the brave new world of pharmaceutical carcinogenic risk assessment: technical progress or cycle of regulatory capture?

    Science.gov (United States)

    Abraham, John; Ballinger, Rachel

    2012-10-01

    The carcinogenicity (cancer-inducing potential) of pharmaceuticals is an important risk factor for health when considering whether thousands of patients on drug trials or millions/billions of consumers in the marketplace should be exposed to a new drug. Drawing on fieldwork involving over 50 interviews and documentary research spanning 2002-2010 in Europe and the US, and on regulatory capture theory, this article investigates how the techno-regulatory standards for carcinogenicity testing of pharmaceuticals have altered since 1998. It focuses on the replacement of long-term carcinogenicity tests in rodents (especially mice) with shorter-term tests involving genetically-engineered mice (GEM). Based on evidence regarding financial/organizational control, methodological design, and interpretation of the validation and application of these new GEM tests, it is argued that regulatory agencies permitted the drug industry to shape such validation and application in ways that prioritized commercial interests over the need to protect public health. Boundary-work enabling industry scientists to define some standards of public-health policy facilitated such capture. However, as the scientific credibility of GEM tests as tools to protect public health by screening out carcinogens became inescapably problematic, a regulatory resurgence, impelled by reputational concerns, exercised more control over industry's construction and use of the tests, The extensive problems with GEM tests as public-health protective regulatory science raises the spectre that alterations to pharmaceutical carcinogenicity-testing standards since the 1990s may have been boundary-work in which the political project of decreasing the chance that companies' products are defined as carcinogenic has masqueraded as techno-science. Copyright © 2012. Published by Elsevier Ltd.

  6. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  7. Regulatory authority of the Rocky Mountain states for low-level radioactive waste packaging and transportation

    International Nuclear Information System (INIS)

    Whitman, M.; Tate, P.

    1983-07-01

    The newly-formed Rocky Mountain Low-Level Radioactive Waste Compact is an interstate agreement for the management of low-level radioactive waste (LLW). Eligible members of the compact are Arizona, Colorado, Nevada, New Mexico, Utah, and Wyoming. Each state must ratify the compact within its legislature for the compact to become effective in that state and to make that state a full-fledged member of the compact. By so adopting the compact, each state agrees to the terms and conditions specified therein. Among those terms and conditions are provisions requiring each member state to adopt and enforce procedures requiring low-level waste shipments originating within its borders and destined for a regional facility to conform to packaging and transportation requirements and regulations. These procedures are to include periodic inspections of packaging and shipping practices, periodic inspections of waste containers while in the custody of carriers and appropriate enforcement actions for violations. To carry out this responsibility, each state must have an adequate statutory and regulatory inspection and enforcement authority to ensure the safe transportation of low-level radioactive waste. Three states in the compact region, Arizona, Utah and Wyoming, have incorporated the Department of Transportation regulations in their entirety, and have no published rules and regulations of their own. The other states in the compact, Colorado, Nevada and New Mexico all have separate rules and regulations that incorporate the DOT regulations. A brief description of the regulatory requirements of each state is presented

  8. Quality Management System at the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Novak, S.

    2008-01-01

    The process-oriented quality management system (QMS) implemented at the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in compliance with the EN ISO 9001:2001 standard is described. The history of the establishment and development of the QMS is given. The main, managerial and supporting processes with respect to defined activities are specified, and a scheme of their interactions is presented. The contents of the Quality Manual content and the structure of the system documentation are briefly described. The responsibilities for the operation and improvements of the QMS are described along with the methods applied (internal and external audits, self-assessment - Common Assessment Framework (CAF)). Examples of established quality objectives and indicators for some processes are provided. A future development of the QMS is expected in accordance with the relevant ISO Standard and IAEA recommendations and based on evaluation of the effectiveness of the critical system. (orig.)

  9. Criteria adopted by the Argentine Nuclear Regulatory Authority for assessing digital systems related to safety

    International Nuclear Information System (INIS)

    Terrado, Carlos A.; Chiossi, Carlos E.; Felizia, Eduardo R.; Roca, Jose L.; Sajaroff, Pedro M.

    2004-01-01

    Following the technological evolution in Instrumentation and Control (I and C) design, analog components are replaced by digital in almost every industry. Due to growing challenges of obsolescence and increasing maintenance costs, licensees of nuclear and radioactive installations are increasingly upgrading or replacing their existing I and C analog systems and components. In existing installations, this involves analog to digital replacements. In new installations design, the use of digital I and C systems is being considered from the very beginning, becoming a good alternative, even in safety applications. Up to now, in Argentina, there is no specific rules for safety-related digital systems, every safety system, analog or digital, must comply with the same generic regulations. The Nuclear Regulatory Authority is now developing criteria to assess digital systems related to safety in nuclear and radioactive installations. In this paper some of those criteria, based on local research and the recognized state of the art, are explained. From a regulatory point of view, the use of digital technology often raises new technical and licensing issues, particularly for safety-related applications. Examples include new failure modes, the potential for common-cause failure of redundant components, electromagnetic interference (EMI), software verification and validation, configuration management and a more exhaustive quality assurance system. The mentioned criteria comprehend the design, operation, maintenance and acquisition of digital systems and components important to safety. The main topics covered are: requirements specifications for digital systems, planning and documentation for digital system development, effectiveness of a digital system, commercial off the shelf (COTS) treatment and considerations involving tools for software development. (author)

  10. Development of infrastructure for the regulatory authority to implement risk-informed regulation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    It is important to assure the technical adequacy of probabilistic risk assessment (PRA) to implement risk-informed regulation of nuclear power plants (NPPs). JNES has been conducting various activities, such as development of PRA model, method, and data base, in order to assure the technical adequacy of PRA as development of the infrastructure for the regulatory authority to implement risk-informed regulation. In 2012, JNES updated the reliability data base used in PRA and improved PRA models to enhance the technical bases of PRA. In addition, JNES has been establishing the PRA model for fuel damage in the spent fuel storage pool in NPPs. As for improvement of PRA model for core damage in reactor, JNES conducted the study including feasibility of a simplified reliability model for digital I and C system developed by the digital I and C task group of OECD/NEA CSNI WGRISK by reproducing the sample calculation, and improvement of PRA models of individual NPPs in Japan. JNES is making effort to develop the procedures of internal fire PRA and internal flooding PRA. To improve the internal fire PRA, JNES is participating in OECD/NEA FIRE project to obtain the latest information and to validate and improve the fire propagation analysis codes and the parameters. JNES is establishing a method for analyzing internal influence due to flooding in NPPs, and this method is the base to develop the procedure of internal flooding PRA. (author)

  11. Participation of the Nuclear Regulatory Authority in the 'Third European Intercomparison Exercise on Internal Dose Assessment'

    International Nuclear Information System (INIS)

    Rojo, Ana Maria; Gomez Parada, Ines Maria

    2001-01-01

    This paper resume the participation of the Argentine Nuclear Regulatory Authority (ARN) in the 'Third European Intercomparison Exercise on Internal Dose Assessment'. It takes place during 5 months in 1998 and the final meeting was held in Weimar, Germany, on May 1999. This exercise involved the previous distribution of seven cases, simulated and real, describing possible incorporations of radioactive materials. There was a description of the event, data of retention or excretion measurements and air concentration data. The fifty participants belong to twenty three countries had do solve the cases and informed the results to the organizers, mainly the incorporation and effective dose was required. The objective was to review the methodology, the codes and the different assumptions used by the participants for discussing the consistent of the result. The results are shown through tables including the maximum and minimum values gave for the final report and the results informed by ARN. This exercise allowed to compare the methodology used by the ARN internal dosimetry group with other choose by several international groups to assure that the codes, assumptions and methodology were satisfactory to solve the different cases given by the organizers. (author)

  12. Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

    Energy Technology Data Exchange (ETDEWEB)

    Afzal, Muhammad [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-10-15

    The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

  13. Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

    International Nuclear Information System (INIS)

    Afzal, Muhammad; Choi, Kwang Sik

    2015-01-01

    The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

  14. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic and a subsequent partner IAEA IRRS mission

    International Nuclear Information System (INIS)

    Husarcek, Jan

    2012-01-01

    A self-assessment exercise performed by the Nuclear Regulatory Authority of the Slovak Republic based on the IAEA Integrated Regulatory Review Service (IRRS) methodology, and the follow-up IAEA mission are described. The self-assessment methodology is outlined. The purpose, scope, area, content and process of the self-assessment are explained. The work done, the summary results of the IAEA IRRS mission, and proposed improvements are described. (orig.)

  15. The nuclear regulatory authority of the Slovak Republic and start-up of the Mochovce NPP

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1999-01-01

    The important aspect is testing if the nuclear energy in the Slovak Republic is due to obligatory rules acceptable and its operation is regulated by the state through the independent institution - The Nuclear Regulatory Authority of the Slovak Republic (UJD). UJD considers the whole area of public relations an essential component of its activity. UJD intends to serve the public true, systematic, qualified, understandable and independent information regarding nuclear safety of nuclear power plants, as well as regarding methods and results of UJD work. Generally, public information is considered as significant contribution to the creation of confidence into the regulatory work. The public relations are understood as attempts to establish, keep and improve UJD-s good relations to its neighbours through purposeful informing. An Information centre at the offices of UJD was built and opened in October 1995 with IAEA Director General as the first visitor. NPP Mochovee is an example of international co-operation in achieving internationally acceptable safety standards. Companies from France, Germany, USA, Russian Federation, Czech Republic and Slovakia and last, but not least also the IAEA participated significantly on increasing the safety level of this NPP. We have been fully aware of the importance of good communication with press, TV and radio broadcasting in this pre-operation and operation period about nuclear safety, nuclear standard and other nuclear aspects commissioning of the NPP Mochovce in the UJD. The information policy of the UJD was in this period focused on the preparation an actual press releases for general and specialised news- paper and national press agencies. Very important were the frequent presentations the requirement safety stages of the NPP Mochovce inIV and radio broadcasting by headquarters of the UJD. UJD as the state authority provides information related to its competence, namely information on safety of operation of nuclear installations

  16. Methodological proposal for the construction of the labor profiles of inspectors of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Larcher, A.M.; Maceiras, E.; Degiovanni, G.; Perrin, C.; Sajaroff, P.

    2006-01-01

    The Argentine Nuclear Regulatory Authority (ARN) like essential part of their strategic institutional plan and in the mark of the modernization of the National Public Administration (NPA), identify the necessity to modify their functional organization, introducing the administration for processes and defining more flexible and better guided structures to the work in team. Starting from the definition of a new institutional flowchart it decided to proceed to a general reorganization of the human resources and on January, 2005 it was prepared the creation of a process whose serious objective to sit down the bases for the development of the professional career of the ARN. To such an end, it was thought about a work outline by stages, the first one of which had as final objective the elaboration of the Labor Profiles of the Institution. The work group for this first stage was integrated by a group of professionals of long trajectory in the institution and not belonging to the sector of Human Resources (RRHH). By this way it was organized as an independent group that it worked in narrow collaboration with the specific sector and informed directly to the maximum institutional direction. For the construction of the profiles a 'mixed' model was chosen that included the requirements of each position (that to make) and the competitions to complete them (how to make it), since a focus purely of competitions has not been seen as the more appropriate for the public administration and in particular for the ARN. In this work it is given to know a part of the results obtained during six months of effective work of the PerLa Group (denominated as well as an acronym of the expression Labor Profiles) putting emphasis in the defined profiles for the inspectors of those different regulatory branches that constitute the environment of competition of the RNA, this is Radiological Protection, Nuclear Safety, Safeguards and Physical Protection. The idea that underlies to the presentation

  17. Design and development of an informatics management system as a support for the Regulatory Authority in the Republic of Cuba

    International Nuclear Information System (INIS)

    Valdes Ramos, Maryzury; Prendes Alonso, Miguel; Jova Sed, Luis

    2008-01-01

    The regulatory activity in the country is carried out by the National Center for Nuclear Safety (CNSN) according to the international recommendations. To develop this, CNSN is supported by the Center for Radiation Protection and Hygiene (CPHR) which it's in charged of guaranteeing the technical scientific support for this activity. These centers have been working in the last years in the design and development of a computing tool that allows the management of all important information, which should be controlled by the Regulatory Authority. The authorization processes of the practices and the inspection program require the use, register and evaluation of an important volume of information that grows as the number of practices and facilities are increases. Consequently the systematizing of this information needs an automated management system. The objective of this work is to show the level of automation reached by the National Regulatory Authority using RASSYN program. This program allows an efficient management of the information related to the radiation sources nationwide, the practices ascribed to these sources, the personnel involved in these practices and the dose received, the equipment measuring and detecting of radiations, the generated waste, the occurred radiological incidents, the conditions and requisites of the granted authorizations and the results of the inspection program, among others. The possibilities of RASSYN system to process the information given by the users and the ones produced by the regulatory authority are described. The automatic generation of the annual inspections plan, according to the previously defined criteria and the system of alerts on the state of fulfillment of radiological protection requirements make RASSYN a useful tool to optimize the functioning of the regulatory system. The versatility of the statistical reports allows to guarantees not only the requirements of the regulatory authority but also the expectations coming

  18. Safety performance indicators used by the Russian Safety Regulatory Authority in its practical activities on nuclear power plant safety regulation

    International Nuclear Information System (INIS)

    Khazanov, A.L.

    2005-01-01

    The Sixth Department of the Nuclear, Industrial and Environmental Regulatory Authority of Russia, Scientific and Engineering Centre for Nuclear and Radiation Safety process, analyse and use the information on nuclear power plants (NPPs) operational experience or NPPs safety improvement. Safety performance indicators (SPIs), derived from processing of information on operational violations and analysis of annual NPP Safety Reports, are used as tools to determination of trends towards changing of characteristics of operational safety, to assess the effectiveness of corrective measures, to monitor and evaluate the current operational safety level of NPPs, to regulate NPP safety. This report includes a list of the basic SPIs, those used by the Russian safety regulatory authority in regulatory activity. Some of them are absent in list of IAEA-TECDOC-1141 ('Operational safety performance indicators for nuclear power plants'). (author)

  19. Actions of the Cuban Nuclear Regulatory Authority in the adequate implementation of the legislation in matter of radiological protection

    International Nuclear Information System (INIS)

    Fornet R, O.M.; Guillen C, A.; Betancourt H, L.A.

    2006-01-01

    The effectiveness of the regulatory activity in matter of safety and radiological protection it depends in great measure of the practical implementation level of the legislation in this matter. In our country this objective has been achieved through the one continuous improvement of the Hierarchical System of Nuclear Regulation, the reconciliation with specialists and national experts in each matter during the elaboration of the legal documents; the popularization and gratuitous distribution of it approved; the precision in the validation conditions of the authorizations of those main precepts applicable to the practices; the legal foundation of the deficiencies evidenced in the regulatory inspections; the development of a Safety Culture; the realization of Annual Regulatory Conferences and mainly in the training of the personnel related with the safety. Also, the constant analysis on the part of the specialists of the Regulatory Authority of the grade of implementation of this legislation, it discussion in national and international events and the actions recommended in these works. As a result of this focus, it is considered that the Regulatory Authority has impacted appropriately in the implementation of this legislation. (Author)

  20. The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, J.D.; Kleinschmidt, R.; Veevers, P. [Radiation Health, Queensland (Australia)

    1995-12-31

    Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safety of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.

  1. PHITS code improvements by Regulatory Standard and Research Department Secretariat of Nuclear Regulation Authority

    International Nuclear Information System (INIS)

    Goko, Shinji

    2017-01-01

    As for the safety analysis to be carried out when a nuclear power company applies for installation permission of facility or equipment, business license, design approval etc., the Regulatory Standard and Research Department Secretariat of Nuclear Regulation Authority continuously conducts safety research for the introduction of various technologies and their improvement in order to evaluate the adequacy of this safety analysis. In the field of the shielding analysis of nuclear fuel transportation materials, this group improved the code to make PHITS applicable to this field, and has been promoting the improvement as a tool used for regulations since FY2013. This paper introduced the history and progress of this safety research. PHITS 2.88, which is the latest version as of November 2016, was equipped with the automatic generation function of variance reduction parameters [T-WWG] etc., and developed as the tool equipped with many effective functions in practical application to nuclear power regulations. In addition, this group conducted the verification analysis against nuclear fuel packages, which showed a good agreement with the analysis by MCNP, which is extensively used worldwide and abundant in actual results. It also shows a relatively good agreement with the measured values, when considering differences in analysis and measurement. (A.O.)

  2. Substate federalism and fracking policies: does state regulatory authority trump local land use autonomy?

    Science.gov (United States)

    Davis, Charles

    2014-01-01

    State officials responsible for the regulation of hydraulic fracturing (fracking) operations used in the production of oil and gas resources will inevitably confront a key policy issue; that is, to what extent can statewide regulations be developed without reducing land use autonomy typically exercised by local officials? Most state regulators have historically recognized the economic importance of industry jobs and favor the adoption of uniform regulatory requirements even if these rules preempt local policymaking authority. Conversely, many local officials seek to preserve land use autonomy to provide a greater measure of protection for public health and environmental quality goals. This paper examines how public officials in three states-Colorado, Pennsylvania, and Texas-address the question of state control versus local autonomy through their efforts to shape fracking policy decisions. While local officials within Texas have succeeded in developing fracking ordinances with relatively little interference from state regulators, Colorado and Pennsylvania have adopted a tougher policy stance favoring the retention of preemptive oil and gas statutes. Key factors that account for between state differences in fracking policy decisions include the strength of home rule provisions, gubernatorial involvement, and the degree of local experience with industrial economic activities.

  3. Challenges in developing TSO to provide technical support in nuclear safety and security to Pakistan Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Mallick, Shahid A.; Sherwani, Uzman Habib; Mehdi, M. Ammar

    2010-01-01

    This paper highlights the needs for the establishment of a technical support organization (TSO) in Pakistan Nuclear Regulatory Authority (PNRA), challenges faced during its development, application of training need assessment required for the competency development of its technical manpower and difficulties encountered after its evolution. Key issues addressed include recruitment of technical manpower and enhancing their competencies, acquisition of proper tools required for safety review and assessment, development of a sustainable education and training program consistent with the best international practices and taking the measures to get confidence of the regulatory body. (author)

  4. An epidemiological analysis of equine welfare data from regulatory inspections by the official competent authorities.

    Science.gov (United States)

    Hitchens, P L; Hultgren, J; Frössling, J; Emanuelson, U; Keeling, L J

    2017-07-01

    welfare if they also complied with documentation requirements. We present a novel approach for analysis of equine welfare data from regulatory inspections by the official competent authorities, and propose on-going analyses and benchmarking of trends in animal-based measures over time. We also suggest how such a database could be further improved to facilitate future epidemiological analyses of risk factors associated with poor equine welfare. The study has implications for other competent authorities and researchers collaborating in the area of animal welfare epidemiology.

  5. The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

    Science.gov (United States)

    de Wilde, Sofieke; de Jong, Maria G H; Lipka, Alexander F; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

    2018-03-01

    Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to

  6. Use of probabilistic safety assessment in supporting regulatory authority`s work; Todennaekoeisyyspohjaisen turvallisuusanalyysin kaeyttoe viranomaistyoen tukena

    Energy Technology Data Exchange (ETDEWEB)

    Julin, A

    1995-11-01

    The aim of the study was to examine possibilities to use probabilistic safety assessment (PSA) more effectively in regulatory control of nuclear power plants. The structure, results and evaluation methods of PSA along with the necessary equations and principles, which could be used in utilising level 1 PSA results in decision making, have been introduced. The presented examples describe the ways PSA has been utilised abroad and particularly in Finnish Centre for Radiation and Nuclear Safety (STUK). The examples calculated in the study are based on the SPSA code and the PSA model of Olkiluoto nuclear power plant (TVO). The examples compare component safety classes versus safety importance and the risk of continued operation versus shutdown alternative in residual heat removal system failures. In addition to this allowed outage times, as calculated by PSA, were compared to allowed outage times according to technical specifications. The last 9 years operating experiences of TVO II was also examined by analysing the risk importance of significant component failures and operational disturbances. The analysis showed that the contribution of component failures and operational disturbances to the overall core damage risk during the studied time period was only 5 per cent. It appeared that the rare, significant initiating events provide the main contribution to the total cumulative risk. (57 refs., 22 figs., 17 tabs.).

  7. EU Activities for Training and Tutoring of Nuclear Regulatory Authorities and Technical Support Organisations Outside EU

    International Nuclear Information System (INIS)

    Pauwels, Henri; Daures, Pascal; Stockmann, Ynte

    2014-01-01

    Aim of Training and Tutoring Projects: Transfer of European Union nuclear safety regulatory experience and best practices. The following courses are listed: Courses in Nuclear Safety Regulation, Licensing and Enforcement; Nuclear Safety Assessment and Inspection

  8. 25 CFR 547.4 - How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation...

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation comply with this part? 547.4 Section 547.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM TECHNICAL STANDARDS FOR GAMING...

  9. The functions and organization of the regulatory authority for nuclear energy in Turkey

    International Nuclear Information System (INIS)

    Aybers, Nejat

    1979-01-01

    Following a description of the legislative and regulatory provisions governing nuclear activities in Turkey, this paper analyses the licensing system for nuclear installations. Special emphasis is placed on the problems of setting up a nuclear power plant project in a developing country and on the need for codes of practice on safe design and operation of such plants at the national level. (NEA) [fr

  10. 47 CFR 1.1151 - Authority to prescribe and collect regulatory fees.

    Science.gov (United States)

    2010-10-01

    ... regulatory activities in the private radio, mass media, common carrier, and cable television services. [59 FR... fees. 1.1151 Section 1.1151 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... section 9 of the Communications Act, 47 U.S.C. 159, which directs the Commission to prescribe and collect...

  11. Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 46/2006 Coll. on specific material and facilities that are under supervision of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Vaclav, J.

    2006-01-01

    The Public Notice defines the list of specific material and facilities which are under supervision of the Nuclear Regulatory Authority of the Slovak Republic with taking into consideration the requirements in accordance with the new atomic Act and other material. The national competence's have been practically divided in the Public Notice. These competence's concern the execution of directly binding EU rule and the Public Notice gives the details about the dividing of specific materials

  12. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

  13. [The Working Group of Enforcement Officers (WGEO) : The European Network of Drug Regulatory Authorities to Combat Pharmaceutical Crime].

