WorldWideScience

Sample records for drug regulatory authorities

  1. 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.

  2. 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.

  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. 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

  5. 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)

  6. 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)

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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...

  12. 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

  13. 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

  14. 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.

  15. 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)

  16. 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...

  17. 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

  18. Orphan drugs: the regulatory environment.

    Science.gov (United States)

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. 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

  20. 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).

  1. 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

  2. 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

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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)

  11. The Dutch drug policy from a regulatory perspective

    NARCIS (Netherlands)

    Spapens, A.C.M.; Müller, T.; Van de Bunt, H.G.

    2015-01-01

    Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana (“soft drugs”) and other drugs (“hard drugs”). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow

  12. 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...

  13. 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...

  14. 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)

  15. 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...

  16. 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.

  17. 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.

  18. 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.

  19. 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)

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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)

  11. Regulatory and Economic Considerations of Retinal Drugs.

    Science.gov (United States)

    Shah, Ankoor R; Williams, George A

    2016-01-01

    The advent of anti-VEGF therapy for neovascular age-related macular degeneration and macular edema secondary to retinal vein occlusion and diabetes mellitus has prevented blindness in tens of thousands of people. However, the costs of these drugs are without precedent in ophthalmic drug therapeutics. An analysis of the financial implications of retinal drugs and the impact of the Food and Drug Administration on treatment of retinal disease must include not only an evaluation of the direct costs of the drugs and the costs associated with their administration, but also the cost savings which accrue from their clinical benefit. This chapter will discuss the financial and regulatory issues associated with retinal drugs. © 2016 S. Karger AG, Basel.

  12. 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...

  13. 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...

  14. 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

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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)

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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

  11. 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

  12. 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)

  13. 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.

  14. 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.

  15. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

  16. 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

  17. 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

  18. 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

  19. 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...

  20. 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

  1. 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

  2. Drug shortages in Israel: regulatory perspectives, challenges and solutions.

    Science.gov (United States)

    Schwartzberg, Eyal; Ainbinder, Denize; Vishkauzan, Alla; Gamzu, Ronni

    2017-01-01

    and temporary drug shortages are being implemented in Israel, such as suspending any further reductions in drug prices below 17 new Israeli shekels, instructing all MAHs to maintain no less than 1 month supply of all registered and non-registered drugs in Israel and allowing an expedited registration pathway for well-established use/grandfather drugs. Drug shortages pose significant public health hazards worldwide. Early notification to the MoH and open dialog with MAHs are essential for managing DSs and mitigating their impact. Despite the efforts carried out by health regulatory authorities worldwide, DSs still pose a significant threat to public health.

  3. 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

  4. 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

  5. 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

  6. 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)

  7. Challenges in orphan drug development and regulatory policy in China.

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  8. 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

  9. 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)

  10. A regulatory science viewpoint on botanical–drug interactions

    Directory of Open Access Journals (Sweden)

    Manuela Grimstein

    2018-04-01

    Full Text Available There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack of knowledge of the interaction potential poses a challenge for providers and both efficacy and safety concerns for patients. Botanical–drug combinations can produce untoward effects when botanical constituents modulate drug metabolizing enzymes and/or transporters impacting the systemic or tissue exposure of concomitant drugs. Examples of pertinent scientific literature evaluating the interaction potential of commonly used botanicals in the US are discussed. Current methodologies that can be applied to advance our efforts in predicting drug interaction liability is presented. This review also highlights the regulatory science viewpoint on botanical–drug interactions and labeling implications. Keywords: Drug interaction, Botanical product, St. John's wort, Fruit juices, Regulatory science

  11. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

    The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

  12. 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)

  13. 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...

  14. 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...

  15. 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...

  16. Improving clinical drug development regulatory procedures for anticonvulsants

    Directory of Open Access Journals (Sweden)

    Janković Slobodan

    2015-01-01

    Full Text Available Background: Clinical development of antiepileptic drugs is demanding due to complex character of the disorder and to diversity of its forms and etiologies. Objective: The aim of this review was to suggest improvements in regulatory procedures for clinical development of antiepileptic drugs. Methods: The following databases of scientific articles were searched: MEDLINE, SCOPUS and SCINDEKS. In total 558 publications were retrieved. The types of articles selected were reviews, reports on clinical trials and letters to the Editor. Results: There are several changes of regulatory documents necessary for improving process of clinical development of antiepileptic drugs: preference of parallel groups design for add-on trials should be explicit; the noninferiority design for monotherapy clinical trials should be acceptable; restrictive formulations when trials of antiepileptic drugs in children are in question should be avoided; requirements in regard to the efficacy measures should be harmonized among the regulatory bodies; proactive attitude towards discovery of adverse events; and precise requirements for clinical trials specifically designed to prove anti-epileptogenic effects should be made clear. Conclusion: Current regulatory documents are incomplete in many aspects; an international effort to improve and harmonize guidelines for clinical development of antiepileptic drugs is necessary for improvement of this process.