    Science.gov (United States)

    Wittstock, Marcus; Streit, Renz

    2017-11-01

    Ten years ago the Heads of Medicines Agencies (HMA) officially founded the Working Group of Enforcement Officers (WGEO), a European working group to reduce falsifications of human and veterinarian medicinal products in the legal and illegal supply chain. Police, customs and other international organisations are also represented in the WGEO. Partner organisations are for example the Directorate General for Health and Food Safety of the European Commission, the European Medicines Agency (EMA), the European Police Office (Europol), the International Criminal Police Organization (Interpol), the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO). The main goal of the group is the protection of public health from harmful medicines for both humans and animals. The WGEO has created a network of its members and a rapid alert system to exchange confidential information on falsified or stolen medicinal products. There are face-to-face meetings twice a year including training using case studies.

  14. Role of the regulatory authority in preparation of the NPP self assessment of safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Gantchev, T [Committee on the Use of Atomic Energy for Peaceful Purposes, Sofia (Bulgaria)

    1997-12-31

    We believe that with the assistance of the IAEA(ASSET Training Mission) the plant personnel will be able to prepare high quality Self Assessment Report. The main role of the Regulatory Body is to ensure correspondence with the IAEA requirements and to provide clear guidance for the most important items of the Plant Self Assessment Report. The involvement of the Operating Organization is also desirable in order to ensure the necessary resources for the implementation of the action plan. Figs.

  15. Role of the regulatory authority in preparation of the NPP self assessment of safety culture

    International Nuclear Information System (INIS)

    Gantchev, T.

    1996-01-01

    We believe that with the assistance of the IAEA(ASSET Training Mission) the plant personnel will be able to prepare high quality Self Assessment Report. The main role of the Regulatory Body is to ensure correspondence with the IAEA requirements and to provide clear guidance for the most important items of the Plant Self Assessment Report. The involvement of the Operating Organization is also desirable in order to ensure the necessary resources for the implementation of the action plan. Figs

  16. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  17. Pharmaceutical regulation in 15 European countries review.

    Science.gov (United States)

    Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

    2016-10-01

    In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

  18. Nuclear Regulatory Commission authorizations for Fiscal Years 1984 and 1985. House of Representatives, Ninety-Eighth Congress, First Session

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    H.R. 2510, as amended, authorizes $466.8 million to cover Nuclear Regulatory Commission salaries and expenses for fiscal year 1984 and $460 million for the following year in a two-year authorization. The bill substitutes certain expenditures for those recommended in the NRC request, while keeping the funding level the same. The committee report reviews and summarizes the two-year budget appropriation and the hearings before giving a section-by-section analysis. It notes that 46% is earmarked for waste management, and emphasizes the safety factors which have caused delays in construction and modifications in existing plants. 13 tables

  19. Technical and scientific support to nuclear regulatory authority in Montenegro. Present situation and outlooks for the future

    International Nuclear Information System (INIS)

    Jovanovic, S.

    2007-01-01

    Nuclear regulatory competences in the Republic of Montenegro are shared between the ministries of health and of the environment. Following the independence of the country by mid 2006, Radiation Protection Commission (RPC) is established within the Ministry of Health, so as to match the regulatory role for the sources used in medicine. A similar step is expected to be made soon within the Ministry of the Environment, too. The two commissions will likely and logically merge into one, representing an interim regulatory authority to be functioning until a full capacity and effectively independent regulatory body is established by new nuclear law. Promulgation of the latter is expected to take part in the course of 2007. Let us mention here that the law in force is one from 1996 - quite obsolete and not taking into consideration the Basic Safety Standards (IAEA, 1996) and subsequent IAEA and EU documents in the field. Montenegro is a small, non-nuclear country (no nuclear installations or fuel cycle segments), the use of radiation sources being limited mostly to medical and industrial applications. Technical support to regulatory functions, in whatever basic form these were effectuated up to now, was/is given by the Centre for Eco-Toxicological Research of Montenegro (CETI), Department of Radiation Protection and Monitoring, in Podgorica. As to scientific support, it is fundamentally to be found at the University of Montenegro, Faculty of Sciences (FS), Department of Physics. While CETI is relatively well equipped, running quite a modern nuclear spectrometry laboratory (alpha, beta and gamma spectrometry, radon measurements) and having a decent dosimetry unit (TLD, field and workplace monitoring), FS is practically limited to sporadic theoretical studies, with very poor laboratory capabilities. Environmental radioactivity monitoring is performed by CETI, following the programme defined by the government. Licensing and inspections are the two regulatory functions still

  20. Strategies for patient empowerment through the promotion of medicines in Israel: regulatory framework for the pharmaceutical industry.

    Science.gov (United States)

    Schwartzberg, Eyal; Barnett-Itzhaki, Zohar; Grotto, Itamar; Marom, Eli

    2017-09-29

    The correct and rational use of medications can have a positive direct impact on disease outcomes, as well on the utilization of the health system resources. Unfortunately, 50% of the patients do not take their medications as prescribed, largely due to lack of patients' understanding of their medical condition, as well as the lack of reliable medicine information.There are multiple strategies implemented in many countries to tackle this challenge including: disease awareness campaigns (DAC) to raise the public awareness to specific diseases, direct-to-consumer advertisement (DTCA) to raise the public awareness to prescription medicines, specific treatments and over-the-counter (OTC) products to improve the accessibility of patients to specific medicines.Prior to 2013, the Israeli policy prohibited prescribing medication advertising and prevented the flow of information from pharmaceutical companies to the patient. In the last five years, the Pharmaceutical division in the Israeli Ministry of Health, as part of the "empowering the patient" agenda, has taken new innovative approaches to raise public awareness to diseases, medications and appropriate usage, as well as promotion of information to improve patient adherence to the prescribed medication.This paper elaborates on the aforementioned strategies implemented in developed countries, and specifically focuses on newly implemented strategies and regulations in Israel regarding pre- and post-prescription information, to improve patient appropriate utilization and adherence to medication.

  1. Combating corruption in the pharmaceutical arena.

    Science.gov (United States)

    Lexchin, Joel; Kohler, Jillian Clare; Gagnon, Marc André; Crombie, James; Thacker, Paul; Shnier, Adrienne

    2018-03-15

    Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

  2. Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps.

    Science.gov (United States)

    Okudaira, Noriko

    2017-09-01

    This article discusses the evaluation of drug candidates as hepatic transporter substrates. Recently, research on the applications of hepatic transporters in the pharmaceutical industry has improved to meet the requirements of the regulatory guidelines for the evaluation of drug interactions. To identify the risk of transporter-mediated drug-drug interactions at an early stage of drug development, we used a strategy of reviewing the in vivo animal pharmacokinetics and tissue distribution data obtained in the discovery stage together with the in vitro data obtained for regulatory submission. In the context of nonclinical evaluation of new chemical entities as medicines, we believe that transporter studies are emerging as a key strategy to predict their pharmacological and toxicological effects. In combination with the recent progress in systems approaches, the estimation of effective concentrations in the target tissues, by using mathematical models to describe the transporter-mediated distribution and elimination, has enabled us to identify promising compounds for clinical development at the discovery stage. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  3. Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

    Directory of Open Access Journals (Sweden)

    Roïz Julie

    2014-11-01

    Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

  4. Authorization of radioactive waste disposal under RSA93: regulatory experience and developments

    International Nuclear Information System (INIS)

    McHugh, J.O.

    1997-01-01

    The Environment Agency was formed in 1996 and is responsible for regulating radioactive waste disposal in England and Wales. In determining applications for disposal authorizations, it consults other statutory bodies including the Ministry of Agriculture, Fisheries and Food and the Health and Safety Executive. The Agency has published updated guidance on the principles and requirements for authorization of geological disposal of low and intermediate level waste. It will apply a risk target of 10 -6 per year in determining authorizations for waste disposal. Further work is required to elaborate the concept of 'critical group' to which the risk target should be applied. The Agency has also considered amending the methodology it uses for regulation of radioactive waste discharges from nuclear installations. Concerns expressed by the nuclear industry about the lack of operational flexibility in discharge authorizations, led the Agency to develop an alternative method of regulation. Responses to this initiative were mixed. In the future, the Department of the Environment will be reviewing the principles underpinning regulation of discharges, with the intention of setting out guidance on the objectives to be achieved and factors to be taken into account. (author)

  5. Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients

    DEFF Research Database (Denmark)

    Malwade, Chandrakant Ramkrishna; Qu, Haiyan

    2018-01-01

    Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing of Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities...... parameters and their impact on quality of APIs and subsequently the drug products assume great significance for pharmaceutical industry. Methods: This review paper focuses on application of PAT tools, an integral part of Quality by Design (QbD) approach, for better understanding, control, and design...

  6. Argentina Nuclear Regulatory Authority and the final disposition gives to radioactive wastes

    International Nuclear Information System (INIS)

    Petraits, E.; Siraky, G.; Novo, R.

    1998-01-01

    This work describes the alignment legislative and regulator in which is carried out the final disposition the radioactive wastes in the Argentina Republic . Timbers the activities are presented the Authority Nuclear Regulator (RNA) and the applied focuses in connection with the inspections to the facilities, the evaluations security the associate systems and the collaboration with the international organizations in this matter

  7. Constraining Government Regulatory Authority: Tobacco Industry Trade Threats and Challenges to Cigarette Package Health Warning Labels

    OpenAIRE

    Crosbie, Eric

    2016-01-01

    This dissertation investigates the rising authority of non-state actors vis-à-vis the state by examining how tobacco companies are using trade agreements to constrain governments from implementing progressive public health policies that require placing pictorial health warning labels (HWLs) on cigarette packages. In particular, the dissertation seeks to address two different but related puzzles. First, despite being developed countries and global health leaders, it is unclear why Australia ha...

  8. Management by regulatory inspection authorities of experience gained from safety related occurrences in nuclear power plants

    International Nuclear Information System (INIS)

    Tore, E.; Nilsson, R.

    1977-01-01

    A short description is given of the system used by the Swedish Nuclear Power Inspectorate to collect information of events occurring in nuclear power plants. The standard forms used by the utilities when reporting the events are described and a motivation given to their lay-out. The evaluation routine is defined and statistics given of events which occurred during the period July 1 1974 to December 31 1976. (author)

  9. Common market but divergent regulatory practices: exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products

    NARCIS (Netherlands)

    Chowdhury, Nupur

    2013-01-01

    The medical product sector is characterised by a regulatory patchwork of European and national laws and guidelines operating concurrently with each other. Each of these sectors are characterised by different levels of regulatory uncertainty that may undermine the effectiveness of the regulatory

  10. Health risks of counterfeit pharmaceuticals.

    Science.gov (United States)

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

  11. Crisis communication in conditions of the Nuclear Regulatory Authority of Slovak Republic

    International Nuclear Information System (INIS)

    Seliga, M.

    2004-01-01

    Emergency planning shall mean a set of measures and procedures to identify and bring under control incidents and accidents at nuclear installations and to identify, mitigate and eliminate consequences of releases of radioactive substances into the environment. Emergency preparedness shall mean the capability to develop and realize activities and measures which lead to identification and effective elimination of incidents and accidents as well as to suppression of risks of threats to life, health or assets of population and environment. The acquisition of practical experience from emergency exercises, the approach to decision making in the late phase of the accident and pieces of information on communication with media were the most important. (author)

  12. The regulatory authorities` perspective of environmental impact assessment (EIA). Report of the Joint Working Group

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [Swedish Nuclear Power Inspectorate, Stockholm (Sweden); Haegg, C. [Swedish Radiation Protection Inst., Stockholm (Sweden); Larsen, B. [Boverket, Stockholm (Sweden); Loefgren, T. [Lund Univ. (Sweden); Schibbye, K. [Riksantikvarieaembetet, Stockholm (Sweden); Timm, B. [Swedish Environmental Protection Agency, Solna (Sweden)

    1995-12-01

    The present paper is a highly abridged version of the report SSI--95-05 (available in Swedish only). The report mainly deals with the broad basis for decision-making which is necessary for licensing by the government in accordance with section 4 of the Act (1987:12) concerning the Management of Natural Resources etc (Natural Resources Act) for the siting of facilities for the final disposal of spent nuclear fuel that is planned in Sweden. Licensing issues which currently are of interest concern decisions on the siting of an encapsulation facility and detailed characterization of potential sites for a repository. Several governmental authorities will be involved in these licensing issues. Furthermore, it is noted that decisions regarding the different facilities will be made in several stages e g feasibility studies, site investigations, detailed characterizations, siting, construction and commissioning. The joint group issued recommendations with regard to the content of the EIS and how the EIA should be worked out.

  13. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

    Science.gov (United States)

    Enzmann, Harald; Broich, Karl

    2013-01-01

    For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

  14. Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

    Science.gov (United States)

    Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.

  15. The comprehensive registration and information system of radiation protection regulatory authority in the Czech Republic

    International Nuclear Information System (INIS)

    Petrova, K.

    2004-01-01

    and control in radiation protection. (Author) 6 refs

  16. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2011

    International Nuclear Information System (INIS)

    2012-05-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2011 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Nuclear materials and physical protection of nuclear materials; (6) Scope of powers of the office building; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) UJD SR organization chart; The International Nuclear Event Scale (INES); (12) Abbreviations.

  17. Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

    Directory of Open Access Journals (Sweden)

    Freeman Michael

    2012-03-01

    Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

  18. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    International Nuclear Information System (INIS)

    Mladineo, S.; Frazar, S.; Kurzrok, A.; Martikka, E.; Hack, T.; Wiander, T.

    2013-01-01

    In November 2012 the International Atomic Energy Agency (IAEA) sponsored a Technical Meeting on the Interfaces and Synergies in Safety, Security, and Safeguards for the Development of a Nuclear Power Program. The goal of the meeting was to explore whether and how safeguards, safety, and security systems could be coordinated or integrated to support more effective and efficient nonproliferation infrastructures. While no clear consensus emerged, participants identified practical challenges to and opportunities for integrating the three disciplines’ regulations and implementation activities. Simultaneously, participants also recognized that independent implementation of safeguards, safety, and security systems may be more effective or efficient at times. This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation either with a newcomer State, or to a State with a fully developed SRA.

  19. Preservation of primary information related to radiological protection and nuclear safety in the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin

    2008-01-01

    The preservation of primary information related to Radiological Protection and Nuclear Safety in the Argentine Nuclear Regulatory Authority began as a need of and as significant contribution to the future activities of the institution. Since 2005 a high number of experts have retired from the organization and will continue to do so until 2010. Besides, the primary information that experts possess is technical information produced at the beginning of Argentina's regulatory activity in the 50 's. If this information on account of its relevance - could not be preserved properly or be made available to the future generation of scientists and technicians, such an issue could have a negative impact on the efficiency and effectiveness of the institution in the future. The methodology selected for the project comprises several stages. Overall, the first stage consists in identifying primary information and expert's explicit knowledge through interviews and personal consultations. The second stage consists in converting to digital format the documentation that experts have traditionally kept in paper format. The third stage deals with transferring to a new database the already digitalized information from the computers of experts who are about to retire. The final stage is based on managing this information by creating knowledge maps and socio-grams, experts personal Web sites and a database with a mega browser to make information readily accessible. During the early months of the project, 190 pages have on average been converted to digital format on a daily basis, the equivalent of around 8 MB of information. The men/hours employed for this task has been around 40 minutes per day. As time went by, the method turned more efficient and as a result, some 400 pages were converted to digital format on a daily basis, accounting for 16 MB of information. The men/hours employed for this task has been around 60 minutes per day. Up until mid 2008, more than 1,000 documents have been

  20. Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 52/2006 Coll. on professional competence

    International Nuclear Information System (INIS)

    Szabo, V.

    2006-01-01

    The Public Notice has replaced the previous Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 187/1999 Coll. on Professional competence of employees of nuclear power facilities. The new experience acquired in area of Professional preparation of employees holders of permissions has been included into the Public Notice as well as acknowledged principles of verification of the Professional competence and specific Professional competence of employees holders of permissions. There are rights and duties of permission holders elaborated in the Public Notice where the employees have an influence to the nuclear safety (professionally competent employees of permission holders) or have the direct influence to the nuclear safety (selected employees of permission holders). The Public Notice has also modified the details about preparation of employees of the operator of specific facilities who carry out the professional preparation of the employees holders of permissions

  1. Knowledge management in the Argentine Nuclear Regulatory Authority; La gestion del conocimiento en la Autoridad Regulatoria Nuclear Argentina

    Energy Technology Data Exchange (ETDEWEB)

    Chahab, Martin [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)

    2006-07-01

    In 2006, the Argentine Nuclear Regulatory Authority has initiated a regulatory knowledge management process to face the loss of knowledge resulting from retiring experts, the generation gap, and the existing need to train new human resources. A number of projects have been started together with the technical assistance of the National Public Administration Institute to preserve knowledge and render it explicit for the coming generations. These projects include 'The History of the Expert's Learning Process' in which the majority of the most critical experts have been interviewed so far. The results of this project help envision a training structure and prospective projects. An Internet Site has also been created on the Intranet in order to render knowledge explicit and facilitate the tools for knowledge management initiatives. Furthermore, ARN's knowledge map project has also been started. (author) [Spanish] La Autoridad Regulatoria Nuclear (ARN), es un Organismo Autarquico de la Administracion Publica Nacional de la Republica Argentina. La puesta en marcha de la gestion del conocimiento en este Organismo responde a la necesidad de no perder los conocimientos de la institucion en el marco del problema del retiro de un numero importante de expertos y de la falta de transmision de sus conocimientos a la nueva generacion. Esta actividad se pone en marcha a traves de programas especificos como entrevistas a expertos retirados y en actividad, la confeccion de un mapa del conocimiento, la identificacion de los conocimientos tacitos y explicitos para su transmision intergeneracional, entre otros, e implica supeditar la estructura tradicional y los procedimientos ya establecidos a los resultados de la misma para cumplir con la mision y vision institucional. Se presentan los objetivos y las caracteristicas del Plan Estrategico de la Institucion, los resultados hasta ahora alcanzados y los desafios a afrontar. (autor)

  2. [E-commerce of pharmaceuticals].

    Science.gov (United States)

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

  3. Why regulatory indifference towards pharmaceutical pollution of the environment could be a missed opportunity in public health protection. a holistic view.

    Science.gov (United States)

    Kamba, Pakoyo Fadhiru; Kaggwa, Bruhan; Munanura, Edson Ireeta; Okurut, Tom; Kitutu, Freddy Eric

    2017-01-01

    The last generation has witnessed bludgeoning of the world's population, a spike in disease burden, and unprecedented levels of pharmaceutical consumption and production. Unfortunately, pharmaceuticals have left their industrial and household confines and leaked into the environment. Pharmaceuticals are now major environmental pollutants, and are ubiquitous in waters and soils. Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from drug-drug interactions, exacerbation of drug resistance, and reduction in aquatic and terrestrial food production. Therefore, ignoring pharmaceutical pollutants deprives society of holistic public health protection.

  4. The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.

    Science.gov (United States)

    Risha, Peter Gasper; Msuya, Zera; Clark, Malcolm; Johnson, Keith; Ndomondo-Sigonda, Margareth; Layloff, Thomas

    2008-08-01

    The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

  5. Reflections on the role of the pharmacy regulatory authority in enhancing quality related event reporting in community pharmacies.

    Science.gov (United States)

    Boyle, Todd A; Bishop, Andrea C; Mahaffey, Thomas; Mackinnon, Neil J; Ashcroft, Darren M; Zwicker, Bev; Reid, Carolyn

    2014-01-01

    Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice. This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles. A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict

  6. REFLECTIONS ON THE ROLE OF THE PHARMACY REGULATORY AUTHORITY IN ENHANCING QUALITY RELATED EVENT REPORTING IN COMMUNITY PHARMACIESi

    Science.gov (United States)

    Boyle, Todd A.; Bishop, Andrea C.; Mahaffey, Thomas; MacKinnon, Neil J.; Ashcroft, Darren; Zwicker, Bev; Reid, Carolyn

    2016-01-01

    Background Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice Objective This study aims to better understand the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies and identifying regulatory best practices to execute such roles. Methods A purposive case sampling approach was used to identify PRA staff members from two groups (deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Results Two focus groups were conducted, one with seven deputy registrars/practice managers and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Conclusions Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may

  7. Data Bank of Nuclear and Radiological Regulatory Authority, Part 2 . Software Package of Statistical Data of Sealed Sources

    International Nuclear Information System (INIS)

    Lashin, R.M.A.; Mahmoud, N.S.; Lashin, M.M.A.

    2012-01-01

    Protection of human, property and the environment is the main concern considered as a principal goal to form the Egyptian Nuclear and Radiological Regulatory Authority. That requires a lot of work, efforts, knowledge and aids for right and quick decision making. Internationally, the International Atomic Energy Agency (IAEA) developed a protection system for control and accounts the radioactive materials for the safe use and transport. Moreover, the protection system can prevent the theft of these materials or their use in terrorism. Here in, all radioactive sources shall be subjected to instructions, serious regulations and laws. In order to exercise these functions, it is necessary to accurately establish the appropriate information system to the regulatory body. This system must depend on using a modern technology to perform the work in most accurate and fullest manner in a Data Bank [1, 2]. The present work is the second part performed for the data bank, which consists of two parts: first part is concern about the open sources which executed before [3]. Second part is deal with the sealed sources. Describing here consolidated guidance help materials licenses. It also provides reviewers of such requests with the information and materials necessary to determine that the products are acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

  8. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2007. Annual report

    International Nuclear Information System (INIS)

    2007-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2007 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) Abbreviations

  9. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2010

    International Nuclear Information System (INIS)

    2010-05-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2010 is presented. These activities are reported under the headings: Address of the Chairperson; (1) Legislative activities; (2) Issuance of authorizations, assessment, supervisory activities and enforcement; (3) Nuclear safety of nuclear power plants; (4) Nuclear materials and physical protection of nuclear materials; (5) Powers of the office building; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Appendix: UJD SR organization chart; The International Nuclear Event Scale (INES); Abbreviations.

  10. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2009. Annual report

    International Nuclear Information System (INIS)

    2010-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2009 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations.

  11. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2008. Annual report

    International Nuclear Information System (INIS)

    Zemanova, D.; Pirozekova, M.

    2009-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2008 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Activity of Building Office; (9) Emergency planning and preparedness; (10) International activities; (11) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations

  12. Adaptation of regulatory information and knowledge through knowledge maps in the Argentine Nuclear Regulatory Authority within the framework of nuclear renaissance

    International Nuclear Information System (INIS)

    Chahab, Martin; Dawyd, Noelia

    2008-01-01

    almost immediate search for information for organizational decision-making purposes. Finally, knowledge maps contribute new specialist-centered or subject-specific information to libraries. Knowledge maps show a universe of information and knowledge in a summarized and orderly manner, helping the institution work more effectively and efficiently. As an example of the proposition, a map of one of the topics carried out at the Argentine Nuclear Regulatory Authority is illustrated. (author)

  13. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  14. Does brand differentiate pharmaceuticals?