  17. 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.

  18. Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

    Science.gov (United States)

    Benda, Norbert; Brandt, Andreas

    2018-01-01

    Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

  19. 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

  20. 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.

  1. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  2. Drug lag and key regulatory barriers in the emerging markets

    Directory of Open Access Journals (Sweden)

    Harriet Wileman

    2010-01-01

    This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD, Certificate of Pharmaceutical Product (CPP, Good Manufacturing Practice (GMP, pricing approval, document authentication and harmonisation.

  3. 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...

  4. 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...

  5. 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.

  6. A regulatory science viewpoint on botanical-drug interactions.

    Science.gov (United States)

    Grimstein, Manuela; Huang, Shiew-Mei

    2018-04-01

    There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack of knowledge of the interaction potential poses a challenge for providers and both efficacy and safety concerns for patients. Botanical-drug combinations can produce untoward effects when botanical constituents modulate drug metabolizing enzymes and/or transporters impacting the systemic or tissue exposure of concomitant drugs. Examples of pertinent scientific literature evaluating the interaction potential of commonly used botanicals in the US are discussed. Current methodologies that can be applied to advance our efforts in predicting drug interaction liability is presented. This review also highlights the regulatory science viewpoint on botanical-drug interactions and labeling implications. Copyright © 2018. Published by Elsevier B.V.

  7. 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)

  8. Recent Advances in Drug Development and Regulatory Science in China.

    Science.gov (United States)

    Chen, Jie; Zhao, Naiqing

    2018-01-01

    As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval processes, and to harmonize its regulatory science with international standards, the China Food and Drug Administration (CFDA) has initiated a series of major changes to its policies and regulations. This paper presents a snapshot of China's pharmaceutical market, and research and development status, and introduces technical guidelines pertaining to clinical trials and new drug applications. The recent wave of ground-breaking reforms in CFDA's regulatory science is discussed. Examples of clinical trials and new drug applications are provided throughout the discussion.

  9. Problems in the regulatory policy of the drug market

    Science.gov (United States)

    Miziara, Nathália Molleis; Coutinho, Diogo Rosenthal

    2015-01-01

    OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber. METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012. RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies. CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body. PMID:26083945

  10. 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

  11. 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.

  12. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

    Science.gov (United States)

    Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

    2017-11-01

    Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

  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. Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

    International Nuclear Information System (INIS)

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

    2010-01-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

  5. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.

    Science.gov (United States)

    Tsukamoto, Katusra; Carroll, Kelly A; Onishi, Taku; Matsumaru, Naoki; Brasseur, Daniel; Nakamura, Hidefumi

    2016-03-01

    A dearth in pediatric drug development often leaves pediatricians with no alternative but to prescribe unlicensed or off-label drugs with a resultant increased risk of adverse events. We present the current status of pediatric drug development and, based on our data analysis, clarify the problems in this area. Further action is proposed to improve the drug development that has pediatric therapeutic orphan status. We analyzed all Phase II/III and Phase III trials in ClinicalTrials.gov that only included pediatric participants (Performance index, an indicator of pediatric drug development, was calculated by dividing the annual number of pediatric clinical trials by million pediatric populations acquired from Census.gov. Effects of the 2 Japanese premiums introduced in 2010, for the enhancement of pediatric drug development, were analyzed by comparing mean performance index prepremiums (2006-2009) and postpremiums (2010-2014) among Japan, the European Union, and the United States. The European Union Clinical Trials Register and published reports from the European Medicines Agency were also surveyed to investigate the Paediatric Committee effect on pediatric clinical trials in the European Union. Mean difference of the performance index in prepremiums and postpremiums between Japan and the European Union were 0.296 (P 15% after 2008. Recruitment and ethical obstacles make conducting pediatric clinical trials challenging. An improved operational framework for conducting clinical trials should mirror the ever-improving regulatory framework that incentivizes investment in pediatric clinical trials. Technological approaches, enhancements in electronic medical record systems, and community approaches that actively incorporate input from physicians, researchers, and patients could offer a sustainable solution to recruitment of pediatric study participants. The key therefore is to improve pediatric pharmacotherapy collaboration among industry, government, academia, and

  6. 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...

  7. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    Science.gov (United States)

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  8. Evolving regulatory paradigm for proarrhythmic risk assessment for new drugs.