    Science.gov (United States)

    Bednarik, Josef

    2005-12-01

    Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

  15. The role of national regulatory authority in monitoring of radioactivity and in case of seizure of radioactive or nuclear material

    International Nuclear Information System (INIS)

    Morkunas, G.

    2002-01-01

    Full text: The Radiation Protection Centre is a regulatory authority in radiation protection in Lithuania. Its main tasks are licensing of practices, supervision, control and enforcement of radiation protection requirements, dosimetric, radiometric and spectrometric measurements, evaluation of exposure and its sources, expertise and advice on optimization of radiation protection. Its activities may be divided into two main parts -- regulatory and analytical ones. Food, drinking water, environmental, wipe and other samples are monitored, the appropriate evaluation of doses is done. The data on concentrations of artificial radionuclides in different bodies are available. The laboratory is to be accredited according to the ISO 17025 standard in the framework of Phare Twinning Project. In case of seized radioactive or nuclear material the Radiation Protection Centre has to identify the necessary radiation protection means for members of public and emergency workers, perform measurements of dose rate and radioactive contamination, and, if necessary, evaluate doses received due to the seized radioactive or nuclear material. Since the Radiation Protection Centre has its departments in the largest cities of Lithuania the above mentioned measures can be taken very urgently, especially the ones connected with primary evaluation of situation and identification of optimized radiation protection measures. The Radiation Protection Centre has its own possibilities of identification of radionuclides in the seized material. Such installations as HpGe spectrometers (Oxford and Canberra), equipment for radiochemical separation of U, Pu and actinides, alpha spectrometer, liquid scintillation spectrometer and neutron rem counter are available. There were a few cases when seized material had to be analyzed also. Different sources were found in different places of Lithuania, and it was necessary to define the activity and isotopic content of these sources. The following scheme is used in

  16. Efficiency of the low energy detection system for the measurement of 235 U in lung of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Spinella, M.R.; Krimer, M.; Gregori, B.N.; Rojo, A.M.

    2006-01-01

    This work presents the results of the calibration process of the detection system of 235 U in lung of the Nuclear Regulatory Authority. The phantom used in the calibration is the denominated Lawrence Livermore Realistic Phantom, provided of lungs and active nodules and of 4 thoracic covers that its simulate muscular tissue with thickness that vary between 1.638 and 3.871 cm. The spectra are acquired by four detecting of denominated LEGe ACTII Canberra marks, each one with an active area of 3800 mm 2 , a diameter of 70 mm and a thickness of 20 mm, the sign is processed by a SYSTEM100 multichannel and the spectra are analyzed with the GENIE2K program. The detectors are suspended by mobile structures that allow to vary the position with regard to a horizontal stretcher that defines the measurement geometry. The whole system is located in the interior of an armored enclosure of 200 x 150 x 200 cm 3 of steel of 15 cm thickness, inside recovered with layers of 0.5 cm lead and 0.05 cm cadmium. The total weight of the enclosure is 40 ton. For the described system the efficiency curves versus muscular thoracic tissue thickness (ETM) corresponding to the energy of 143.76, 163.358 and 185.72 keV of the 235 U radioisotope were obtained. Its were also practiced displacements of those detectors of approximately 1 cm with respect to the reference position and its were analyzed the corresponding changes of magnitude in the efficiencies. The obtained variations oscillate, for vertical displacements, between 5% and 7.8% for the smallest value in ETM (1.638 cm) and between 4.2% to 6.7% for the ETM 3.871 cm. While for the practiced lateral displacements, the variations go from 4% to 15%. The detection limits corresponding to each energy and thickness were determined. The results showed for the photopeak of 185.72 keV, the more outstanding in the evaluations that saying limit it oscillates between 3.7 and 6.4 Bq 235 U inside the considered thickness range. (Author)

  17. Communication Received from the Permanent Mission of Pakistan to the International Atomic Energy Agency Concerning the Promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001

    International Nuclear Information System (INIS)

    2001-01-01

    The Director General has received a communication dated 30 January 2001 from the Permanent Mission of Pakistan forwarding a press release concerning the promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001. As requested in that communication, the press release is attached hereto for the information of Member States

  18. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-08-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately.

  19. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    International Nuclear Information System (INIS)

    2001-01-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately

  20. WHO expert committee on specifications for pharmaceutical preparations.

    Science.gov (United States)

    2013-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

  1. Amendment to the Decree of the Slovak Nuclear Regulatory Authority on details concerning emergency planning in case of nuclear incident or accident

    International Nuclear Information System (INIS)

    Biharyová, Michaela

    2018-01-01

    Following up amendment to the Slovak Atomic Act, the Decree No. 55/2006 on details concerning emergency planning in case of nuclear incident or accident has also been amended now. Following a short introductory text by the author, the entire text of the ‘Decree of the Nuclear Regulatory Authority of the Slovak Republic No 9/2018 Coll. of 2 January 2018 amending Decree of the Nuclear Regulatory Authority of the Slovak Republic No 55/2006 Coll. on details in emergency planning in case of nuclear incident or accident as amended by Decree No. 35/2012 Coll.’ is reproduced. The Amendment entered into force 1 February 2018. (orig.)

  2. Restoring trust in the pharmaceutical sector on the basis of the SSRI case

    NARCIS (Netherlands)

    Hernandez, Juan Francisco; van Thiel, Ghislaine J. M. W.; Mantel-Teeuwisse, Aukje K.; Raaijmakers, Jan A. M.; Pieters, Toine

    The lack of public trust in the pharmaceutical sector (i.e. industry, authorities and doctors) could compromise the future of drug development and the regulatory system. Public trust integrates two important components, namely the vulnerability of the truster and the competence of the trustee.

  3. Restoring trust in the pharmaceutical sector on the basis of the SSRI case

    NARCIS (Netherlands)

    Hernandez, J.F.; van Thiel, G.J.M.W.; Mantel-Teeuwisse, A.K.; Raaijmakers, J.A.M.; Pieters, T.

    2014-01-01

    The lack of public trust in the pharmaceutical sector (i.e. industry, authorities and doctors) could compromise the future of drug development and the regulatory system. Public trust integrates two important components, namely the vulnerability of the truster and the competence of the trustee.

  4. The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis

    International Nuclear Information System (INIS)

    Nishijima, Kazumi; Katsuya, Yoshio

    2002-01-01

    The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)

  5. 75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-11

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...

  6. Regulation of Federal radioactive waste activities. Summary of report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

    International Nuclear Information System (INIS)

    Smith, R.D.

    1979-09-01

    The NRC Authorization Bill for FY 1979 directed NRC to conduct a study of extending the Commission's licensing or regulatory authority to include categories of existing and future Federal radioactive waste storage and disposal activities not presently subject to such authority. The report includes a complete listing and inventory of all radioactive waste storage and disposal activities now being conducted or planned by Federal agencies. The NRC study has attempted to present a general comparison of the relative hazards associated with defense-generated and commercial wastes. Options for extending Commission authority were developed and analyzed. The implications of NEPA were analyzed in the context of these options. The national security implications of extending NRC's regulatory authority over DOE programs are examined and evaluated. Costs and benefits are identified and assessed. The Commission's recommendations, based on the study, are to extend licensing authority over new DOE disposal activities involving transuranic wastes and non-defense low-level waste and to initiate a pilot program to test the feasibility of NRC playing a consultative role in the evaluation of existing DOE activities

  7. Facility specialists and inspectorate staff of the nuclear regulatory authority training in the field of management systems in compliance with the latest IAEA standards

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.; Filimonov, G.

    2007-01-01

    A problem of reducing a human factor negative influence reduction upon nuclear safety should be solved on the whole at the expense of introducing integrated management systems with a comprehensive application of regulatory control, training and inspections. This paper covers FSUE VO Safety and Training and Methodical Center of Nuclear and Radiation Safety approach towards training matters, which is one of the key factors in implementing quality and safety management systems. (author)

  8. [Pharmaceutical product quality control and good manufacturing practices].

    Science.gov (United States)

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

  9. The National Radiation Protection Authority and its regulatory programme. Potential benefits of the CTBT and thoughts on cooperation

    International Nuclear Information System (INIS)

    Gebeyehu, G.

    1999-01-01

    In the past years Ethiopia became an active participant in the scientific and political development as well as supporter of the CTBT. This paper describes the designated institution for the CTBT implementation in the area of Radionuclides in Ethiopia and its scientific and regulatory program as well as main activities concerning application techniques. The second part of the paper accounts for the links between the objectives of the national institute with the CTBT. It draws substantive details about benefits that could arise from participating in CTBT implementation and summarizes the discussion by suggesting modalities for building partnership and cooperation

  10. The argument for pharmaceutical policy.

    Science.gov (United States)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-02-01

    Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

  11. Pharmaceuticals labelled with stable isotopes

    International Nuclear Information System (INIS)

    Krumbiegel, P.

    1986-11-01

    The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)

  12. Unproven stem cell-based interventions & physicians' professional obligations; a qualitative study with medical regulatory authorities in Canada.

    Science.gov (United States)

    Zarzeczny, Amy; Clark, Marianne

    2014-10-14

    The pursuit of unproven stem cell-based interventions ("stem cell tourism") is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct. We conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians' professional regulatory bodies in Canada. When considering physicians' professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians' obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by

  13. Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2005. Annual report 2005

    International Nuclear Information System (INIS)

    Zemanova, D.; Seliga, M.; Sladek, V.

    2006-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2005 is presented. These activities are reported under the headings: Foreword; (1) Vision, Mission and Principles of Activities; (2) Legislation; (3) Issuance of Authorisations, Safety Assessment and Enforcement; (4) Nuclear Safety of Nuclear Installations in the Slovak Republic; (4.1) Nuclear installations in operation in the Slovak Republic; (4.2) Nuclear Installations under construction in the Slovak Republic; (4.3) Decommissioning of nuclear installations in the Slovak Republic; (5) Spent Fuel and Radioactive Waste Management and Safety of other Nuclear Installations in the Slovak Republic; (5.1) Generation and minimisation of radioactive waste; (5.2) Management of radioactive waste; (5.3) Pre-disposal management of radioactive waste; (5.4) Disposal of radioactive waste; (5.5) Shipment of radioactive waste; (5.6) Safety of other nuclear installations in the Slovak Republic; (6) Personnel Qualification and Training; (7) Nuclear Materials and Physical Protection of Nuclear installations; (8) Emergency Preparedness; (9) International Co-operation; (10) Public Communication; (11) UJD SR; (11.1) UJD SR organizational chart; (11.2) UJD SR organizational chart; (11.3) Human resources and training; (11.4) Internal system of quality assurance; (11.5) Development of UJD SR regulatory activities; Appendix: Abbreviations; Development of UJD SR regulatory activities

  14. Author Details

    African Journals Online (AJOL)

    Laiyemo, OO. Vol 5, No 1 (2008) - Articles The effects of advertising on sales in the pharmaceutical industry in Nigeria - A survey. Abstract. ISSN: 1596-8499. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions ...

  15. Author Details

    African Journals Online (AJOL)

    Okunlola, A. Vol 12, No 3 (2009) - Articles Generic versus innovator: Analysis of the pharmaceutical qualities of paracetamol and ibuprofen. Abstract PDF. ISSN: 1026-552X. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms ...

  16. Pharmaceutical product development: A quality by design approach

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  17. Pharmaceutical product development: A quality by design approach.

    Science.gov (United States)

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

  18. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  19. Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness?

    Science.gov (United States)

    Snodin, D J

    2015-12-01

    A critical evaluation of several recent regulatory risk assessments has been undertaken. These relate to propyl paraben (as a food additive, cosmetic ingredient or pharmaceutical excipient), cobalt (in terms of a safety-based limit for pharmaceuticals) and the cancer Threshold of Toxicological Concern as applied to food contaminants and pharmaceutical impurities. In all cases, a number of concerns can be raised regarding the reliability of the current assessments, some examples being absence of data audits, use of single-dose and/or non-good laboratory practice studies to determine safety metrics, use of a biased data set and questionable methodology and lack of consistency with precedents and regulatory guidance. Drawing on these findings, a set of recommendations is provided to reduce uncertainty and improve the quality and robustness of future regulatory risk assessments. © The Author(s) 2015.

  20. Safety of nuclear installations in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic in 2007

    International Nuclear Information System (INIS)

    Zemanova, D.

    2008-01-01

    Prepared pursuant to the provisions of the Atomic Act, the report provides information on the safety of nuclear installation in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic ( UJD SR). UJD SR executes its activities in the area of legislation, issuance of authorizations and permissions for the siting, construction, operation and decommissioning of nuclear installations, in the area of reviews, assessments and control of nuclear safety of nuclear installations and emergency planning, in the area of records and accountability of nuclear materials, independent public information and in the area of international co-operation focused on peaceful uses of nuclear power. Based on the results of inspection activities and evaluation of safety indicators, UJD SR assessed the operation of nuclear installations in the Slovak Republic as safe and reliable. No significant event that could have a negative impact on the personnel, population or environment occurred in 2007. (orig.)

  1. New PAT tools for assessing content uniformity, sampling error, and degree of crystallinity in pharmaceutical tablets

    DEFF Research Database (Denmark)

    Warnecke, Solveig

    of the pharmaceutical drug, both during development and throughout the production. The usage of PAT tools is encouraged by the regulatory authorities, and therefore the interest in new and improved PAT tools is increasing. The main purpose of introducing Quality by Design (QbD) and PAT in pharmaceutical production...... practice in traditional pharmaceutical industry. In this thesis, three spectroscopic PAT tools are investigated, near-infrared-, terahertz-, and fluorescence-spectroscopy. These techniques have been evaluated with chemometrics and theory of sampling. The first study focused on the critical but rather...... overlooked sampling uncertainty that exist in all analytical measurements. The sampling error was studied using an example involving near infrared transmission (NIT) spectroscopy to study content of uniformity of five batches of escitalopram tablets, produced at different active pharmaceutical ingredients...

  2. Nanocrystals Technology for Pharmaceutical Science.

    Science.gov (United States)

    Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng

    2018-05-17

    Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  3. Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.

    Science.gov (United States)

    Kinter, Lewis B; DeGeorge, Joseph J

    2016-12-01

    Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations. While each transformation resulted in more effective and/or safer pharmaceuticals, overall attrition, cycle time, cost, numbers of animals used, and low probability of success for new products remain concerns, and pharmaceutical development remains a very high risk business proposition. In this manuscript we review pharmaceutical development since ancient times, describe its coevolution with animal experimentation, and attempt to predict the characteristics of future transformations. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  4. Building competence in radiation and nuclear safety through education and training - the approach of a national regulatory authority

    International Nuclear Information System (INIS)

    Karfopoulos, K.L.; Carinou, E.; Kamenopoulou, V.; Dimitriou, P.; Housiadas, Ch.

    2015-01-01

    The Greek Atomic Energy Commission (EEAE) is the national competent authority for radiation and nuclear safety and security as well as for the radiation protection of ionizing and artificially produced non-ionizing radiation. The legal framework determines, inter alia, the responsibilities in education and training issues. The EEAE has a range of activities, in providing postgraduate and continuous education and training on radiation protection, and nuclear safety and security, at the national and international levels. At the national level, and particularly in the medical field, the EEAE is a participant in and a major contributor to the Inter-University Postgraduate Program on Medical Radiation Physics. Since 2003, the EEAE has been the Regional Training Center (RTC) for radiation, transport and waste safety of the International Atomic Energy Agency (IAEA) for the European Region in the English language. Moreover, the EEAE has also been recognized as the IAEA's Regional Training Center (RTC) in nuclear security in the English language since 2013. The EEAE recently proceeded to two significant initiatives: the design of a national program for education and training, and the certification of the Department of Education according to ISO 29990:2010. In this paper, the initiatives taken to enhance the radiation protection system in the country through education and training are presented. (authors)

  5. Improvements related with the safety required by the Argentine Regulatory Authority to the Atucha I Nuclear Central

    International Nuclear Information System (INIS)

    Calvo, J.; Michelin, C.; Navarro, R.; Waldman, R.

    2006-01-01

    The Argentinean Nuclear Regulation Authority (ARN) verified the existence of changes in the state of some internal components of the reactor of the Atucha I Nuclear Power station that, of continuing in the time, it could take to an inconvenient degradation for the safety operation of the installation. In consequence, to the effects of preventing that reach this situation, at the end of 1999, the ARN required to the Responsible Entity for the operation of this power station the implementation of an important improvements program in the internal components of the reactor. Additionally, and based on the results of the Probabilistic Safety analysis, it was added the one mentioned improvements program the implementation of an alternative cooling system of the reactor core denominated Second Drain of Heat, due to it was determined that, for some accidental sequences, their performance would reduce considerably the probability of damage to the core. The concretion of the improvements program implied to the Responsible Entity the realization of an important quantity of engineering studies, tests and specific inspections that allowed to carry out changes on the control bars of the reactor and its guide tubes; the coolant channels; the sensors of neutron flow; and diverse components of the primary and moderator systems. On the other hand also it was implemented the system Second Drain of Heat, what represents a considerable effort to make compatible the instrumentation and control of last generation, with the instrumentation and existent control systems in the power station. Also, it was requested to be carried out an integrity of the pressure recipient for to demonstrate the existence of an acceptable margin for the difference among the acceptable limit temperatures and of ductile/fragile transition of the material for all the possible accidental scenarios during the useful life of the reactor. (Author)

  6. ASSUMING REGULATORY AUTHORITY FOR TRANSNATIONAL TORTS: AN INTERSTATE AFFAIR? A HISTORICAL PERSPECTIVE ON THE CANADIAN PRIVATE INTERNATIONAL LAW TORT RULES

    Directory of Open Access Journals (Sweden)

    Roxana Banu

    2013-02-01

    Full Text Available In Tolofson v. Jensen, the Supreme Court of Canada determined that in most cases the law of the place where the tort occurred has exclusive authority to regulate all legal aspects related to it. In developing this choice of law rule, the Supreme Court relied on an analogy between Private International Law and Public International law. This allows Private International Law to claim a structural, neutral function in the distribution of legislative authority in the international realm and to ignore both private law and public law considerations. To best reveal the way in which the Supreme Court injected these limitations into Private International Law by reference to Public International Law, I show the striking similarity between the Supreme Court’s reasoning and several Private International Law writings at the end of the 19th century in Continental Europe. In the context of the extraterritorial tortious activity of multinational corporations, these limitations make Private International Law oblivious to arguments of Corporate Social Responsibility scholars showing that a multinational corporation may legitimately be regulated by the state of its headquarters, even for extraterritorial conduct. Overall, I argue that an overemphasis on legislative authority as a symbol of state sovereignty transforms Private International Law matters generally, and transnational torts in particular, in inter-state affairs, removed from the interests and pleas of the individuals and communities affected by them.   Dans l’arrêt Tolofson c. Jensen, la Cour suprême du Canada a décidé que, dans la plupart des cas, la loi du lieu où le délit a été commis régit exclusivement tous les aspects juridiques qui s’y rapportent. Pour établir cette règle du choix de la loi applicable, la Cour suprême s’est fondée sur une analogie entre le droit international privé et le droit international public. Cela permet au droit international privé de réclamer une

  7. Federal, state, and local regulation of radioactive-waste transportation: Progress toward a definition of regulatory authority

    International Nuclear Information System (INIS)

    Livingston-Behan, E.A.

    1986-01-01

    The supremacy clause, the commerce clause, and the equal-protection guarantees of the U.S. Constitution establish the basic framework for defining the authority of Federal, State, and local governments to regulate the transportation of radioactive waste. Court decisions and advisory rulings of the U.S. Department of Transportation (DOT) suggest that State and local regulation of the transportation of spent nuclear fuel and high-level radioactive waste is precluded under supremacy-clause principles to the extent that such regulation addresses nuclear safety or aspects of transportation that are already specifically regulated by the Federal government. Even where State and local requirements are found to be valid under the supremacy clause, they must still satisfy constitutional requirements under the commerce and equal-protection clauses. Despite stringent standards of review, State and local transportation requirements have been upheld where directly related to the traditional exercise of police powers in the area of transportation. Legitimate State and local police-power activities identified to date by the DOT and the courts include inspection and enforcement, immediate accident reporting, local regulation of traffic, and certain time-of-day curfews. The extent to which State and local permitting requirements and license fees may be determined valid by the DOT and the courts remains unclear. Continued clarification by the DOT and the courts as to the validity of permits and fees will serve to further define the appropriate balance for Federal, State, and local regulation of radioactive-waste transportation

  8. Slovak Republic decree of 6 September 1999 of the Nuclear Regulatory authority of the Slovak Republic about breakdown planning for the case of an accident or breakdown

    International Nuclear Information System (INIS)

    1999-01-01

    The Nuclear Regulatory authority of the Slovak Republic constitute: (A) of content, appurtenances and procedure of elaborate (1) of nuclear accident plans (emergency plans), (2) of plan of protection of inhabitants, (3) of accident transport order; (B) measures and procedures which constitute a assumptions for prevention, defeat and mitigation of consequences of breakdowns and accidents, (C) of procedure of apprise of the public, (D) of definition of emergency area in surroundings of nuclear equipment, (E) of periodicity of practice of the emergency planes. This decree contains three appendixes: (1) The minimal extent of data for regular apprise of the public; (2) The international nuclear event scale for means of apprise of the public; (3) The minimal extent of data for apprise of the public for the case of event (breakdown or accident) on nuclear equipment; (4) The intervention levels for urgent and consequent measures for inhabitant protection. This decree shall into effect on 1 October 1999

  9. Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2006. Annual Report 2006

    International Nuclear Information System (INIS)

    Zemanova, D.; Pirozekova, M.

    2007-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2006 is presented. These activities are reported under the headings: Foreword; (1) Vision, Mission and Principles of Activities; (2) Legislation; (3) Issuance of Authorisations, Safety Assessment and Enforcement; (3.1) Issuance of Authorizations/Permissions; (3.2) Assessment and Inspections Activities; (3.3) Safety Assessment and Enforcement; (4) Nuclear Safety of Nuclear Installations in the Slovak Republic; (4.1) Nuclear installations in operation in the Slovak Republic; (4.2) Nuclear Installations under construction in the Slovak Republic; (4.3) Decommissioning of nuclear installations in the Slovak Republic; (5) Safety of Other Nuclear Installations; (5.1) Other Nuclear Installations in Operation; (5.2) Other Nuclear Installations under Construction; (5.3) Other Nuclear Installations under Decommissioning; (6) Management of Radioactive Waste; (6.1) Generation and minimisation of radioactive waste; (6.2) Management of radioactive waste; (6.3) Pre-disposal management of radioactive waste; (6.4) Disposal of radioactive waste; (6.5) Shipment of radioactive waste; (7) Nuclear Materials; (7.1) Accounting for and Control of Nuclear Materials; (7.2) Shipment of Nuclear Materials; (7.3) Illicit Trafficking of Nuclear Materials and Other Radioactive Material; (8) Emergency Planning and Preparedness; (9) International Activities; (9.1) European Affairs; (9.2) Membership in International Organisations; (9.3) Fulfilment of Obligations under International Contractual Instruments; (9.4) Bilateral Co-operation; (10) Public Communication; (11) UJD SR; (11.1) Economy Data; (11.2) Human resources and training; (11.3) Internal Management Quality System; (11.4) Development of UJD SR Regulatory Activities; (12) Abbreviations

  10. Pharmaceutical Cocrystals

    OpenAIRE

    Korotkova, Elena I.; Kratochvíl, B.

    2014-01-01

    Cocrystals are very interesting and useful product. In this paper the main information about cocrystals is presented. It is shown that cocrystals are solid substances, which consist of few components mixed together. There are a lot of ways of cocrystals production and application. It is shown that cocrystals can be applied in medicine and pharmaceutical industry for improving different properties such as dissolution rate, melting point, solubility, chemical stability etc. Another way of cocry...

  11. Pharmaceutical virtue.

    Science.gov (United States)

    Martin, Emily

    2006-06-01

    In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

  12. Implementation of new policy and principles of harmonisation of nuclear emergency preparedness in conditions of emergency Response Centre of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Janko, K.; Zatlkajova, H.; Sladek, V.

    2003-01-01

    With respect to Chernobyl accident the changes in understanding of nuclear emergency preparedness have initiated a developing process resulting in an effective enhancement of conditions ensuring adequate response to nuclear or radiological accidents of emergency situations in many countries. The Slovak Nuclear Regulatory Authority (UJD) in frame of co-operations with IAEA, EC, OECD/NEA and other international organisations has actively participated in this challenging work targeting implementation of international experience and best practices in the country. The new international policy (principles declared e.g. in 'Memorandum of Understanding', IAEA, Vienna, 1997) based on experiences propagating importance of regional co-operation, harmonised approach and clear strategy for protective measures implementation in case of a nuclear or radiological accident has influenced the development also in Slovakia. The implementation process in the country was supported by changes in legal conditions regulating peaceful use of nuclear energy [1,2] including basic rules for emergency preparedness published in the second half of 1990 years. The principles of emergency preparedness in Slovakia fully support regional harmonisation and co-operation. Effective implementation of international practice and sharing of experience substantially contributed to the level of emergency response in the country and to the harmonisation of emergency response preparedness creating also conditions for an efficient regional integration. (authors)

  13. The Strategic Involvement of Women in Nigeria Nuclear Industry: A Case of Nigeria Atomic Energy Commission (NAEC) and Nigerian Nuclear Regulatory Authority (NNRA)

    International Nuclear Information System (INIS)

    Aina, F.; Ala, A.

    2015-01-01

    The involvement of women in the nuclear industry can not be over emphasised as the western world has gone beyond the barrier of gender imbalance. This barrier, I think should be abolished in developing countries so as to help encourage more women to contribute and help build a strong nuclear industry. In Nigeria, the Nigeria Atomic Energy Commission executes a deliberate strategy to address gender imbalance in its activities. Although the nuclear industry is just beginning to evolve, the major organizations namely Nigeria Atomic Energy Commission (NAEC) and Nigerian Nuclear Regulatory Authority (NNRA) have encouraged females to take key positions in the organizations. NAEC has performed better than the national average in achieving gender balance. In a country that has a goal of having women in 35% of her elective and appointed offices, the legal department of NAEC is 100% female. Women have been educated and trained in technical areas such as nuclear engineering, nuclear law, nuclear security, radiation protection and non-proliferation. This paper reviews the strategic approach of these Commissions in engaging women, the profile of some of the leading women and the contribution of the female dominated departments to male dominated departments. (author)

  14. The path from biomarker discovery to regulatory qualification

    CERN Document Server

    Goodsaid, Federico

    2013-01-01

    The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site:  http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different...

  15. Robust Market Launch Planning for a Multi- Echelon Pharmaceutical Supply Chain

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus; Grunow, Martin; Gani, Rafiqul

    2011-01-01

    launching activities after the drug has been approved. In this paper, we present a recourse-based stochastic model, which allows for time phasing the market entries to balance the fluctuating demand with the fixed and periodic production of the active pharmaceutical ingredient. The two major risk elements...... during launch are forecasting inaccuracy and the risk of a required label change from local regulatory authorities. Robust solutions are found by implementing the Robust Optimization framework....

  16. Emergency control center of the nuclear Regulatory Authority: a national, regional and international tool to coordinate the response to radiological and nuclear emergencies

    International Nuclear Information System (INIS)

    Jordan, Osvaldo; Hernandez, Daniel; Telleria, Diego; Bruno, Hector; Boutet, Luis; Kunst, Juan; Sadaniowski, Ivana; Rey, Hugo

    2008-01-01

    Full text: In the year 1998, with the regulation of the Nuclear Law, the Nuclear Regulatory Authority (ARN) is constituted as the national coordinator of the response in case of nuclear or radiological emergencies. The ARN builds his first operative center installed in his Head quarter in Buenos Aires. Likewise, from the obligations that come with the Convention of Early Notification of a Nuclear Accident and Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency, the ARN is the National Warning Point and the National Competent Authority. Therefore, the operative capacity of the center needs to be expanded to cover not only the national territory but also its link with the region and the IAEA, as an access point to the International community, as the conventions demand. For the purpose of giving ARN capacities which reflect the state of art at the international level on Nuclear Emergency Centers and warrant that its equipment and technology will be compatible with those abroad (mainly with IAEA), the ARN made an arrangements with Department of Energy of United States, in the framework of an existing bilateral Argentine Foreign Office/US Government agreement (Joint Standing Committee on Nuclear Cooperation). This agreement allows a deep experience exchange, high level specialists support and last generation equipment access. As a result, the center of ARN can be considerate as the most advanced civil nuclear emergency center in the region. This work describes the implementation process of the emergency center and the technical features, like the physical distribution, hardware and software resources, communication equipment, Geographic Information Systems, etc. (author)

  17. Recent trends in the impurity profile of pharmaceuticals

    Directory of Open Access Journals (Sweden)

    Kavita Pilaniya

    2010-01-01

    Full Text Available Various regulatory authorities such as the International Conference on Harmonization (ICH, the United States Food and Drug administration (FDA, and the Canadian Drug and Health Agency (CDHA are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (APIs. The various sources of impurity in pharmaceutical products are - reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \\ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation, enantiomeric impurity, and so on. The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas-liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid-liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC-Mass Spectroscopy (MS, LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

  18. Actions of the Cuban Nuclear Regulatory Authority in the adequate implementation of the legislation in matter of radiological protection; Acciones de la Autoridad Reguladora Nuclear cubana en la adecuada implementacion de la Legislacion en materia de proteccion radiologica

    Energy Technology Data Exchange (ETDEWEB)

    Fornet R, O.M. [Delegacion Territorial CITMA. Peralta No.16, Rpto Peralta, Holguin, CP 80400 (Cuba); Guillen C, A.; Betancourt H, L.A. [Centro Nacional de Seguridad Nuclear, Calle 28 No.504, Miramar Playa, La Habana (Cuba)]. e-mail: ofelia@citmahlg.holguin.inf.cu

    2006-07-01

    The effectiveness of the regulatory activity in matter of safety and radiological protection it depends in great measure of the practical implementation level of the legislation in this matter. In our country this objective has been achieved through the one continuous improvement of the Hierarchical System of Nuclear Regulation, the reconciliation with specialists and national experts in each matter during the elaboration of the legal documents; the popularization and gratuitous distribution of it approved; the precision in the validation conditions of the authorizations of those main precepts applicable to the practices; the legal foundation of the deficiencies evidenced in the regulatory inspections; the development of a Safety Culture; the realization of Annual Regulatory Conferences and mainly in the training of the personnel related with the safety. Also, the constant analysis on the part of the specialists of the Regulatory Authority of the grade of implementation of this legislation, it discussion in national and international events and the actions recommended in these works. As a result of this focus, it is considered that the Regulatory Authority has impacted appropriately in the implementation of this legislation. (Author)

  19. SOME ASPECTS OF UNIFORMIZATION OF THE LAW AND THE PROBLEMS OF ELECTRICITY AND THE NATIONAL REGULATORY AUTHORITY FOR ENERGY IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Ovidiu Joița

    2014-11-01

    Full Text Available Overview. The concept of internal market it is a crucial and central ones in European modern construction. After the third legal package in energy the internal market of energy (electricity and gas have to be fulfill until the end of 2014.Is this functional or just a theoretical projection? Can we see a direct and quantifiable effects? Is the regulation of energy network industries a proper answer and a direct intervention of State or have to be balance by competition? Is competition possible without regulation on this issue? Regulation of network industries is the prerequisite condition but without a real competition will be not an internal market. Methods. We assessed an individual case and possible scenario for Romania. Also a comparative methods was in place for understanding and analyses institutions (national regulatory authority and mechanism of the market with some focus on the financial markets. Results. The methods used revealed that institution, with unambiguously attribution and competence, autonomous and independent and working mechanism with unambiguously attribution and competence represent a tools for achieve a real market. Nevertheless the predictable and well done regulations in energy, with a large debate with all the actors involved it is indispensable tools.

  20. Activities of the Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear facilities in the Slovak Republic in 1994

    International Nuclear Information System (INIS)

    1995-01-01

    The report summarizes activities of the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1994 and briefly presents results of the national expert supervision over nuclear safety facilities in the SR in 1994. In 1994, the NRA SR have performed a national supervision of following organizations: SE, a.s. - Jaslovske Bohunice Nuclear Power Plant (V-1 Nuclear Power Plant (V-1 NPP), V-2 Nuclear Power Plant (V-2 NPP), A-1 Nuclear Power Plant (A-1 NPP)); Mochovce Nuclear Power Plant; Radioactive waste repository, Mochovce); Organizations providing a specialized training of NPP personnel; Organizations providing specific deliveries and activities for the nuclear power industry; Organizations having an owner of nuclear materials; Organizations providing activities related to import of radioactive sources; Organizations using radioactive sources. Organization structure of the NRA SR is explained. In the presented Chapter 1 - Safety of nuclear power plants in the Slovak Republic - safety aspects of the Slovak NPPs are reported. The next activities are reported: nuclear materials and safeguards; radioactive waste; emergency planning and NRA SR's control and crisis centre; international activities to improve the national surveillance quality; other activities

  1. IAEA meeting: International conference of national regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials

    Energy Technology Data Exchange (ETDEWEB)

    Englefield, Chris [UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group, Environment Agency (United Kingdom)

    2001-06-01

    deterministic risks, and to a lesser extent stochastic risks. There are other issues which should also be factored in. (ii) The accidents that attract media and other international/political attention are those with high exposures (especially if they are fatal). Many people involved in the conference would recognise other social and economic risks, in the event of sources being melted in a metals works. (iii) States which have only recently created regulatory systems, or that have very low numbers of users, tend to have a single regulatory authority to cover all uses of 'nuclear' material (e.g. Costa Rica). (iv) States which have a long history of use tend to have multiple-bodies involved in the regulation of radiation sources (e.g. the UK where there are nine or Germany where there are seventeen). (v) States with few users often manage an effective national inventory system . (vi) States with many users rarely run a national inventory system. (viii) Many states operate a national waste management/disposal system that takes control of orphaned or disused sources, when necessary, as a national service; some states have a more commercial approach. Sometimes even the latter type are prepared to 'adopt' orphaned sources and the liabilities that come with them. The recurring themes that emerged were: (i) The need for education and training of all stakeholders (users, regulators, the public, medics, judges, politicians). (ii) The need for an international communication system between regulators The paper I submitted described the UK regulatory arrangements in its first part, as operated by the environment agencies and HSE. It then went on to describe the constitution and work of the UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group. The UK paper also briefly: (i) summarised the nature and consequences of the March 2000 AVESTA accident; (ii) proposed that an 'all risks' approach be considered, as this is proving useful to the UK. The

  2. 'Linkage' pharmaceutical evergreening in Canada and Australia

    OpenAIRE

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong...

  3. [Operation Pangea - standing together in combat against international pharmaceutical crime].

    Science.gov (United States)

    Smolka, Kirstin; Gronwald, Klaus

    2017-11-01

    Crime on the internet has grown accordingly to the increased use of the internet in everyday life. This includes illegal trading of pharmaceuticals via the internet. Trading in pharmaceuticals as "special commodities" underlies certain legal regulations in Germany, as in most other countries worldwide.Mail order trade (colloquially also known as internet trade) in pharmaceuticals requires approval of the competent regulatory authority. However, numerous illegal internet vendors of medicines present their websites to customers, purporting to be legal pharmacies and trading good and genuine medicines.It is not always easy for customers or patients to distinguish between legal websites, i. e. pharmacies operating with the approval of the authorities, and illegal, criminal websites. Patients accept dangerous risks when they order medicines on such illegal websites. Consumption of falsified or unlicensed pharmaceuticals of unknown origin often exposes patients' health to serious risks and dangers.Operation PANGEA is now in its tenth year of fighting illegal internet trade in pharmaceuticals at an internationally coordinated level. The results of Operation PANGEA are published in national and international media. Thus the public should be alert to the risks of buying medicines from one of the numerous illegal vendors on the internet.The competence for combatting illegal sales of medicines lies with customs and police agencies amongst others. These enforcement agencies regularly participate in the annual PANGEA Operations. The following article describes the origin and background of this operation, and outlines both the work of customs and police in this context, as well as the results of the latest PANGEA Operation.

  4. The argument for pharmaceutical policy

    DEFF Research Database (Denmark)

    Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

    2005-01-01

    and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how...

  5. [PICS: pharmaceutical inspection cooperation scheme].

    Science.gov (United States)

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  6. Integrating systems Approaches into Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.

    2008-01-01

    During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the ‘Integration of Systems Approaches into Pharmaceutical Sciences’ in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive drug solutions...... for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European Regulatory Agencies and FDA...

  7. Pharmaceutical powder compaction technology

    National Research Council Canada - National Science Library

    Çelik, Metin

    2011-01-01

    "Revised to reflect modern pharmaceutical compacting techniques, this Second Edition guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel...

  8. A cheat sheet to navigate the complex maze of pharmaceutical exclusivities in Europe.

    Science.gov (United States)

    Tomas, Marta Cavero; Peng, Bo

    2017-07-01

    As the two leading markets for pharmaceutical and biotech companies, the USA and Europe offer incentives to stimulate drug innovation, including patent and regulatory exclusivities. These exclusivities extend periods during which companies can market their products free of generic or other competition and recoup their investment. Pharmaceutical and biotech companies should carefully assess the different types of exclusivities available when developing regulatory submissions, patent filing strategies. The authors have previously summarized the USA exclusivities in an earlier publication. This article focuses on European exclusivities. Due to space limitations, it focuses on small molecule drugs. Analogously to the format previously used, we have provided a cheat sheet of European exclusivities for small molecule drugs in Figure 1 .

  9. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation.

    Science.gov (United States)

    Pallagi, Edina; Ambrus, Rita; Szabó-Révész, Piroska; Csóka, Ildikó

    2015-08-01

    Regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities nowadays. The aim of this study was to adapt regulatory science even in the nano-pharmaceutical early development. Authors applied the quality by design (QbD) concept in the early development phase of nano-systems, where the illustration material was meloxicam. The meloxicam nanoparticles produced by co-grinding method for nasal administration were studied according to the QbD policy and the QbD based risk assessment (RA) was performed. The steps were implemented according to the relevant regulatory guidelines (quality target product profile (QTPP) determination, selection of critical quality attributes (CQAs) and critical process parameters (CPPs)) and a special software (Lean QbD Software(®)) was used for the RA, which represents a novelty in this field. The RA was able to predict and identify theoretically the factors (e.g. sample composition, production method parameters, etc.) which have the highest impact on the desired meloxicam-product quality. The results of the practical research justified the theoretical prediction. This method can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation. It makes possible focusing the resources on the selected parameters and area during the practical product development. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. The pharmaceutical quality revolution

    Directory of Open Access Journals (Sweden)

    Jordi Botet

    2016-01-01

    Full Text Available Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality

  11. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.

    Science.gov (United States)

    2016-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

  12. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

    Directory of Open Access Journals (Sweden)

    Andreas Vilhelmsson

    2016-01-01

    Full Text Available European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1 characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2 shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA, between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%, using print material (70/72, 97%, for example, advertisements (21/70, 30%. Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%. Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%, payers (n = 2, 3%, or company staff (n = 2, 3%. Eight UK rulings (11% pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US

  13. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

    Science.gov (United States)

    Vilhelmsson, Andreas; Davis, Courtney; Mulinari, Shai

    2016-01-01

    European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However

  14. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012

    Science.gov (United States)

    Vilhelmsson, Andreas; Davis, Courtney; Mulinari, Shai

    2016-01-01

    Background European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. Methods and Findings We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by

  15. FORMATION AND FURTHER DEVELOPMENT OF MODERN PROMOTION OF PHARMACEUTICAL PRODUCTS

    Directory of Open Access Journals (Sweden)

    Юрий Владимирович Тарасов

    2014-02-01

    Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2

  16. Pharmaceutical Regulatory Framework in Ethiopia: A Critical ...

    African Journals Online (AJOL)

    This legislation formed the legal basis for official establishment of drug regulation in the history of Ethiopia, enabling the regulation of the practice of pharmacists, druggists and pharmacy technicians; manufacturing, distribution, and sale of medicines. In June 1999, a new regulation called the “Drug Administration and ...

  17. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  18. Basic pharmaceutical technology

    OpenAIRE

    Angelovska, Bistra; Drakalska, Elena

    2017-01-01

    The lecture deals with basics of pharmaceutical technology as applied discipline of pharmaceutical science, whose main subject of study is formulation and manufacture of drugs. In a broad sense, pharmaceutical technology is science of formulation, preparation, stabilization and determination of the quality of medicines prepared in the pharmacy or in pharmaceutical industry

  19. Container-content compatibility studies: a pharmaceutical team's integrated approach.

    Science.gov (United States)

    Laschi, Alda; Sehnal, Natacha; Alarcon, Antoine; Barcelo, Beatrice; Caire-Maurisier, François; Delaire, Myriam; Feuilloley, Marc; Genot, Stéphanie; Lacaze, Catherine; Pisarik, Luc; Smati, Christophe

    2009-01-01

    Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation

  20. Design of Continuous Crystallizers for Production of Active Pharmaceutical Ingredients

    DEFF Research Database (Denmark)

    Capellades Mendez, Gerard; Christensen, Troels V.

    The production of Active Pharmaceutical Ingredients (APIs) is conducted primarily in batch processes. This manufacturing approach is reinforced by a patent-driven business model and the need to minimize the process development times for newly patented drugs. However, the regulatory and business...... environments are now changing. The increasing costs of drug development, combined with the strict regulations and the competition from generic manufacturers, have pushed pharmaceutical companies to seek cheaper and more sustainable production methods. Transition from batch to Continuous Pharmaceutical...

  1. 'Linkage' pharmaceutical evergreening in Canada and Australia

    Science.gov (United States)

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  2. H.R. 3532: This act may be cited as the Nuclear Regulatory Commission Authorization Act for Fiscal Year 1999. Introduced in the House of Representatives, One Hundred Fifth Congress, Second Session, March 24, 1998

    International Nuclear Information System (INIS)

    1998-01-01

    This bill authorizes appropriations for the Nuclear Regulatory Commission for fiscal year 1999. It is divided into the following sections: Section 1. Short title; Section 102. Allocation of amounts authorized; Section 103. Retention of funds; Section 104. Transfer of certain funds; Section 105. Limitation; Section 106. License fee exemption; Section 107. NRC user fees and actual charges. Section 201. Office location; Section 202. Period of a combined license; Section 203. Gift acceptance authority; Section 204. Carrying of firearms by licensee employees; Section 205. Sabotage of production, utilization or waste storage facilities under construction; Section 206. Unauthorized introduction of dangerous weapons; and Section 207. Continuation of Commissioner service

  3. Draft Law on the creation, attribution, organization and functioning of a ''Regulatory Authority and Nuclear Safety'' (ARSN)

    International Nuclear Information System (INIS)

    Issoufou, Mahamadou

    2016-08-01

    This Draft Law deals with the establishment, responsibilities, organization and functioning of an Autority Control and Nuclear Safety. Through this law, the Regulatory and Nuclear Safety Autority is responsible for regulation of nuclear and radiological activities to ensure the safety, security and protection of persons and the environment against the effects of radiation throughout the national territory. [fr

  4. Assessing the assessments: Pharmaceuticals in the environment

    International Nuclear Information System (INIS)

    Enick, O.V.; Moore, M.M.

    2007-01-01

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development

  5. Pharmaceutical technology management--profitable business avenue.

    Science.gov (United States)

    Puthli, Shivanand P

    2010-01-01

    Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

  6. Funding pharmaceutical innovation through direct tax credits.

    Science.gov (United States)

    Lybecker, Kristina M; Freeman, Robert A

    2007-07-01

    Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

  7. Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

    Science.gov (United States)

    Paumgartten, Francisco José Roma

    2016-12-22

    In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

  8. Relevance of variation in use of terminology to define generic pharmaceutical products

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2015-02-01

    Full Text Available The World Health Organization (WHO promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  9. Relevance of variation in use of terminology to define generic pharmaceutical products.

    Science.gov (United States)

    Fonseca, Elize Massard da

    2015-02-01

    The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  10. Studying and evaluating pharmaceutical policy--becoming a part of the policy and consultative process

    DEFF Research Database (Denmark)

    Almarsdóttir, Anna Birna; Traulsen, Janine Marie

    2006-01-01

    In this last article in the series the authors focus on the issue of researching and evaluating pharmaceutical policy. The past five articles made an argument for why pharmaceutical policy is important and why it is different from health policy. The evidence base needed for pharmaceutical policym...... culture around pharmaceutical policy. They emphasize the importance of pharmaceutical specialists' (i.e., pharmacists') involvement in pharmaceutical policy analysis and the policy consultative process....