    Science.gov (United States)

    Vicente, Jose; Stockbridge, Norman; Strauss, David G

    Fourteen drugs were removed from the market worldwide because their potential to cause torsade de pointes (torsade), a potentially fatal ventricular arrhythmia. The observation that most drugs that cause torsade block the potassium channel encoded by the human ether-à-go-go related gene (hERG) and prolong the heart rate corrected QT interval (QTc) on the ECG, led to a focus on screening new drugs for their potential to block the hERG potassium channel and prolong QTc. This has been a successful strategy keeping torsadogenic drugs off the market, but has resulted in drugs being dropped from development, sometimes inappropriately. This is because not all drugs that block the hERG potassium channel and prolong QTc cause torsade, sometimes because they block other channels. The regulatory paradigm is evolving to improve proarrhythmic risk prediction. ECG studies can now use exposure-response modeling for assessing the effect of a drug on the QTc in small sample size first-in-human studies. Furthermore, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a new in vitro paradigm for cardiac safety evaluation of new drugs that provides a more accurate and comprehensive mechanistic-based assessment of proarrhythmic potential. Under CiPA, the prediction of proarrhythmic potential will come from in vitro ion channel assessments coupled with an in silico model of the human ventricular myocyte. The preclinical assessment will be checked with an assessment of human phase 1 ECG data to determine if there are unexpected ion channel effects in humans compared to preclinical ion channel data. While there is ongoing validation work, the heart rate corrected J-T peak interval is likely to be assessed under CiPA to detect inward current block in presence of hERG potassium channel block. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. 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...

  10. 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...

  11. 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.

  12. 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

  13. Willingness to pay for adverse drug event regulatory actions.

    Science.gov (United States)

    Bouvy, Jacoline; Weemers, Just; Schellekens, Huub; Koopmanschap, Marc

    2011-11-01

    Regulatory requirements for the pharmaceutical industry have become increasingly demanding with respect to the safety and effectiveness of drugs. The objective of this study was to determine the willingness to pay (WTP), of both the Dutch general public and dialysis patients, for regulatory requirements related to reducing the risk of pure red cell aplasia (PRCA) associated with epoetin alpha use. A survey was carried out in April 2009. The Dutch general public (n = 422) was approached through a survey sampling agency. Patients (n = 112) were included through several Dutch dialysis clinics because they are often treated with epoetin alpha and therefore were expected to have a higher WTP than the general public. The survey aimed to determine the WTP for reducing the risk of PRCA in epoetin alpha users from 4.5 to 0 per 10 000 patients per year, based on regulatory actions that have been taken by the European Medicines Agency (EMA). WTP was determined via a payment scale and an open-ended follow-up question. Patients were asked how much extra per year they would be willing to pay for their basic healthcare insurance. We used two censored regression models to test the association between WTP and a set of independent variables: a Tobit model with the stated WTP as the dependent variable and an interval regression model with the interval between the lower and upper bounds of the payment scale as the dependent variable. The patients' mean WTP was significantly higher (€46.52) than that of the general public (€24.40). The Tobit model showed significant associations (α = 0.05) with WTP for dialysis patients, risk perception and respondents' opinions on costs of healthcare. The interval regression model showed significant associations with WTP for the same variables as the Tobit model and for one additional variable (risk aversion). Income did not significantly affect WTP. A scenario with a 10-fold larger risk reduction did not increase WTP significantly

  14. 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.

  15. Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

    Science.gov (United States)

    Romero, Klaus; Clay, Robert; Hanna, Debra

    2015-08-15

    The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp). © The Author 2015. Published by Oxford University Press on behalf of the

  16. 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...

  17. 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...

  18. 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)

  19. 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)

  20. 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.)

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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)

  7. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  8. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  9. 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)

  10. 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

  11. 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)

  12. 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

  13. 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.

  14. 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.

  15. 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)

  16. 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

  17. 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

  18. 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.

  19. 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

  20. Information to Improve Public Perceptions of the Food and Drug Administration (FDA’s Tobacco Regulatory Role

    Directory of Open Access Journals (Sweden)

    Amira Osman

    2018-04-01

    Full Text Available While the Food and Drug Administration (FDA has had regulatory authority over tobacco products since 2009, public awareness of this authority remains limited. This research examines several broad types of information about FDA tobacco regulatory mission that may improve the perceptions of FDA as a tobacco regulator. Using Amazon Mechanical Turk, 1766 adults, smokers and non-smokers, were randomly assigned to view a statement about FDA regulatory authority that varied three information types in a 2 × 2 × 2 between subjects experimental design: (1 FDA’s roles in regulating tobacco (yes/no; (2 The scientific basis of regulations (yes/no; and (3 A potential protective function of regulations (yes/no. Using factorial ANOVA, we estimated the main and interactive effects of all three types of information and of smoking status on the perceptions of FDA. Participants that were exposed to information on FDA roles reported higher FDA credibility and a greater perceived knowledge of FDA than those who did not. Exposure to information about the scientific basis of regulations led to more negative views of the tobacco industry. Participants who learned of the FDA’s commitment to protecting the public reported higher FDA credibility and more positive attitudes toward regulations than those who did not learn of this commitment. We observed no significant interaction effects. The findings suggest that providing information about the regulatory roles and protective characterization of the FDA’s tobacco regulatory mission positively influence public perceptions of FDA and tobacco regulations.