  11. Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

    Science.gov (United States)

    Cohen-Kohler, Jillian Clare; Esmail, Laura C

    2007-09-01

    This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

  12. PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

    Science.gov (United States)

    Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta

  13. Pharmaceutical care in Kuwait: hospital pharmacists' perspectives.

    Science.gov (United States)

    Katoue, Maram G; Awad, Abdelmoneim I; Schwinghammer, Terry L; Kombian, Samuel B

    2014-12-01

    Pharmaceutical care practice has been championed as the primary mission of the pharmacy profession, but its implementation has been suboptimal in many developing countries including Kuwait. Pharmacists must have sufficient knowledge, skills, and positive attitudes to practise pharmaceutical care, and barriers in the pharmacy practice model must be overcome before pharmaceutical care can be broadly implemented in a given healthcare system. To investigate hospital pharmacists' attitudes towards pharmaceutical care, perceptions of their preparedness to provide pharmaceutical care, and the barriers to its implementation in Kuwait. Six general hospitals, eight specialized hospitals and seven specialized health centers in Kuwait. A descriptive, cross-sectional survey was distributed to all pharmacists working in the governmental hospitals in Kuwait (385 pharmacists). Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (standard deviations) were calculated and compared using statistical package for social sciences, version 20. Statistical significance was accepted at a p value of Kuwait. Completed surveys were received from 250 (64.9%) of the 385 pharmacists. Pharmacists expressed overall positive attitudes towards pharmaceutical care. They felt well prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Pharmacists with more practice experience expressed significantly more positive attitudes towards pharmaceutical care (p = 0.001) and they felt better prepared to provide pharmaceutical care competencies (p Kuwait advocate implementation of pharmaceutical care while also appreciating the organizational, technical and professional barriers to its widespread adoption. Collaborative efforts between health authorities and educational institutions, and the integration of innovative approaches in

  14. Mining Contratação License in the New Regulatory Framework of Brazilian Mining: Some Notes on the Institutes of Research Authorization and Mining Concession

    Directory of Open Access Journals (Sweden)

    Adhemar Ronquim Filho

    2013-06-01

    Full Text Available Given the importance of mining nowadays, Government seeks ways to stimulate its growth, focusing on potentializing research and the advancement of mineral processing, the basic items for speeding up this activity in a profitable way. In this sense, the discussions on the crystallization of a new regulatory framework for the Brazilian mining have been deepened and, despite gathering a significant number of proposals, it does not have a closed text, and, currently, it is far from obtaining an approval or a final word (despite the urgency. However, the analysis of the proposals that have been presented reveals that there is an intention to institute new rules for the modernization of Brazilian mining, and this paper has the purpose of suggesting ways to reconcile conflicts permeated by various dissonant interests that surround the Brazilian mining at this time. It should be emphasized that, given the lack of official disclosure of the amendments proposed, the approach will continue limited to what has been released by MME (Ministry of Mines and Energy and by the studies that have already been presented by experts in the field (connected to government and/or private businesses. It is restricted to discuss changes to be implemented with the new regulatory framework, highlighting points to be observed, and, among the topics that require mandatory update, we can emphasize the changes in the procedures of exploration permits and mining.

  15. Allocation of authority in European health policy.

    Science.gov (United States)

    Adolph, Christopher; Greer, Scott L; Massard da Fonseca, Elize

    2012-11-01

    Although many study the effects of different allocations of health policy authority, few ask why countries assign responsibility over different policies as they do. We test two broad theories: fiscal federalism, which predicts rational governments will concentrate information-intensive operations at lower levels, and redistributive and regulatory functions at higher levels; and "politicized federalism", which suggests a combination of systematic and historically idiosyncratic political variables interfere with efficient allocation of authority. Drawing on the WHO Health in Transition country profiles, we present new data on the allocation of responsibility for key health care policy tasks (implementation, provision, finance, regulation, and framework legislation) and policy areas (primary, secondary and tertiary care, public health and pharmaceuticals) in the 27 EU member states and Switzerland. We use a Bayesian multinomial mixed logit model to analyze how different countries arrive at different allocations of authority over each task and area of health policy, and find the allocation of powers broadly follows fiscal federalism. Responsibility for pharmaceuticals, framework legislation, and most finance lodges at the highest levels of government, acute and primary care in the regions, and provision at the local and regional levels. Where allocation does not follow fiscal federalism, it appears to reflect ethnic divisions, the population of states and regions, the presence of mountainous terrain, and the timing of region creation. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Advancing pharmaceuticals and patient safety in Saudi Arabia: A 2030 vision initiative

    Directory of Open Access Journals (Sweden)

    Tariq M. Alhawassi

    2018-01-01

    Full Text Available Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA, quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API, excipients, etc., manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices. A recent conference in Riyadh, sponsored by King Saud University, sought to discuss these issues and develop specific policy recommendations for the Saudi 2030 Vision plan. This and other efforts will require more and more creative educational programs for physicians, pharmacists, hospitals, and patients, and, most importantly evolving regulations on quality standards and oversight by Saudi health authorities.

  17. Pharmaceutical care in smoking cessation.

    Science.gov (United States)

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

  18. Financing pharmaceuticals in transition economies.

    Science.gov (United States)

    Kanavos, P

    1999-06-01

    This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

  19. Radiation sterilization of pharmaceuticals and biomedical products

    International Nuclear Information System (INIS)

    Blackburn, R.; Iddon, B.; Moore, J.S.; Phillips, G.O.; Power, D.M.; Woodward, T.W.

    1975-01-01

    Sterilization of pharmaceuticals by radiation is accompanied by chemical degradation which must be eliminated or minimised if the method is to be successfully applied. In order to devise ways in which the pharmaceutical can be protected it is necessary to know the yield and nature of the decomposition products, the mechanisms by which degradation occurs, and the rate constants for the reactions involved. We have obtained such data for a variety of pharmaceutical compounds, viz. vitamin B12, benzyl penicillin, sulphonamides, indoles, heparin, alginates and phenylmercurics, both in the solid state and in aqueous solution. The scope and limitations of radiation sterilization are discussed in the light of these results. (author)

  20. 77 FR 47078 - 2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2012-08-07

    ... foundations, emerging technologies and innovations in regulatory science, as well as the current quality and... of today's leading pharmaceutical companies present case studies on how they employ global strategies... Contract Manufacturing Organizations Contract Agreements Drug Safety Emerging Active Pharmaceutical...

  1. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2013-04-04

    ... foundations, emerging technologies and innovations in regulatory science, as well as the current quality and... strategies, while industry professionals from some of today's leading pharmaceutical companies present case.... Drug Safety. Emerging Active Pharmaceutical Ingredients (API) Regulations. Investigations. Emerging API...

  2. The cost of entry: An analysis of pharmaceutical registration fees in low-, middle-, and high-income countries.

    Directory of Open Access Journals (Sweden)

    Steven G Morgan

    Full Text Available Advances in pharmaceuticals offer improved health outcomes for a wide range of illnesses, yet medicines are often inaccessible for many patients worldwide. One potential barrier to making medicines available to all is the cost of product registration, the fees for regulatory review and licensing for the sale of medicines beyond the cost of clinical trials, if needed.We performed a cross-sectional analysis of pharmaceutical registration fees in low-, middle-, and high-income countries. We collected data on market authorization fees for new chemical entities and for generic drugs in 95 countries. We calculated measures of registration fee size relative to population, gross domestic product (GDP, and total health spending in each country. Each of the 95 countries had a fee for registering new chemical entities. On average, the ratio of registration fees to GDP was highest in Europe and North America and lowest in South and Central America. Across individual countries, the level of registration fees was positively correlated with GDP and total health spending, with relatively few outliers.We find that, generally speaking, the regulatory fees charged by medicines regulatory authorities are roughly proportional to the market size in their jurisdictions. The data therefore do not support the hypothesis that regulatory fees are a barrier to market entry in most countries.

  3. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.

  4. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  5. Pharmaceutical care in smoking cessation

    Directory of Open Access Journals (Sweden)

    Marín Armero A

    2015-01-01

    Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy

  6. Author Details

    African Journals Online (AJOL)

    Adepoju, GKA. Vol 5, No 1 (2008) - Articles The effects of advertising on sales in the pharmaceutical industry in Nigeria - A survey. Abstract · Vol 6, No 3 (2009) - Articles A critical analysis of the prospects and constraints to commercialization of indigenous pharmaceutical research and developments outputs in developing ...

  7. Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

    Science.gov (United States)

    Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

    2017-11-01

    Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Human population doses: Comparative analysis of CREAM code results with currently computer codes of Nuclear Regulatory Authority; Dosis en la poblacion: comparacion de los resultados del codigo CREAM con resultados de modelos vigentes en la ARN

    Energy Technology Data Exchange (ETDEWEB)

    Alonso Jimenez, Maria Teresa; Curti, Adriana [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)]. E-mail: mtalonso@sede.arn.gov.ar; acurti@sede.arn.gov.ar

    2001-07-01

    The Nuclear Regulatory Authority is performing an analysis with PC CREAM, developed at the NRPB, for updating computer programs and models used for calculating the transfer of radionuclides through the environment. For CREAM dose assessment verification for local scenarios, this paper presents a comparison of population doses assessed with the computer codes used nowadays and with CREAM, for unitary releases of main radionuclides in nuclear power plant discharges. The results of atmospheric dispersion processes and the transfer of radionuclides through the environment for local scenarios are analysed. The programs used are PLUME for atmospheric dispersion, FARMLAND for the transfer of radionuclides into foodstuffs following atmospheric deposition in the terrestrial environment and ASSESSOR for individual and collective dose assessments.This paper presents the general assumptions made for dose assessments. The results show some differences between doses due to differences in models, in the complexity level of the same models, or in parameters. (author)

  9. The emerging role of MD Pharmacology postgraduate in pharmaceutical industry

    OpenAIRE

    Pratishtha Banga Chaudhari

    2016-01-01

    Patient-benefit is a shared goal of the pharmaceutical company and the treating doctor. At the same time, the pharmaceutical company- in order to recur its R and D costs has to balance patient centricity with making profits. Consequently, the commercial benefits from prescription of a product and education about optimal use of product both become the responsibilities of same organization. This often leads to allegations of bias by the regulators. We are in an era where regulatory bodies close...

  10. Pharmaceutical supply chain risks: a systematic review

    Science.gov (United States)

    2013-01-01

    Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

  11. Pharmaceutical supply chain risks: a systematic review.

    Science.gov (United States)

    Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

    2013-12-19

    Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

  12. Regulatory inspection of the egyptian gamma irradiator using a proposed inspection checklist

    International Nuclear Information System (INIS)

    Abdel-Ghani, A.H.

    2000-01-01

    Regulatory inspections are one of the most important elements of a regulatory programme. It shall be performed in all areas of the regulatory responsibility and during all phases of siting, design, construction, commissioning, operation, maintenance and decommissioning of an irradiator facility. The egyptian mega gamma irradiator operating since december 1979 has a Co-60 source of about 400 kilo curies and is used mainly for sterilization of medical supplies and pharmaceuticals and for preservation of some food stuffs. The constructor (Nordion international Inc.) recommended an extensive inspection programme. In accordance with the international and national (2.3) regulations as well as the licensing conditions, the competent authority (NCNSRC) shall perform regulatory inspections both announced and unannounced. In order to facilitate the inspection task and to harmonize the inspection reports a checklist for inspection is proposed which can be used also as an inspection report form

  13. Evidential Authorization*

    Science.gov (United States)

    Blass, Andreas; Gurevich, Yuri; Moskal, Michał; Neeman, Itay

    Consider interaction of principals where each principal has its own policy and different principals may not trust each other. In one scenario the principals could be pharmaceutical companies, hospitals, biomedical labs and health related government institutions. In another scenario principals could be navy fleets of different and not necessarily friendly nations. In spite of the complexity of interaction, one may want to ensure that certain properties remain invariant. For example, in the navy scenario, each fleet should have enough information from other fleets to avoid unfortunate incidents. Furthermore, one wants to use automated provers to prove invariance. A natural approach to this and many other important problems is to provide a high-level logic-based language for the principals to communicate. We do just that. Three years ago two of us presented the first incarnation of Distributed Knowledge Authorization Language (DKAL). Here we present a new and much different incarnation of DKAL that we call Evidential DKAL. Statements communicated in Evidential DKAL are supposed to be accompanied with sufficient justifications. In general, we construe the term “authorization” in the acronym “DKAL” rather liberally; DKAL is essentially a general policy language. There is a wide spectrum of potential applications of KAL. One ambitious goal is to provide a framework for establishing and maintaining invariants.

  14. Pharmaceutical policy and the pharmacy profession

    DEFF Research Database (Denmark)

    Traulsen, Janine Marie; Almarsdóttir, Anna Birna

    2005-01-01

    In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and indu......In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...

  15. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  16. A comparison of magnetic fields inside and outside high-voltage urban 110-kV power substations with the exposure recommendations of the Ukrainian regulatory authorities

    International Nuclear Information System (INIS)

    Okun, Oleksandr; Shevchenko, Sergey; Korpinen, Leena

    2013-01-01

    The aim of this study was to carry out theoretical investigations of power frequency magnetic fields (MFs), produced inside and outside the domain of urban 110-kV power substations and to establish a correspondence between the levels of the fields and the specified population limits as defined by Ukrainian regulations. The fields produced by high-voltage substations were studied based on the application of the numerical finite element methodology. The investigations have shown that magnetic flux density values calculated inside and outside the considered 110-kV power substations do not reach the exposure limits specified by the Ukrainian regulations (1750 μT) and by international guidelines (ICNIRP 2010). Inside the domain of the substation, the maximum value of MFs was found under the 10-kV bus-bars and it equalled 420 μT. (authors)

  17. Prevention of and response to inadvertent exposure of embryo/fetus to ionizing radiation, due to medical exposure of the mother. The Greek regulatory authority initiatives.

    Science.gov (United States)

    Economides, Sotirios; Boziari, Argiro; Vogiatzi, Stavroula; Hourdakis, Konstantinos J; Kamenopoulou, Vassiliki; Dimitriou, Panagiotis

    2014-03-01

    Embryo/fetus (E/F) irradiation as a result of medical exposure of the mother should be avoided, unless there are strong clinical indications. Medical practitioners are assigned the primary task and obligation of ensuring overall patient protection and safety in the prescription of and during the delivery of medical exposure. In cases of unintended exposure of embryo/fetus (E/F), the risk analysis and communication is conducted by or under the supervision of medical physicists at local level. National competent authorities can contribute to the prevention, risk analysis and communication of inadvertent E/F exposure to ionizing radiation by recording, analyzing and disseminating the relevant information. Since 2001, Greek Atomic Energy Commission has established a committee with the mandate to provide advice, to keep records, to analyze and disseminate the experience gained in cases of unintended E/F exposure. During the period 2001-2011, the committee was consulted by 269 pregnant women undergone medical exposures. The conclusions from the relevant data analysis, as well as the experience gained are herein presented and discussed. Copyright © 2013 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  18. Awareness, training, exchange of information and co-operation among regulatory authorities and other law enforcement institutions. Experience and problems in Latvia

    International Nuclear Information System (INIS)

    Linde, I.; Salmins, A.

    1998-01-01

    Latvia is developing infrastructure to ensure adequate system for safety and security of radioactive and nuclear materials, radiation sources and nuclear facilities within its Radiation and Nuclear Safety legal framework. The first phase of implementation was to establish and develop further relevant legal acts, but in the same time there was a need to improve the technical capabilities for the control of goods movement across the border and the need to establish the relevant educational system. The Ministry of Environmental Protection and Regional Development (MEPRD) started to participate in this process from the early beginning when the problem of illicit trafficking was foreseen. After the technical expertise carried out by the Environmental Data Centre the first border guards and customs control points were equipped with portable measurement devices. By assistance of Nordic countries and USA this system is under constant development, but full scope conceptual analysis of entire problem is not yet finished. The need for further development of the training capabilities, as well as information sharing among all relevant institutions and awareness building for decision-makers still remains. (author)

  19. Pharmaceutical cocrystals: an overview.

    Science.gov (United States)

    Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

    2011-10-31

    Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.

  20. Author Details

    African Journals Online (AJOL)

    2011) - Articles Ultraviolet Spectrophotometric Determination of Simvastain in Pharmaceutical Dosage Forms Abstract · Vol 17, No 1 (2015) - Articles Clinical assessment of the efficacy and safety of T-Angelica Herbal Tonic, a herbal beverage

  1. Importance of the awareness, training exchange of information and co-operation between regulatory authorities and customs, police and other law enforcement agencies

    International Nuclear Information System (INIS)

    Shakshooki, S.K.; Al-Ahaimer, R.O.

    1998-01-01

    Fast developments in science and technology are a great accomplishment in this century. These facilities have been utilized by criminals and deviants by identified way. Industrial developed countries have their own means to improve and to modify technology and scientific facilities to cope up with any new existing problems, such as the problem of illegal trading of nuclear materials. Facilities for exchange of information among industrial countries also play an important role to prevent any dangerous phenomena may exist. In contrast most developing countries lack the means of up-to-date follow up quick and continuous scientific and technological developments. However they have qualified personnel to follow up quickly and to prevent drug and narcotics smuggling. Recently we have heard about a dangerous phenomena, the illegal trading of nuclear materials, which derive attention internationally. The developed countries can cope easily with it. However, in developing countries, their lack of up to date facilities can cause a grate damage to their nations. Libyan Arab Jamahiriya is always willing to co-operate internationally to prevent any new dangerous phenomena. We think it is a time for conformation on international official agreement regarding this phenomena. Exchange of information between different countries through an international agency is important for prohibiting the illegal nuclear materials trading. Also to help in creation of a temporally scientific committee to provide different countries of the world the available information in this area and to co-operate specially with police, custom and law enforcement agencies of each nation providing an international legislation for dealing with such phenomena is a priority. Assistance for the arrangement of training through IAEA is of great importance. (author)

  2. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  3. Recombinant biologic products versus nutraceuticals from plants - a regulatory choice?

    Science.gov (United States)

    Drake, Pascal M W; Szeto, Tim H; Paul, Mathew J; Teh, Audrey Y-H; Ma, Julian K-C

    2017-01-01

    Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regulatory path for such new pharmaceuticals has been a deterrent. Consideration has been given to using alternative regulatory paths, including those for nutraceuticals or cosmetic agents. This review will consider these possibilities, and discuss the difficulties in establishing regulatory guidelines for new pharmaceutical manufacturing technologies. © 2016 The British Pharmacological Society.

  4. EU pharmaceutical expenditure forecast

    OpenAIRE

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives: With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ ph...

  5. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  6. Electrochemical treatment of pharmaceutical and industrial wastewater by anodic oxidation

    International Nuclear Information System (INIS)

    Menapace, H. M.; Fellerer, M.; Treschnitzer, M.

    2009-01-01

    In modern medicine pharmaceuticals play a decisive role: because of an increased life expectancy and intensive care medicine an increasing amount of pharmaceuticals is produced. thus these substances are consumed in a mass of tons per year in industrialized countries. Wastewater effluents from sewage treatment plants (STP) are important point sources for residues of pharmaceuticals and complexing agents in the aquatic environment. For this reason a research project, which started in December 2006, was established to eliminate pharmaceutical substances and complexing agents found in wastewater as micropollutants. (Author)

  7. Exclusion and authorization

    International Nuclear Information System (INIS)

    Cooper, J.R.

    2003-01-01

    'Everyone in the world is exposed to radiation from natural and artificial sources. Any realistic system of radiological protection must have a clearly defined scope if it is not to apply to the whole of mankind's activities'. This quote, from ICRP Publication 60 (ICRP, 1991), remains apposite. The main tool for defining scope is the concept of exclusion: situations, sources or exposures that are excluded from the system of radiological protection are, to all intents and purposes, ignored. Sources and exposures that are not excluded are within the scope of the system of protection and by inference within regulatory systems implementing ICRP recommendations. These sources and exposures should be subject to appropriate authorization by the relevant regulatory authority. In order to avoid excessive regulatory procedures, however, provisions should be made for granting an exemption in cases where it is clear that regulatory provisions are unnecessary. Exemption is a regulatory tool intended to facilitate efficient use of regulatory resources. Nevertheless, the regulatory act of granting exemptions is, in itself, a form of authorization and the material or situation so exempted remains within the regulatory system. This distinction between exclusion and exemption is an important one. Historically, the concept of exclusion has been applied to sources or exposures that are essentially unamenable to control because of their widespread nature. The usually quoted examples are cosmic radiation at ground level and 40 K in the body. Clearly, many exposures from natural sources could fall into this category. The challenges are firstly to establish a sound basis for deciding which should be excluded and which should be controlled, and secondly to see if the concept could or should be applied to artificial sources and exposures. These two questions are the subject of this paper. (author)

  8. Electrostatics of Pharmaceutical Aerosols for Pulmonary Delivery.

    Science.gov (United States)

    Lip Kwok, Philip Chi

    2015-01-01

    This paper provides a review on key research findings in the rapidly developing area of pharmaceutical aerosol electrostatics. Solids and liquids can become charged without electric fields, the former by contact or friction and the latter by flowing or spraying. Therefore, charged particles and droplets carrying net charges are produced from pharmaceutical inhalers (e.g. dry powder inhalers, metered dose inhalers, and nebulisers) due to the mechanical processes involved in aerosolisation. The charging depends on many physicochemical factors, such as formulation composition, solid state properties, inhaler material and design, and relative humidity. In silico, in vitro, and limited in vivo studies have shown that electrostatic charges may potentially influence particle deposition in the airways. However, the evidence is not yet conclusive. Furthermore, there are currently no regulatory requirements on the characterisation and control of the electrostatic properties of inhaled formulations. Besides the need for further investigations on the relationship between physicochemical factors and charging characteristics of the aerosols, controlled and detailed in vivo studies are also required to confirm whether charges can affect particle deposition in the airways. Since pharmaceutical aerosol electrostatics is a relatively new research area, much remains to be explored. Thus there is certainly potential for development. New findings in the future may contribute to the advancement of pharmaceutical aerosol formulations and respiratory drug delivery.

  9. Creating a National Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Way, R.

    2010-01-01

    For a number of reasons, countries throughout the world are now considering the development of new nuclear power programs. Whether it is to meet increased power requirements, lack of indigenous resources or environmental concerns, these countries are looking at nuclear power as a solution to their increasing energy needs. Such an undertaking will require a concerted effort by national industrial firms and several branches of government. This paper will look the various phases that encompass the development of a nuclear power program from the perspective of the human resources development. In short it will consider the following issues: Planning a Human Resource Development strategy; Establishing organization, roles and responsibilities; Establishing an Human Resource Development vision, mission, goals and objectives; Collecting and evaluating data for an HRD needs and resource assessment; Conducting a Human Resource Development needs and resource assessment; Determining short-, medium-, and long-term needs; Developing an implementation plan to address education, training, recruitment, retention and knowledge management; Establishing systems that monitor, evaluate and anticipate HRD needs as the nuclear program evolves; Funding and financing short- and long-term Human Resource Development efforts

  10. Tropical Journal of Pharmaceutical Research: Editorial Policies

    African Journals Online (AJOL)

    The Tropical Journal of Pharmaceutical Research is an Open Access international ... Although primarily devoted to original research papers, the journal ... know so that we can keep the authors informed and, where necessary, find alternatives. ..... An example of how a search strategy should be presented can be seen in the ...

  11. [Pharmaceutical chemistry of drug-initiated photosensitivity].

    Science.gov (United States)

    Rácz, Ákos; Tóth, Lívia

    2015-01-01

    The photosensitivity originated from drugs is a common problem in medical and pharmaceutical practice. It is of prominent importance in drug development and in regulatory issues. The photosensitizer effect of drug substances is determined by their chemical structures, and it mainly originates from aromatic chromophore systems and photo-dissociable bonds forming free radicals. The photodegradation may happen in many different types of chemical reaction pathways. Our aim is to demonstrate in this review the interrelations between structure and photodegradation. We show examples for the different reaction types, with drugs from different pharmacologic therapeutic classes. The in vivo chemical reactivity of photodegradates of pharmaceutical substances, the in vitro methods of investigation for testing photoreactivity and phototoxicity, and briefly the clinical tests for photosensitivity disorders are also discussed.

  12. Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality

    National Research Council Canada - National Science Library

    Mossialos, Elias; Mrazek, M. F; Walley, T; Mossialos, E

    2004-01-01

    ... Breckenridge, Chairman of the Medicines and Healthcare Products Regulatory Agency, United Kingdom The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of ...

  13. An assessment of pharmaceutical waste management in some ...

    African Journals Online (AJOL)

    Thirty four (34) of the fifty (50) selected Nigerian based pharmaceutical businesses, mainly acting as local manufacturers and major importers of medicines were interviewed using questionnaires to ascertain their waste management practices, knowledge of waste management policies and subjection to regulatory control.

  14. Legal considerations for social media marketing by pharmaceutical industry.

    Science.gov (United States)

    Yang, Y Tony; Chen, Brian

    2014-01-01

    Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

  15. The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries.

    Science.gov (United States)

    Oortwijn, Wija; Mathijssen, Judith; Banta, David

    2010-05-01

    Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage. We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA. All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation. The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

  16. A case study in experiential learning: pharmaceutical cold chain management on wheels.

    Science.gov (United States)

    Vesper, James; Kartoglu, Ümit; Bishara, Rafik; Reeves, Thomas

    2010-01-01

    People who handle and regulate temperature-sensitive pharmaceutical products require the knowledge and skills to ensure those products maintain quality, integrity, safety, and efficacy throughout their shelf life. People best acquire such knowledge and skills through "experiential learning" that involves working with other learners and experts. The World Health Organization developed a weeklong experiential learning event for participants so they could gain experience in how temperature-sensitive products are handled, stored, and distributed throughout the length of the distribution supply chain system. This experiential learning method enabled participants to visit, critically observe, discuss and report on the various components of the cold chain process. An emphasis was placed on team members working together to learn from one another and on several global expert mentors who were available to guide the learning, share their experiences, and respond to questions. The learning event, Pharmaceutical Cold Chain Management on Wheels, has been conducted once each year since 2008 in Turkey with participants from the global pharmaceutical industry, health care providers, national regulatory authorities, and suppliers/vendors. Observations made during the course showed that it was consistent with the principles of experiential and social learning theories. Questionnaires and focus groups provided evidence of the value of the learning event and ways to improve it. Reflecting the critical elements derived from experiential and social learning theories, five factors contributed to the success of this unique experiential learning event. These factors may also have relevance in other experiential learning courses and, potentially, for experiential e-learning events.

  17. [Fourcroy and pharmaceutical journals].

    Science.gov (United States)

    Bonnemain, Bruno

    2011-04-01

    Cadet de Gassicourt wrote a brief Eloge of Fourcroy in January 1810 as he died in December of 1809. Fourcroy had a major role concerning the new ideas on the place of pharmacy at the beginning of the 19th century. Fourcroy has had a key influence for the start of several pharmaceutical journals that wanted to emphasize the link between the new chemistry and pharmacy. None of these journals created with him will survive and one has to wait for 1909 to see the creation, without Fourcroy, of a new pharmaceutical journal, the "Journal de Pharmacie" that will become "Journal de Pharmacie et des Sciences accessoires", then "Journal de Pharmacie et de Chimie", before taking the name of"Annales Pharmaceutiques Françaises", the present official journal of the French Academy of Pharmacy. In spite of the essential role of Fourcroy at the start of pharmaceutical journals, Cadet did not even mention it in his Eloge of 1810.

  18. Rheology in Pharmaceutical Sciences

    DEFF Research Database (Denmark)

    Aho, Johanna; Hvidt, Søren; Baldursdottir, Stefania

    2016-01-01

    Rheology is the science of flow and deformation of matter. Particularly gels and non-Newtonian fluids, which exhibit complex flow behavior, are frequently encountered in pharmaceutical engineering and manufacturing, or when dealing with various in vivo fluids. Therefore understanding rheology......, together with the common measurement techniques and their practical applications. Examples of the use of rheological techniques in the pharmaceutical field, as well as other closely related fields such as food and polymer science, are also given....... is important, and the ability to use rheological characterization tools is of great importance for any pharmaceutical scientist involved in the field. Flow can be generated by shear or extensional deformations, or a combination of both. This chapter introduces the basics of both shear and extensional rheology...

  19. Sex, gender, and pharmaceutical politics: From drug development to marketing.

    Science.gov (United States)

    Fisher, Jill A; Ronald, Lorna M

    2010-08-01

    Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and

  20. Diagnostic and therapeutic radio pharmaceutical capsules

    International Nuclear Information System (INIS)

    Haney, T.A.; Wedeking, P.W.; Morcos, N.A.

    1981-01-01

    An improved pharmaceutical radioactive capsule consisting of a non-toxic, water soluble material adapted to being ingested and rapidly disintegrating on contact with fluids of the gastro-intestinal tract is described. Each capsule is provided with filler material supporting a pharmaceutically useful radioactive compound absorbable from the gastro-intestinal tract. The capsule is preferably of gelatin, methyl cellulose or polyvinyl alcohol and the filler is a polyethylene glycol. The radioactive compound may be iodine e.g. sodium radioiodide I-131 or 123. The capsule may also contain a reducing agent e.g. sodium thiosulphate, sulphite, or bisulphite. (author)

  1. Conceptualizing Pharmaceutical Plants

    DEFF Research Database (Denmark)

    Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel

    2006-01-01

    In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models...... is a complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....

  2. Author Details

    African Journals Online (AJOL)

    Odeniyi, MA. Vol 14, No 2 (2011) - Articles Evaluation of bioadhesive properties of natural and modified banana starches. Abstract PDF · Vol 15, No 1 (2012) - Articles Evaluation of Pharmaceutical and Chemical Equivalence of Selected Brands of Diclofenac Sodium Tablets Abstract PDF · Vol 15, No 3 (2012) - Articles

  3. Author Details

    African Journals Online (AJOL)

    Adegoke, OA. Vol 12, No 1 (2009) - Articles Colorimetric Assay Of Naproxen Tablets by Derivatization Using 4-Carboxyl-2,6-Dinitrobenzene Diazonium Ion Abstract PDF · Vol 12, No 3 (2009) - Articles Generic versus innovator: Analysis of the pharmaceutical qualities of paracetamol and ibuprofen. Abstract PDF. ISSN: 1026- ...

  4. Pharmaceutical strategy and innovation: an academics perspective.

    Science.gov (United States)

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences.

  5. New Product Introduction in the Pharmaceutical Industry

    DEFF Research Database (Denmark)

    Hansen, Klaus Reinholdt Nyhuus

    Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials...... is unknown and negotiations with authorities have become harder, making market introduction more difficult. This dissertation treats the new product introduction process in the pharmaceutical industry from an operations perspective. The overarching aim of this dissertation is to improve the planning...... uncertainty and several important industry characteristics. The model is used to gain several insights on the use of risk packaging and on keeping time-to-market short. As capacity in secondary pharmaceutical production is critical for product availability, a capacity planning model for a new drug delivery...

  6. On radiation treatment of pharmaceutical products

    International Nuclear Information System (INIS)

    Zukov, V.; Mende, V.

    1976-01-01

    The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)

  7. Pharmaceutical packaging handbook

    National Research Council Canada - National Science Library

    Bauer, Edward J

    2009-01-01

    ... of the modern world. Pharmaceutical products and health care in developing countries and remote parts of the world seems like magic. Diseases that were once fatal and chronic conditions that destroyed lives have slowly been conquered by modern medicine. Views of the body, unimaginable for most of the last century with X rays, are now possible with new i...

  8. Doctors and pharmaceutical industry.

    Science.gov (United States)

    Beran, Roy G

    2009-09-01

    The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

  9. The Effectiveness of Pharmaceutical Marketing

    NARCIS (Netherlands)

    E.R. Kappe

    2011-01-01

    textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to

  10. Regulating pharmaceutical advertising: what will work?

    Science.gov (United States)

    Shapiro, M F

    1997-02-01

    As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.

  11. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Journal Homepage Image. We seek to encourage pharmaceutical and allied research of tropical and international relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and the healthcare professionals. We publish articles in pharmaceutical sciences and related ...

  12. The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs.

    Science.gov (United States)

    Ravinetto, Raffaella; Roosen, Tim; Dujardin, Catherine

    2018-01-01

    Today, a combination of globalization of pharmaceutical production, lack of regulatory harmonization, and weakness of Medicines Regulatory Authorities, creates the "perfect conditions" for poor-quality medicine to circulate in the global market and to penetrate the less-regulated countries. Medicines regulation is the responsibility of the national regulatory authorities in the recipient country, but in the poorer countries, in practice, the responsibility of supply of quality-assured medicines is often taken by Non-Governmental Organizations and other implementers. But with some notable exceptions, many donors lack a pharmaceutical procurement policy with adequate quality requirements; and many implementers lack the skills and expertise needed to orient themselves in the complex web of global pharmaceutical supply. Thus, patients served by humanitarian or development programs may remain exposed to the risk of poor-quality medicines. When public money is used to purchase medicines for medical programs to be carried out overseas, adequate policies should be in place to assure that the same quality requirements are set that would be required for medicines marketed in the "donor" country. We will describe here a policy recently adopted in Belgium, i.e. the "Commitment to Quality Assurance for Pharmaceutical Products", signed in October 2017 by the Vice Prime Minister and Minister for Development Cooperation and 19 Belgian implementing agencies. By signing the new policy, the counterparts committed to ensure quality of medicines in the programs funded by Belgium's Official Development Assistance, and to build quality-assurance capacity in the recipient countries. Implementers are requested to integrate in their financing applications a section for pharmaceutical quality assurance, with a justified budget. They are also invited to consider how costs could be rationalized and mutualized by aligning the strengths of the various implementers. This model policy has the

  13. PHARMACEUTICAL COMPANIES BETWEEN CRISIS AND COMPETITIVENESS - SECTORAL DIAGNOSIS

    Directory of Open Access Journals (Sweden)

    Mihaela\tBÎRSAN

    2015-06-01

    Full Text Available The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the recent health policies implemented by newly industrialized countries that are aimed at ensuring increased access to care. Analysts see the field phenomenon called "Farma-merger" a good chance for European pharmaceutical companies oriented to developing countries where drug sales should record a double-digit annual growth until 2017. In Erste Group reports stated that the impact of the crisis on the pharmaceutical industry should be limited markets for EU only their economic slowdown. This will be possible because the external indebtedness of pharmaceutical companies in the EU remains at a minimum, they are able to finance their investment plans without tapping financial markets, are not adversely affected by the current limited availability of credit resources. Therefore major pharmaceutical companies in the EU will remain a solid investment on the long term, the negative developments are limited due to high resistance to the crisis their business model segment "generic". The consequence of these developments is reflected in the recognition for the first time, the pharmaceutical sector as a strategic sector for the Romanian economy. In the context of public debate launching the National Strategy for Competitiveness 2014-2020, Generic Medicines Industry Association of Romania (APMGR local pharmaceutical industry reminds the Government proposals on correcting the current fiscal and operational regulatory framework, to allow unlocking investments in facilities

  14. [Written pharmaceutical advertising--still unreliable?].

    Science.gov (United States)

    Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars

    2014-09-02

    Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.

  15. EU pharmaceutical expenditure forecast.

    Science.gov (United States)

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them

  16. Challenges in Translational Development of Pharmaceutical Cocrystals.

    Science.gov (United States)

    Kale, Dnyaneshwar P; Zode, Sandeep S; Bansal, Arvind K

    2017-02-01

    The last 2 decades have witnessed increased research in the area of cocrystals resulting in deeper scientific understanding, increase in intellectual property landscape, and evolution in the regulatory environment. Pharmaceutical cocrystals have received significant attention as a new solid form on account of their ability to modulate poor physicochemical properties of drug molecules. However, pharmaceutical development of cocrystals could be challenging, thus limiting their translation into viable drug products. In the present commentary, the role of cocrystals in the modulation of material properties and challenges involved in the pharmaceutical development of cocrystals have been discussed. The major hurdles encountered in the development of cocrystals such as safety of coformers, unpredictable performance during dissolution and solubility in different media, difficulties in establishing in vitro-in vivo correlation, and polymorphism have been extensively discussed. The influence of selecting appropriate formulation and process design on these challenges has been discussed. Finally, a brief outline of cocrystals that are undergoing clinical development has also been presented. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  17. Pharmaceutical market in Serbia

    Directory of Open Access Journals (Sweden)

    Veselin Tima Dickov

    2012-02-01

    Full Text Available Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmaceutical product. A special challenge that the subject raises is the existence of controversy generated from two sources. Marketing controversy stems from criticism leveled at the effectiveness and efficiency of marketing activities and the debatable ethical code of conduct. [J Intercult Ethnopharmacol 2012; 1(1.000: 44-51

  18. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    Science.gov (United States)

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  19. Pharmaceutical Research Strategies

    OpenAIRE

    Phlippen, Sandra; Vermeersch, Ad

    2008-01-01

    textabstractThis study analyses 1400 research projects of the top 20 R&D-spending pharmaceuticals to identify the determinants of successful research projects. We provide clear evidence that externally sourced projects and projects involving biotechnologies perform better than internal projects and chemical projects, respectively. Controlling for these effects, we find that big pharma should either build a critical mass of disease area knowledge or diversify projects over different DA’s in or...

  20. Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil.

    Science.gov (United States)

    Li, W C

    2014-04-01

    With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. [The pharmaceutical market in Mexico: size, value, and concentration].

    Science.gov (United States)

    Torres Guerra, Sandra; Gutiérrez, Juan Pablo

    2009-07-01

    To describe the pharmaceutical drug market in Mexico in terms of its size, structure, business' market power, and consumer negotiating power. A descriptive study based on data from the 2004 Economics Census and the reports of IMS Health, Inc. (Norwalk, Connecticut, United States of America). Sales amounts and volumes of Mexico's pharmaceutical companies from 2002-2005 were obtained and the Herfindahl-Hirschman Index (HHI) and its inverse were calculated as indicators of the market's degree of concentration; also, price elasticity was determined by a product index. The total value of the products manufactured by the pharmaceutical sector was 115 billion in 2006 Mexican pesos, of which 99% pertained to companies categorized as large. This amount constituted 1.2% of the national gross domestic product that year (20.0% of the health sector's portion, estimated to be 6.0%) and 3.9% of the total value of manufactured goods. The HHI of Mexico's pharmaceutical market during the study period was about 0.04, albeit with a steady decline, and its inverse decreased from 23 to 26. The price elasticity of pharmaceutical products was minimal (0.007, 0.003, and -0.002). This study constitutes a preliminary description of Mexico's pharmaceutical market, one of the country's most dynamic economic sectors. It confirmed that the market is a rigid oligopoly, and thus supports enactment of firmer regulatory tools to reduce the power of the manufacturers in favor of that of the consumers.

  2. Global pharmaceutical regulation: the challenge of integration for developing states.

    Science.gov (United States)

    Pezzola, Anthony; Sweet, Cassandra M

    2016-12-20

    This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state's institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in

  3. [Logistics in the pharmaceutical service].

    Science.gov (United States)

    Stanko, P; Fulmeková, M

    2005-11-01

    The conception of the field of pharmaceutical service defines pharmaceutical service as the basic part of pharmacy, the principal task of which is to provide pharmaceutical care as an inseparable part of providing health care. It represents a set of professional activities of the pharmacist oriented to securing human and veterinary pharmaceutical products and health care products and to optimising effective, safe and quality pharmacotherapy. Technically, pharmaceutical service is an applied discipline, as it makes use of knowledge gained in other pharmaceutical, medical, psychological, social, and economic sciences. Because of its interdisciplinary character it is necessary to extend the theory of pharmaceutical service in such a way so that it may reflect all aspects of its sphere of activity. One of the possibilities is to define the pharmacy premises as an independent functional unit which operates on the basis of valid legal standards in such a way that on the one hand it secures the provision of health (pharmaceutical) care, and on the other hand it maintains its cost-effectiveness. To keep the quality of care of the patient and the economic aspect in balance, it is necessary to define the term pharmaceutical logistics also under the conditions of Slovak (Czech) pharmacy as early satisfaction of the requirements of the patient (client) in the pharmacy premises, which means that the appropriate pharmaceutical product or health care product and the appropriate information must be at the right time in the required amount and required quality in the right place.

  4. Knowledge Sharing as a Social Dilemma in Pharmaceutical Innovation.

    Science.gov (United States)

    Kim, Daria

    This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors’ innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection of primary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of scientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem of appropriability of drug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules of access should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the “cooperative choice” (i.e., when everyone shares data) becomes the “dominant strategy.” This can be achieved only when access is

  5. Resumed Publication of Pharmaceuticals in 2009

    Directory of Open Access Journals (Sweden)

    Shu-Kun Lin

    2009-04-01

    Full Text Available After a five year hiatus, we are pleased to announce the resumption of publication of the MDPI journal Pharmaceuticals (ISSN 1424-8247. First launched in 2004, few suitable papers were submitted and only one was published [1], before our limited editorial resources at the time led us to temporarily discontinue publication. Several things have changed since then. First, there has been an explosive growth in the number of manuscripts submitted and published in MDPI’s various current journals [2], whose topics clearly fall within the intended scope of Pharmaceuticals and we feel that these manuscripts merit a dedicated forum. Second, the expansion of MDPI, now with Editorial Offices and staff in Basel (Switzerland and Beijing (China, allows us to provide Pharmaceuticals’ authors with all the services they could desire and deserve: a simple manuscript submission process, rigorous peer review, quick revision turnaround, Open Access publication on a new and attractive platform and coverage by all the major abstracting services. In addition, a new Editorial Board comprised of noted academic and industry scientists has been set up for Pharmaceuticals. Finally, to better focus the subject matter published in Pharmaceuticals on molecular medicines, we have also set up a special section in International Journal of Molecular Sciences (IJMS, ISSN 1422-0067 for papers on nutraceuticals or chemopreventives. We look forward to receiving and publishing your papers and as always, we welcome your comments and suggestions.

  6. Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil

    International Nuclear Information System (INIS)

    Li, W.C.

    2014-01-01

    With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. - Highlights: • The sources of pharmaceutical residuals are studied. • Occurrence and fate of pharmaceutical in environment are studied. • Risk management and recommendation are provided on pharmaceutical pollution. - Concentration of pharmaceuticals in the natural environment is lower than in effluent of sewage treatment plants in which carbamazepine is found frequently in soil and water body

  7. Author Details

    African Journals Online (AJOL)

    Yilma, KM. Vol 9, No 1 (2015) - Articles The Internet and Regulatory Responses in Ethiopia: Telecoms, Cybercrimes, Privacy, E-commerce, and the New Media Abstract PDF · Vol 9, No 1 (2015) - Articles The Internet and Ethiopias IP Law, Internet Governance and Legal Education: An Overview Abstract PDF. ISSN: 1998- ...

  8. Author Details

    African Journals Online (AJOL)

    Review of Policy, Regulatory, and Organizational Frameworks of Environment and Health in Ethiopia Abstract PDF · Vol 30, No 1 (2016): Special Issue - Articles Health Effects of Environmental Exposures, Occupational Hazards and Climate Change in Ethiopia: Synthesis of Situational Analysis, Needs Assessment and the ...

  9. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    International Nuclear Information System (INIS)

    Zanette, Camila; Melero, Laura T.U.H.; Araujo, Elaine B. de; Mengatti, Jair; Silva, Katia S. de S.

    2011-01-01

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  10. 3. Radioactive pharmaceutical medications

    International Nuclear Information System (INIS)

    2006-01-01

    In the chapter common definitions of for radio-pharmacy are given. Radio-pharmacy medications are pharmacy medications which contain minor amount of one or several radionuclides (radioactive tracers), those radiation ability is applying in diagnostic or therapeutic purposes. At the same time radionuclides with more short life time, which are ether gamma-radiators or beta-radiators are applying. The following items for such radioisotopes production; radionuclides applying in nuclear medicine; radio-pharmaceutics; radio-toxicity; quality insurance; order for 18 F-PDG production; radionuclide analysis are considered

  11. Regulation of Pharmaceutical Prices

    DEFF Research Database (Denmark)

    Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas

    On April 1, 2005, Denmark changed the way references prices, a main determinant of reimbursements for pharmaceutical purchases, are calculated. The previous reference prices, which were based on average EU prices, were substituted to minimum domestic prices. Novel to the literature, we estimate...... the joint eects of this reform on prices and quantities. Prices decreased more than 26 percent due to the reform, which reduced patient and government expenditures by 3.0 percent and 5.6 percent, respectively, and producer revenues by 5.0 percent. The prices of expensive products decreased more than...