  1. 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

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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.

  7. 42 CFR 2.1 - Statutory authority for confidentiality of drug abuse patient records.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Introduction § 2.1 Statutory authority for confidentiality of drug abuse patient records. The restrictions of these regulations upon the disclosure and use of drug abuse patient records were initially authorized by section 408...

  8. Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

    Science.gov (United States)

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

    Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

  9. 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

  10. Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.

    Science.gov (United States)

    Nakayama, Hiroki; Tsukamoto, Katsura

    2018-04-17

    The approval of orphan anticancer drugs has increased, with the number exceeding that of non-orphan drugs in Japan in recent years. Although orphan anticancer drugs may have unique characteristics due to their rarity, these have not been fully characterized. We investigated anticancer drugs approved in Japan between April 2004 and November 2017 to reveal the characteristics of regulatory approval and pivotal studies on orphan anticancer drugs compared to non-orphan drugs. The median regulatory review time and number of patients in pivotal studies on orphan anticancer drugs (281.0 days [interquartile range, 263.3-336.0]; 222.5 patients [66.0-454.3]) were significantly lower than those on non-orphan drugs (353.0 days [277.0-535.5]; 521.0 patients [303.5-814.5], respectively) (P < 0.001). Phase II, non-randomized and non-controlled designs were more frequently used in pivotal studies on orphan anticancer drugs (45.9%, 41.9% and 43.2%) than non-orphan drugs (17.2%, 14.1% and 14.1%, respectively). Response rate was more commonly used as a primary endpoint in pivotal studies on orphan anticancer drugs (48.6%) than non-orphan drugs (17.2%). Indications limited by molecular features, second or later treatment line, and accelerated approval in the United States were associated with the use of response rate in orphan anticancer drug studies. In conclusion, we demonstrated that orphan anticancer drugs in Japan have unique characteristics compared to non-orphan drugs: shorter regulatory review and pivotal studies frequently using phase II, non-randomized, or non-controlled designs and response rate as a primary endpoint, with fewer patients.

  11. 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.)

  12. 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)

  13. [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.

  14. The evaluation of drug regulation - economic approaches into the valuation and evaluation of the drug regulatory framework

    NARCIS (Netherlands)

    Bouvy, J.C.

    2013-01-01

    The European pharmaceutical market is strictly regulated. Sufficient levels of quality, safety, and efficacy will have to be demonstrated before a pharmaceutical is allowed to enter the market. There is little evidence, however, that the current drug regulatory framework is achieving its goals of

  15. 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)

  16. 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)

  17. 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

  18. 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

  19. Influence of Japanese Regulatory Action on Denosumab-Related Hypocalcemia Using Japanese Adverse Drug Event Report Database.

    Science.gov (United States)

    Takeyama, Mayu; Sai, Kimie; Imatoh, Takuya; Segawa, Katsunori; Hirasawa, Noriyasu; Saito, Yoshiro

    2017-01-01

    The anti-receptor activator of nuclear factor kappa-B ligand (RANKL) antibody, Denosumab (DEN), was approved in April 2012 in Japan, but a Dear Healthcare Professional Letter of Rapid Safety Communication was released in September, 2012 by the regulatory authority because of the severe hypocalcemia risks. Currently, the effectiveness of this regulatory action has not been evaluated and, therefore, this study aimed to assess its impact on DEN-induced hypocalcemia using the Japanese Adverse Drug Event Report database (JADER). The case reports from April 2012 to September 2014 were collected from the JADER, which included 151642 adverse events for the primary suspected drugs. The reporting odds ratio (ROR) of hypocalcemia as a signal of the target adverse event was analyzed for DEN and zoledronic acid (ZOL, a reference drug). Changes in RORs were compared between the pre- (Pre, April 2012 to September 2012) and post- (Post 1, October 2012 to September 2013 and Post 2, October 2013 to September 2014) periods of the regulatory action. A decrease in the hypocalcemia ROR was observed for DEN in the post-periods, especially Post 2. Multivariate logistic regression