  12. Electrochemical biosensors in pharmaceutical analysis

    OpenAIRE

    Gil, Eric de Souza; Melo, Giselle Rodrigues de

    2010-01-01

    Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...

  13. Effluent treatment plant for pharmaceutical unit at Bahipheru - case study

    International Nuclear Information System (INIS)

    Hayat, A.

    1997-01-01

    This project has been awarded to environ (Pvt) Ltd., on turnkey basis, and is an integrated waste treatment facility for pharmaceuticals companies, manufacturing paracetamole, aspirin and various pharmaceuticals intermediates, from phenol as basic raw material. A highly toxic waste water, containing high concentrations of phenolics and sulfate ions is generated at this plant and has to be treatment before final disposal into an irrigation channel. (author)

  14. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    Energy Technology Data Exchange (ETDEWEB)

    Razem, D; Katusin-Razem, B [Institut Rudjer Boskovic, Zagreb (Yugoslavia); Starcevic, M; Galekovic, B [PLIVA Pharmaceutical Works, Zagreb (Yugoslavia)

    1990-01-01

    The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author).

  15. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    International Nuclear Information System (INIS)

    Razem, D.; Katusin-Razem, B.; Starcevic, M.; Galekovic, B.

    1990-01-01

    The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)

  16. Ethical pharmaceutical promotion and communications worldwide: codes and regulations

    Science.gov (United States)

    2014-01-01

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

  17. Pharmaceutical cocrystals: the coming wave of new drug substances.

    Science.gov (United States)

    Brittain, Harry G

    2013-02-01

    Solid crystalline phases containing two cocrystallized components offer a new development pathway whereby one can potentially improve the physical characteristics (i.e., equilibrium solubility, dissolution rate, solid-state stability, etc.) of a drug substance that exhibits a profile that is less than desirable. In this commentary, the topic of pharmaceutical cocrystals will be briefly explored, and a short exposition of the solubility and dissolution rate advantages that have been realized in various systems will be provided. The Guidance for Industry document recently proposed by United States Food and Drug Administration will be outlined, and its requirements explained. Finally, the subset of pharmaceutical cocrystals that consist of a drug substance and a salt of that substance (termed a salt cocrystal) will be examined to illustrate this additional class of pharmaceutical cocrystals that may offer significant scientific and regulatory advantages. Copyright © 2012 Wiley Periodicals, Inc.

  18. Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

    Science.gov (United States)

    Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

    2014-03-29

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

  19. [Pharmaceutical advice concerning different pharmaceutical dosage forms].

    Science.gov (United States)

    Szakonyi, Gergely; Zelkó, Romána

    2010-01-01

    The present paper summarizes the commonly applied types of drug uptake and the pharmacists' advice concerning a certain dosage form. The manuscript also deals with the modified release dosage forms and their abbreviations in the name of the marketing authorized products.

  20. Recombinant biologic products versus nutraceuticals from plants – a regulatory choice?

    Science.gov (United States)

    Drake, Pascal M. W.; Szeto, Tim H.; Paul, Mathew J.; Teh, Audrey Y.‐H.

    2016-01-01

    Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regulatory path for such new pharmaceuticals has been a deterrent. Consideration has been given to using alternative regulatory paths, including those for nutraceuticals or cosmetic agents. This review will consider these possibilities, and discuss the difficulties in establishing regulatory guidelines for new pharmaceutical manufacturing technologies. PMID:27297459

  1. Author Details

    African Journals Online (AJOL)

    PROMOTING ACCESS TO AFRICAN RESEARCH. AFRICAN JOURNALS ONLINE (AJOL) · Journals · Advanced Search · USING AJOL · RESOURCES. Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads.

  2. Author Correction

    DEFF Research Database (Denmark)

    Gröbner, Susanne N; Worst, Barbara C; Weischenfeldt, Joachim

    2018-01-01

    In this Article, author Benedikt Brors was erroneously associated with affiliation number '8' (Department of Developmental Neurobiology, St Jude Children's Research Hospital, Memphis, Tennessee, USA); the author's two other affiliations (affiliations '3' and '7', both at the German Cancer Researc...

  3. Author Details

    African Journals Online (AJOL)

    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... An algorithm to retrieve Land Surface Temperature using Landsat-8 Dataset Abstract PDF. ISSN: 2225-8531.

  4. Radiation sterilization of pharmaceuticals and polymers

    International Nuclear Information System (INIS)

    Gopal, N.G.S.

    1978-01-01

    Radiation, in the form of high energy electrons as well as gamma radiation, has featured in the last 15 yr as a promising sterilization agent for many heat sensitive and ethylene oxide incompatible pharmaceuticals and polymers of medical usage. This article deals with (i) a comparison of the various methods of sterilization and their shortcomings, (ii) modes of interaction of radiation with matter, (iii) the types of radiation sources in common use, (iv) dosimetry, (v) dose rate effect, (vi) a literature survey of the radiation effect on pharmaceuticals in solid form as well as in aqueous solution and on polymers in the form of plastic medical products and (vii) the evaluation of the irradiated products. The effect of dose rate on the stability of these materials is emphasized. Either very little work has been done on the dose rate effect or the published information is scanty. The literature survey covers the recent period of 5 to 6 years. (author)

  5. NMR imaging and pharmaceutical sciences

    International Nuclear Information System (INIS)

    Beall, P.T.; Good, W.R.

    1986-01-01

    Described is the technique of NMR-imaging in diagnostic medicine. Proton and phosphorus NMR in diagnosis of abnormal tissue pathology. Discussed is the value of NMR to the pharmaceutical sciences. NMR may play an important role in monitoring the response of tissues to drugs, determining the localization of drugs, performing real time pharmacokinetics and testing the use of NMR contrast pharmaceuticals

  6. PSE in Pharmaceutical Process Development

    DEFF Research Database (Denmark)

    Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John

    2011-01-01

    The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...

  7. Recent regulatory issues in Finland

    International Nuclear Information System (INIS)

    Laaksonen, J.; Tiipana, P.

    2001-01-01

    This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

  8. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas

    Directory of Open Access Journals (Sweden)

    Varley Dias Sousa

    Full Text Available ABSTRACT Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs and Regional Reference Authorities (RRAs. This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report as tools for strengthening health systems. Based on a narrative (nonsystematic review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data and data- and work-sharing (inter-agency data. The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1 the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics and 2 the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

  9. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

    Science.gov (United States)

    Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

    2016-05-01

    Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

  10. Horizon Scanning for Pharmaceuticals

    DEFF Research Database (Denmark)

    Lepage-Nefkens, Isabelle; Douw, Karla; Mantjes, GertJan

    for a joint horizon scanning system (HSS).  We propose to create a central “horizon scanning unit” to perform the joint HS activities (a newly established unit, an existing HS unit, or a third party commissioned and financed by the collaborating countries). The unit will be responsible for the identification...... and filtration of new and emerging pharmaceutical products. It will maintain and update the HS database, organise company pipeline meetings, and disseminate the HSS’s outputs.  The HS unit works closely together with the designated national HS experts in each collaborating country. The national HS experts...... will collect country-specific information, liaise between the central HS unit and country-specific clinical and other experts, coordinate the national prioritization process (to select products for early assessment), and communicate the output of the HSS to national decision makers.  The outputs of the joint...

  11. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  12. Pharmaceutical advertising in emergency departments.

    Science.gov (United States)

    Marco, Catherine A

    2004-04-01

    Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.

  13. Qualitative insights into promotion of pharmaceutical products in Bangladesh: how ethical are the practices?

    Science.gov (United States)

    Mohiuddin, Mahrukh; Rashid, Sabina Faiz; Shuvro, Mofijul Islam; Nahar, Nahitun; Ahmed, Syed Masud

    2015-12-01

    The pharmaceutical market in Bangladesh is highly concentrated (top ten control around 70 % of the market). Due to high competition aggressive marketing strategies are adopted for greater market share, which sometimes cross limit. There is lack of data on this aspect in Bangladesh. This exploratory study aimed to fill this gap by investigating current promotional practices of the pharmaceutical companies including the role of their medical representatives (MR). This qualitative study was conducted as part of a larger study to explore the status of governance in health sector in 2009. Data were collected from Dhaka, Chittagong and Bogra districts through in-depth interview (healthcare providers and MRs), observation (physician-MR interaction), and round table discussion (chief executives and top management of the pharmaceutical companies). Findings reveal a highly structured system geared to generate prescriptions and ensure market share instituted by the pharmaceuticals. A comprehensive training curriculum for the MRs prepares the newly recruited science graduates for generating enough prescriptions by catering to the identified needs and demands of the physicians expressed or otherwise, and thus grab higher market-share for the companies they represent. Approaches such as inducements, persuasion, emotional blackmail, serving family members, etc. are used. The type, quantity and quality of inducements offered to the physicians depend upon his/her capacity to produce prescriptions. The popular physicians are cultivated meticulously by the MRs to establish brand loyalty and fulfill individual and company targets. The physicians, willingly or unwillingly, become part of the system with few exceptions. Neither the regulatory authority nor the professional or consumer rights bodies has any role to control or ractify the process. The aggressive marketing of the pharmaceutical companies compel their MRs, programmed to maximize market share, to adopt unethical means if

  14. Buddhism and neuroethics: the ethics of pharmaceutical cognitive enhancement.

    Science.gov (United States)

    Fenton, Andrew

    2009-08-01

    This paper integrates some Buddhist moral values, attitudes and self-cultivation techniques into a discussion of the ethics of cognitive enhancement technologies - in particular, pharmaceutical enhancements. Many Buddhists utilize meditation techniques that are both integral to their practice and are believed to enhance the cognitive and affective states of experienced practitioners. Additionally, Mahāyāna Buddhism's teaching on skillful means permits a liberal use of methods or techniques in Buddhist practice that yield insight into our selfnature or aid in alleviating or eliminating duhkha (i.e. dissatisfaction). These features of many, if not most, Buddhist traditions will inform much of the Buddhist assessment of pharmaceutical enhancements offered in this paper. Some Buddhist concerns about the effects and context of the use of pharmaceutical enhancements will be canvassed in the discussion. Also, the author will consider Buddhist views of the possible harms that may befall human and nonhuman research subjects, interference with a recipient's karma, the artificiality of pharmaceutical enhancements, and the possible motivations or intentions of healthy individuals pursuing pharmacological enhancement. Perhaps surprisingly, none of these concerns will adequately ground a reflective Buddhist opposition to the further development and continued use of pharmaceutical enhancements, either in principle or in practice. The author argues that Buddhists, from at least certain traditions - particularly Mahāyāna Buddhist traditions - should advocate the development or use of pharmaceutical enhancements if a consequence of their use is further insight into our self-nature or the reduction or alleviation of duhkha.

  15. Nonclinical statistics for pharmaceutical and biotechnology industries

    CERN Document Server

    2016-01-01

    This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...

  16. Modern principles of public administration of pharmaceutical supply for the population in emergency situations

    Directory of Open Access Journals (Sweden)

    P. V. Olіynуk

    2015-08-01

    Full Text Available In conditions of the emergency situations’ amount increasing the readiness of the state to provide affected people and all other segments of the population with full pharmaceutical provision is important. The aim of research is an analysis of the state of the legislative and regulatory framework of governmental administration by pharmaceutical provision of the population in the conditions of emergency situations. Materials and methods. We used methods of observation and synthesis, generalization and formalization, analysis of content. The object of the study were regulations, government pharmaceutical providing of population in emergency situations. Results. Studies show the need to develop methods and principles of public administration process to ensure people with pharmaceutical and specific methodological approaches in emergency situations. Conclusions. It has been established, that it is necessary to develop scientifically based methods of governance by the process of pharmaceutical providing the affected population.

  17. The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals.

    Science.gov (United States)

    Lewen, Nancy

    2011-06-25

    The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.

  18. Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

    Science.gov (United States)

    Morton, Daniel; Sistare, Frank D; Nambiar, Prashant R; Turner, Oliver C; Radi, Zaher; Bower, Nancy

    2014-07-01

    International regulatory and pharmaceutical industry scientists are discussing revision of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) S1 guidance on rodent carcinogenicity assessment of small molecule pharmaceuticals. A weight-of-evidence approach is proposed to determine the need for rodent carcinogenicity studies. For compounds with high human cancer risk, the product may be labeled appropriately without conducting rodent carcinogenicity studies. For compounds with minimal cancer risk, only a 6-month transgenic mouse study (rasH2 mouse or p53+/- mouse) or a 2-year mouse study would be needed. If rodent carcinogenicity testing may add significant value to cancer risk assessment, a 2-year rat study and either a 6-month transgenic mouse or a 2-year mouse study is appropriate. In many cases, therefore, one rodent carcinogenicity study could be sufficient. The rasH2 model predicts neoplastic findings relevant to human cancer risk assessment as well as 2-year rodent models, produces fewer irrelevant neoplastic outcomes, and often will be preferable to a 2-year rodent study. Before revising ICH S1 guidance, a prospective evaluation will be conducted to test the proposed weight-of-evidence approach. This evaluation offers an opportunity for a secondary analysis comparing the value of alternative mouse models and 2-year rodent studies in the proposed ICH S1 weight-of-evidence approach for human cancer risk assessment. © 2014 by The Author(s).

  19. Pharmaceuticals and Their Impact on the Environment

    Directory of Open Access Journals (Sweden)

    Tomić, S

    2010-07-01

    Full Text Available Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07 and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08.

  20. [Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

    Science.gov (United States)

    Dzhalilova, K I

    2009-11-01

    Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

  1. Author's capabilities in author indexing

    International Nuclear Information System (INIS)

    Ooi, Shoichi

    1988-01-01

    The purpose of this paper is to provide a author capability of current author indexing practices in journal literature indexing practices in 'Journal of Nuclear Science and Technology of Japan'. This Journal employed keywords freely assigned by author and not taken from INIS Thesaurus or other vocabulary list. Author examined 413 literatures, comparing keywords assigned by the literatures' authors with descriptor's (ATOMINDEX) assigned by an experienced professional indexer. The results of the comparisons showed that the average set of terms assigned by author included about 70% of all the terms assigned to the same literature by the professional indexer. Authors eventually would contribute, for the most effective point to create reference to information is at the time of its generation. Consequently, it may be possible to transfer them easily to descriptors in every secondary information system. (author)

  2. Regulatory analysis on the medical use of ephedrine-related products in Taiwan

    Directory of Open Access Journals (Sweden)

    Wan-Nan Yu

    2018-04-01

    Full Text Available To prevent ephedrine-related products from being misused to produce amphetamine and/or its analogs, there's a need for more effective and achievable regulatory mechanisms for the health, police, investigational, prosecution and judiciary authorities in Taiwan. This review was conducted to evaluate the international and Taiwan's regulatory policies and management of medical ephedrine-related products through the corresponding information collected from international and Taiwan government agency authorities. The combat of illegal drugs should involve both supply and demand sides to be successful. Health authorities in Taiwan do not have the investigational power to manage the forbidden transformation, abusing and manufacture of the illegal drugs from ephedrine-related products. Take the judicial interventions in the United States and in Japan as the examples, the organizational cooperation in Taiwan can be one of the main key strategies to combat against illegal drugs from ephedrine-related products. It is necessary to integrate the judicial, police and health agencies to prevent the production of illegal drugs from the ephedrine-related products in Taiwan. The efforts and regulatory control measures should be integrated to speed up the collaboration between different government authorities. It might be achieved through reorganization involving Taiwan Food and Drug Administration. Keywords: Ephedrine-related products, Taiwan Food and Drug Administration (TFDA, Controlled Drugs Act, Pharmaceutical Affairs Act, Pharmacists Act

  3. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  4. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

    Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

  5. System-wide hybrid MPC-PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction.

    Science.gov (United States)

    Singh, Ravendra; Ierapetritou, Marianthi; Ramachandran, Rohit

    2013-11-01

    The next generation of QbD based pharmaceutical products will be manufactured through continuous processing. This will allow the integration of online/inline monitoring tools, coupled with an efficient advanced model-based feedback control systems, to achieve precise control of process variables, so that the predefined product quality can be achieved consistently. The direct compaction process considered in this study is highly interactive and involves time delays for a number of process variables due to sensor placements, process equipment dimensions, and the flow characteristics of the solid material. A simple feedback regulatory control system (e.g., PI(D)) by itself may not be sufficient to achieve the tight process control that is mandated by regulatory authorities. The process presented herein comprises of coupled dynamics involving slow and fast responses, indicating the requirement of a hybrid control scheme such as a combined MPC-PID control scheme. In this manuscript, an efficient system-wide hybrid control strategy for an integrated continuous pharmaceutical tablet manufacturing process via direct compaction has been designed. The designed control system is a hybrid scheme of MPC-PID control. An effective controller parameter tuning strategy involving an ITAE method coupled with an optimization strategy has been used for tuning of both MPC and PID parameters. The designed hybrid control system has been implemented in a first-principles model-based flowsheet that was simulated in gPROMS (Process System Enterprise). Results demonstrate enhanced performance of critical quality attributes (CQAs) under the hybrid control scheme compared to only PID or MPC control schemes, illustrating the potential of a hybrid control scheme in improving pharmaceutical manufacturing operations. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

    This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

  7. Between pharmaceutical patents and European patients: is a compromise still possible?

    Science.gov (United States)

    Garattini, Livio; Padula, Anna

    2017-10-01

    Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.

  8. Regulatory point of view of SAT application

    International Nuclear Information System (INIS)

    Juhasz, L.

    2002-01-01

    I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)

  9. Cyclodextrins as drug carriers in Pharmaceutical Technology: The state of the art.

    Science.gov (United States)

    Conceição, Jaime; Adeoye, Oluwatomide; Cabral-Marques, Helena Maria; Lobo, Jose Manuel Sousa

    2017-12-18

    Cyclodextrins (CDs) are versatile excipients with an essential role in drug delivery, as they can form non-covalently bonded inclusion complexes (host-guest complexes) with several drugs either in solution or in the solid state. The main purpose of this publication was to carry out a state of the art of CDs as complexing agents in drug carrier systems. In this way, the history, properties and pharmaceutical applications of the CDs were highlighted with typical examples. The methods to enhance the complexation efficiency (CE) and the CDs applications in solid dosage forms were emphasized in more detail. The main advantages of using these cyclic oligosaccharides are as follows: (1) to enhance solubility/dissolution/ bioavailability of poorly soluble drugs; (2) to enhance drug stability; (3) to modify the drug release site and/or time profile; and (4) to reduce drug side effects (for example, gastric or ocular irritation). These compounds present favorable toxicological profile for human use and therefore there are various medicines containing CDs approved by regulatory authorities worldwide. On the other hand, the major drawback of CDs is the increase in formulation bulk, once the CE is, in general, very low. This aspect is particularly relevant in solid dosage forms and limits the use of CDs to potent drugs. CDs have great potential as drug carriers in Pharmaceutical Technology and can be used by the formulator in order to improve the drug properties such as solubility, bioavailability and stability. Additionally, recent studies have shown that these compounds can be applied as active pharmaceutical ingredients. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing.

    Science.gov (United States)

    Hertrampf, A; Müller, H; Menezes, J C; Herdling, T

    2015-10-10

    Pharmaceutical excipients have an influence on the main requirements for medicinal products (viz., quality, safety and efficacy) but also on their manufacturability. During product lifecycle it may become necessary to introduce minor changes (e.g., to continuously improve it) or major changes in the validated process (e.g., moving it to a new production site, replacing process version or even disruptively changing processing type). Those changes can influence the critical to quality attributes of the product. Therefore, it is important to enhance process understanding to avoid the risk of any significant quality changes. Process analytical technology can support better decision making and risk-management as required in quality by design - viz., by many pharmaceutical regulatory authorities. This study compares the quality of the pharmaceutical excipient sodium carbonate (anhydrous) produced either in a batch or a continuous process. For continuous processing two different production lines were available that differed on the dryer and crystallizer types used. Therefore their influence on critical to quality attributes of sodium carbonate was investigated for each of the three processing alternatives. The overall goal was to identify which of the continuous processes ensures a similar product quality to batch processing. Namely, changes on chemical and physical attributes of the product were investigated with Raman spectroscopy, laser diffraction and X-ray powder diffraction. Principal component analysis, a very common multivariate analysis technique, was applied to extract relevant information from small differences at multiple spectral regions from samples from each process type and from each analytical technique used. Changing processing from batch to continuous improved consistency of certain attributes (e.g., particle size distribution) but affected others. However, the increased process/product knowledge gained can lead to an enhanced control strategy and

  11. [Hospital pharmaceutical practice in prison].

    Science.gov (United States)

    Harcouët, L

    2010-09-01

    Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  12. Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation.

    Directory of Open Access Journals (Sweden)

    Anna V Zetterqvist

    Full Text Available BACKGROUND: The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. METHODOLOGY: We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994-2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1 extent of violative advertising; (2 pattern of code breaches; (3 rate at which the system reacted to violative advertising; (4 prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5 costs for manufactures associated with violative advertising. PRINCIPAL FINDINGS: Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34% advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. CONCLUSIONS: Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system's failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across

  13. Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation.

    Science.gov (United States)

    Zetterqvist, Anna V; Mulinari, Shai

    2013-01-01

    The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994-2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system's failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory settings, and if appropriate measures are not taken to

  14. Misleading Advertising for Antidepressants in Sweden: A Failure of Pharmaceutical Industry Self-Regulation

    Science.gov (United States)

    Zetterqvist, Anna V.; Mulinari, Shai

    2013-01-01

    Background The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. Methodology We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994–2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Principal Findings Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Conclusions Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system’s failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory

  15. 76 FR 14943 - Antidisruptive Practices Authority

    Science.gov (United States)

    2011-03-18

    .... Higgins, Counsel to the Director of Enforcement, 202-418- 5864, [email protected] , Commodity Futures... Prohibit Disruptive Trading a. Panelists: Tom Gira--Financial Industry Regulatory Authority; Chris Heymeyer.... Panelists: Tom Gira--Financial Industry Regulatory Authority; Chris Heymeyer--National Futures Association...

  16. INAA of polyacrylic hydrogels of pharmaceutical grade

    International Nuclear Information System (INIS)

    Ponta, C.; Salagean, M.; Pantelica, A.; Georgescu, I.I.

    1998-01-01

    , higher values were found for Cr, (8.6±0.1) ppm, and Co, (149±6) ppb. Moreover, Br, As and Sb are present at the following levels: tens of ppb (Br), hundreds of ppb (As, Sb). In conclusion, in the procedure to obtain the polyacrylic acid hydrogels of pharmaceutical grade the raw components can be used with no additional purification, the elements like Zn, Fe, Cr in the final product being at the admissible level. Also, the most suitable milling procedure was chosen to be the ICPR mill. (authors)

  17. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

    The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

  18. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    2005-01-01

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

  19. PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

    Science.gov (United States)

    Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

    2016-01-01

    Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

  20. Author Details

    African Journals Online (AJOL)

    Visemih, Willium Muffee. Vol 9, No 2 (2001) - Articles The Role Of Internal Control In The Rural Development Of Cameroon: The Case Of The South West Development Authority (Soweda) Abstract. ISSN: 0856-6372. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's ...

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    African Journals Online (AJOL)

    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Abstract PDF · Vol 3, No 6 (2011) - Articles Mixed convection flow and heat transfer in a vertical wavy channel containing porous and fluid layer with traveling thermal waves. Abstract PDF · Vol 3, No 8 ...

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Singh, J. Vol 3, No 2 (2011) - Articles Plane waves in a rotating generalized thermo-elastic solid with voids. Abstract PDF. ISSN: 2141-2839. AJOL African Journals Online. HOW TO USE AJOL.

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Vol 12 (2008) - Articles On the wave equations of shallow water with rough bottom topography. Abstract · Vol 14 (2009) - Articles Energy generation in a plant due to variable sunlight intensity

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Ismail, A. Vol 9, No 3S (2017): Special Issue - Articles Investigate of wave absorption performance for oil palm frond and empty fruit bunch at 5.8 GHz. Abstract PDF · Vol 9, No 3S (2017): Special Issue ...

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Isa, M.F.M.. Vol 9, No 3S (2017): Special Issue - Articles Experimental and numerical investigation on blast wave propagation in soil structure. Abstract PDF · Vol 9, No 3S (2017): Special Issue - ...

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... No 3S (2017): Special Issue - Articles Experimental and numerical investigation on blast wave propagation in soil structure. Abstract PDF · Vol 9, No 3S (2017): Special Issue - Articles Simulation on ...

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    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... The use of negative pressure wave treatment in athlete recovery. Abstract PDF · Vol 29, No 1 (2017) - Articles The prevalence, risk factors predicting injury and the severity of injuries sustained during ...

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  13. The accumulation and management of pharmaceutical waste in the community pharmacy

    OpenAIRE

    Latožienė, Rima

    2017-01-01

    The Accumulation and Management of Pharmaceutical Waste in the Community Pharmacy Authors: students Diana Patašienė and Rima Latožienė, pharmacy master program at Vilnius University Faculty of Medicine, Department of Pathology, Forensic Medicine and Pharmacology. Work Leader: Dr. Kristina Garuolienė. The aim of the study: to determine pharmaceutical waste formation causes and to assess pharmaceutical waste management problems at community pharmacies. Materials and methods: The study was condu...

  14. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  15. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  16. Biricodar. Vertex Pharmaceuticals.

    Science.gov (United States)

    Dey, Saibal

    2002-05-01

    Vertex is developing biricodar as a chemosensitizing agent designed to restore the effectiveness of chemotherapeutic agents in tumor multidrug resistance. By November 1998, phase II trials had commenced for biricodar, in combination with chemotherapy, for five common cancer indications: breast, ovarian, soft-tissue sarcomas, small cell lung cancer and prostate cancer. Phase II trials were ongoing in January 2002. By March 2000, Vertex was the sole developer of biricodar, as an agreement made in 1996 with BioChem Pharma (now Shire Pharmaceuticals), for the development and marketing of biricodar in Canada was terminated. Biricodar is the free base compound, which also has a citrate salt analog known as VX-710-3. Vertex has published three patents, WO-09615101, WO-09636630 and WO-09736869, disclosing derivatives of biricodar that are claimed for the treatment of multidrug resistant protein and P-glycoprotein-mediated multidrug resistant tumors. In January 2002, a Banc of America analyst report forecast that biricodar had a 30% chance of reaching the market with a launch date in the second half of 2005, with peak sales estimated at $250 million.

  17. Pharmaceutical applications of graphene

    Directory of Open Access Journals (Sweden)

    Justyna Żwawiak

    2017-02-01

    Full Text Available Nowadays, dynamic development in nanotechnological sciences is observed. Nanoparticles are frequently used in medicine and pharmacy as delivery systems for different kinds of active substances. One of the latest developed substances, with an unusually wide scope of utility, is graphene. The ways of its use in different fields of industry, not only pharmaceutical and medical, have been a subject of study for many research groups since the moment of its development in 2004. Graphene in pure form is highly hydrophobic. However, the presence of defects on its surface allows chemical modifications to be made, e.g. introduction of oxygen groups by covalent bonding. Also, non-covalent modifications are extensively used, including van der Waals forces, hydrogen bonding, coordination bonds, electrostatic and π-π stacking interactions. Due to the large surface area, graphene can be used in combination therapy, consisting in simultaneous administration of two or more pharmacologically active agents. Another interesting approach is gene therapy. Application of the PEI-graphene oxide system increased the efficacy of transfection. Possibilities of graphene and graphene oxide are not limited to their use as active substance delivery systems. These compounds by themselves were also found to be bacteriostatic and antibacterial agents.

  18. Authoring Tools

    Science.gov (United States)

    Treviranus, Jutta

    Authoring tools that are accessible and that enable authors to produce accessible Web content play a critical role in web accessibility. Widespread use of authoring tools that comply to the W3C Authoring Tool Accessibility Guidelines (ATAG) would ensure that even authors who are neither knowledgeable about nor particularly motivated to produce accessible content do so by default. The principles and techniques of ATAG are discussed. Some examples of accessible authoring tools are described including authoring tool content management components such as TinyMCE. Considerations for creating an accessible collaborative environment are also covered. As part of providing accessible content, the debate between system-based personal optimization and one universally accessible site configuration is presented. The issues and potential solutions to address the accessibility crisis presented by the advent of rich internet applications are outlined. This challenge must be met to ensure that a large segment of the population is able to participate in the move toward the web as a two-way communication mechanism.

  19. Authorization of appropriations for the US Nuclear Regulatory Commission for fiscal years 1982 and 1983 (implementation of Section 110, Public Law 96-295). Oversight hearing before the Subcommittee on Energy and the Environment of the Committee on Interior and Insular Affairs, House of Representatives, Ninety-Seventh Congress, First Session, February 27, 1981. Part II

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    Part II of the budget authorization hearings covers the testimony of two panels, one with representatives of the Nuclear Regulatory Commission (NRC) and one with members of the Union of Concerned Scientists (UCS). Their testimony focused on section 10 of the authorization law which deals with requirements of systematic safety evaluation of operating reactors. NRC revisions to section 10 have quieted some industry criticisms that the plan will drain manpower and resources without accomplishing anything significant. UCS panelists challenged the NRC to provide objective scientific evidence that nuclear power plants are operating safely. They urged an augmented budget for further safety research. An appendix with additional statements and material follows the testimony

  20. Pharmaceutical care as a historical, normative-legal and social-economic category in the system of the population health and pharmaceutical care

    Directory of Open Access Journals (Sweden)

    G. L. Panfilova

    2014-08-01

    Full Text Available Aim. Terminological vagueness of the term «pharmaceutical care» in domestic legislative framework and scientific environment makes it impossible to introduce new forms and methods of providing pharmaceutical population in Ukraine effectively. In order to form the unified methodological approach to identify and order the use of the mentioned term, the results of organizational-economic studies in pharmacy and the existing legal framework have been analyzed. Methods and results. Using dialectical, historical, logical-semantic and other methods the basic stages in the development of pharmaceutical care have been established and definitions tree of the concept have been constructed. Conclusion. The results of these studies indicate the need for recognition and regulatory mapping integration (organizational and economic of the definition «pharmaceutical care» in domestic legislation and public health practice.

  1. Novel methodology for pharmaceutical expenditure forecast.

    Science.gov (United States)

    Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time

  2. Recognizing misleading pharmaceutical marketing online.

    Science.gov (United States)

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

  3. Marketing orientation in pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Prošić Danica

    2006-01-01

    Full Text Available Pharmaceutical companies are major stakeholders in the global health agenda Virtually all drugs used by patients in Europe reach markets through the promotion tactics of a small number of corporations with a tremendous impact on global health. The sector is both fast growing and highly profitable. Effective marketing strategies are a crucial ingredient in making sure pharmaceutical products and profits flow in a virtuous cycle. At first glance, the relationship between doctors and drug companies, as well as advertising practices for over-the-counter medication, appears tightly regulated. According to many consumer organizations, drug promotion in Europe today can be characterized as nice and friendly marketing. This refers to the creation of a false sense of trust that consumers associate with branded pharmaceutical products, as a result of pharmaceutical marketing efforts disguised as genuine corporate responsibility.

  4. in Leafy Vegetable and Pharmaceutical

    African Journals Online (AJOL)

    Bheema

    successfully employed for the determination of copper (II) in leafy vegetable and pharmaceutical samples. ... Our previous studies of transition metal ions such as zinc, cobalt and ..... A new method for extractive photometric determination of.

  5. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 12, No 6 (2013) >. Log in or Register to get access to full text downloads.

  6. Salvia officinalis used in pharmaceutics

    Science.gov (United States)

    Lemle, K. L.

    2018-01-01

    The paper presents some pharmaceutical properties of Salvia officinalis, a plant belonging the Lamiaceae family, one of the oldest medicinal plants, which play an important role in improving the state of health.

  7. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    We seek to encourage pharmaceutical and allied research of tropical and ... and related disciplines (including biotechnology, cell and molecular biology, drug ... with ibrutinib reduces proliferation, migration and invasion of lung cancer cells ...

  8. PARTICULARITIES OF MODERN PHARMACEUTICAL PROMOTION

    Directory of Open Access Journals (Sweden)

    Юрий Владимирович Тарасов

    2014-02-01

    Full Text Available Pharmaceutical products market is one of the most saturated consumers’ markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1

  9. Author Details

    African Journals Online (AJOL)

    Seeking Behavior Towards Dysmenorrhea among Female Students of a Private University in Ogun State, Nigeria Abstract PDF. ISSN: 2320-2041. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

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    Journal Home > Advanced Search > Author Details. Log in or Register ... (2013) - Articles Technical Note: Development of a Photobioreactor for Microalgae Culture ... Design, Construction and Evaluation of Motorized Okra Slicer Abstract PDF ...

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    Monitoring on Attitudes toward Internet Fraud among Undergraduate Students of Obafemi Awolowo University, Ile-Ife Abstract PDF. ISSN: 2070-0083. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

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    , Incubators and the Effects of a Spray-Disinfectant - A Quarterly Ammonium Compound Abstract. ISSN: 1116-1043. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL ...

  13. Author Details

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    676X. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions of Use · Contact AJOL · News. OTHER RESOURCES.

  14. Author Details

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    , happiness, hope and marital satisfaction among married people in Makurdi Metropolis, Nigeria Abstract. ISSN: 1596-9231. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about ...

  15. Author Details

    African Journals Online (AJOL)

    communication-style and parental neglect as predictors of aggressive tendencies among Secondary School adolescents. Abstract. ISSN: 0189-0263. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

  16. Author Details

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    Journal Home > Advanced Search > Author Details. Log in or Register to ... No 1 (2014) - Articles Knowledge and Attitudes towards Basic Cardiopulmonary Resuscitation (CPR) among Community Nurses in Remo Area of Ogun State, Nigeria

  17. Author Details

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    Mental State Examination and the Montreal Cognitive Assessment Test in schizophrenia. Abstract PDF. ISSN: 2078-6786. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about ...

  18. Author Details

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    ” Passages in the Context of Homosexuality Controversy: A Nigerian Perspective Abstract PDF. ISSN: 2141-7040. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL ...

  19. Author Details

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    plant interactions and arthropod trophic structure in an endangered grassland in the Free State province, South Africa Abstract. ISSN: 1022-0119. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

  20. Author Details

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    Journal Home > Advanced Search > Author Details. Log in or Register to get ... Optical bus of centralized relay protection and automation system of medium voltage switchgear for data collection and transmission. Abstract PDF. ISSN: 1112- ...

  1. Author Details

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    Journal Home > Advanced Search > Author Details. Log in or ... The prevention of mother-to-child HIV transmission programme and infant feeding practices ... Evaluation of a diagnostic algorithm for smear-negative pulmonary tuberculosis in ...

  2. Author Details

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    Journal Home > Advanced Search > Author Details ... Design and Implementation of an M/M/1 Queuing Model Algorithm and its Applicability in ... Vehicle Identification Technology to Intercept Small Arms and Ammunition on Nigeria Roads

  3. Author Details

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    509X. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions of Use · Contact AJOL · News. OTHER RESOURCES.

  4. Use of atypical antipsychotics in nursing homes and pharmaceutical marketing.

    Science.gov (United States)

    Pimentel, Camilla B; Donovan, Jennifer L; Field, Terry S; Gurwitz, Jerry H; Harrold, Leslie R; Kanaan, Abir O; Lemay, Celeste A; Mazor, Kathleen M; Tjia, Jennifer; Briesacher, Becky A

    2015-02-01

    To describe the current extent and type of pharmaceutical marketing in nursing homes (NHs) in one state and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs. Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial. Forty-one NHs in Connecticut. NH administrators, directors of nursing, and medical directors (n = 93, response rate 75.6%). Quantitative data, including prescription drug dispensing data (September 2009-August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing, and NH quality. Qualitative data, including semistructured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing. Leadership at 46.3% of NHs (n = 19) reported pharmaceutical marketing encounters, consisting of educational training, written and Internet-based materials, and sponsored training. No association was detected between level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader. NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  5. Nuclear magnetic resonance imaging in pharmaceutical research

    International Nuclear Information System (INIS)

    Sarkar, S.K.

    1991-01-01

    Nuclear magnetic resonance imaging has important applications in pharmaceutical research since it allows specific tissue and disease characterization in animal models noninvasively with excellent anatomical resolution and therefore provides improved ability to monitor the efficacy of novel drugs. The utility of NMR imaging in renal studies to monitor the mechanism of drug action and renal function in rats is described. The extension of the resolution of an NMR image to microscopic domain at higher magnetic field strengths and the utility of NMR microimaging in cerebrovascular and tumour metastasis studies in mice are discussed. (author). 40 refs., 14 figs

  6. Pharmaceutical compounds in drinking water

    Directory of Open Access Journals (Sweden)

    Vikas Chander

    2016-06-01

    Full Text Available Pharmaceutical products and their wastes play a major role in the degradation of environment. These drugs have positive as well as negative consequences on different environmental components including biota in different ways. Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, subsurface water, ground water, domestic waste water, municipal waste water and industrial effluents. The central as well as state governments in India are providing supports by creating excise duty free zones to promote the pharmaceutical manufacturers for their production. As a result, pharmaceutical companies are producing different types of pharmaceutical products at large scale and also producing complex non-biodegradable toxic wastes byproducts and releasing untreated or partially treated wastes in the environment in absence of strong regulations. These waste pollutants are contaminating all types of drinking water sources. The present paper focuses on water quality pollution by pharmaceutical pollutants, their occurrences, nature, metabolites and their fate in the environment.

  7. Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

    Science.gov (United States)

    de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

    2018-01-01

    Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

  8. Radiopharmaceuticals using radioactive compounds in pharmaceutics and medicine

    International Nuclear Information System (INIS)

    Theobald, A.

    1989-01-01

    This review of the latest techniques and developments indicates the importance of radiopharmaceutical techniques in the development of drug compounds. It presents practical demonstrations, offers practical exercises, as well as the underlying theoretical considerations: it will supplement existing (mostly American) texts in this subject, since most industrial pharmaceutical companies have a keen interest in the area and most pharmaceutical courses include the subject at degree level. The authors emphasize the pharmaceutical applications throughout. They review targeting aspects, including cell and protein labelling: and discuss radiotracers in testing dosage forms and formulation studies. Safety and legislation are considered, with reviews of the handling techniques, radiation monitoring, radiochromatography and the use of computer techniques. The latter part of the work discusses standards for radiopharmaceuticals, sterility and pyrogen testing, as well as both radiochromatographic and electrophoretic methods and their importance to quality control. (author)

  9. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.

    Science.gov (United States)

    Light, Donald W; Lexchin, Joel; Darrow, Jonathan J

    2013-01-01

    Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. © 2013 American Society of Law, Medicine & Ethics, Inc.

  10. Pharmaceutical market access in emerging markets: concepts, components, and future.

    Science.gov (United States)

    Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

  11. Authors' Response:

    Directory of Open Access Journals (Sweden)

    E Auger

    2012-03-01

    Full Text Available In this article, the authors suggest that one method for increasing awareness of the benefits of data sharing can be affected by administering a survey, hopefully encouraging either a minority or majority influence on other members of the behavioural science community. The authors describe the process for creating such a survey and provide their survey, although untested. This is a well-timed article as the existing literature on social and behavioural science data is quite thin. The majority/minority influence of norms is a nice theoretical construct to explore. This is definitely one approach to increase awareness of the benefits of data sharing.

  12. Psychiatric Resident and Faculty Views on and Interactions with the Pharmaceutical Industry

    Science.gov (United States)

    Misra, Sahana; Ganzini, Linda; Keepers, George

    2010-01-01

    Objective: Sales visits, or detailing, by pharmaceutical industry representatives at academic institutions has been increasingly criticized. The authors surveyed psychiatric residents and faculty members on their views and interactions with representatives of the pharmaceutical industry. Methods: In 2007, a 46-item online survey measuring…

  13. Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization.

    Science.gov (United States)

    Vredenbregt, M J; Caspers, P W J; Hoogerbrugge, R; Barends, D M

    2003-11-01

    Recently the CPMP/CVMP sent out for consultation the draft Note for Guidance (dNfG) on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization. We explored the practicability of this dNfG with respect to the verification of the correct identity of starting materials in a generic tablet-manufacturing site. Within the boundaries of the dNfG, a release procedure was developed for 12 substances containing structurally related compounds and substances differing only in particle size. For the method development literature data were also taken into consideration. Good results were obtained with wavelength correlation (WC), applied on raw spectra or second derivative spectra both without smoothing. The defined threshold of 0.98 for raw spectra differentiated between all molecular structures. Both methods were found to be robust over a period of 1 year. For the differentiation between the different particle sizes a subsequent second chemometric technique had to be used. Soft independent modelling of class analogy (SIMCA) with a probability level of 0.01 proved suitable. Internal and external validation I according to the dNfG showed no incorrect rejections or false acceptances. External validation II according to the dNfG was carried out with 95 potentially interfering substances from which 46 were tested experimentally. Macrogol 400 was not distinguished from macrogol 300. For the complete verification of the identity of macrogol 300 test A of the European Pharmacopoeia is needed in addition to the NIRS application. A release procedure developed with WC applied on raw spectra and SIMCA as a second method, which is different from the preferred method of the dNfG, was tested in practice with good results. We conclude that the dNfG has good practicability and that deviations from the preferred methods of the dNfG can also give good differentiation.

  14. Impact of pharmaceutical cocrystals: the effects on drug pharmacokinetics.

    Science.gov (United States)

    Shan, Ning; Perry, Miranda L; Weyna, David R; Zaworotko, Michael J

    2014-09-01

    Pharmaceutical cocrystallization has emerged in the past decade as a new strategy to enhance the clinical performance of orally administered drugs. A pharmaceutical cocrystal is a multi-component crystalline material in which the active pharmaceutical ingredient is in a stoichiometric ratio with a second compound that is generally a solid under ambient conditions. The resulting cocrystal exhibits different solid-state thermodynamics, leading to changes in physicochemical properties that offer the potential to significantly modify drug pharmacokinetics. The impact of cocrystallization upon drug pharmacokinetics has not yet been well delineated. Herein, we compile previously published data to address two salient questions: what effect does cocrystallization impart upon physicochemical properties of a drug substance and to what degree can those effects impact its pharmacokinetics. Cocrystals can impact various aspects of drug pharmacokinetics, including, but not limited to, drug absorption. The diversity of solid forms offered through cocrystallization can facilitate drastic changes in solubility and pharmacokinetics. Therefore, it is unsurprising that cocrystal screening is now a routine step in early-stage drug development. With the increasing recognition of pharmaceutical cocrystals from clinical, regulatory and legal perspectives, the systematic commercialization of cocrystal containing drug products is just a matter of time.

  15. Cell-Based Veterinary Pharmaceuticals - Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union.

    Science.gov (United States)

    Faltus, Timo; Brehm, Walter

    2016-01-01

    Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.

  16. Cell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union

    Science.gov (United States)

    Faltus, Timo; Brehm, Walter

    2016-01-01

    Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965

  17. Transformation in the pharmaceutical industry--a systematic review of the literature.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J; Mouzughi, Yusra

    2013-01-01

    The evolutionary development of pharmaceutical transformation was studied through systematic review of the literature. Fourteen triggers were identified that will affect the pharmaceutical business, regulatory science, and enabling technologies in future years. The relative importance ranking of the transformation triggers was computed based on their prevalence within the articles studied. The four main triggers with the strongest literature evidence were Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing. The theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities (this is termed pharmaceutical transformation). The impact of these changes on the approaches to quality risk management requires more understanding. In this paper, a comprehensive review of the academic, regulatory, and industry literature were used to identify 14 triggers that influence pharmaceutical transformation. The four main triggers, namely Fully Integrated Pharma Network, Personalized Medicine, Translational Research, and Pervasive Computing, were selected as the most important based on the strength of the evidence found during the literature review activity described in this paper. Theoretical quality risks for each of the four main transformation triggers are examined, and the remaining ten triggers are described.

  18. Author Details

    African Journals Online (AJOL)

    Manga, A.A.. Vol 10, No 1 (2017) - Articles Effect of different concentrations of aqueous Ascophyllum nodosum extract on flowering and fruiting in some vegetables. Abstract PDF. ISSN: 2006-6996. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL ...

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    African Journals Online (AJOL)

    Manga, Anicet. Vol 11, No 5 (2017) - Articles Le champignon arbusculaire Glomus aggregatum améliore la nutrition minérale de Acacia seyal soumis au stress salin progressif. Abstract PDF. ISSN: 1997-342X. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More ...

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    African Journals Online (AJOL)

    Manga, SB. Vol 29, No 2 (2008) - Articles Larvicidal efficacy of stock Bacillus sphaericus on local species of Anopheles mosquito in Sokoto, Nigeria Abstract. ISSN: 1117-4145. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners ...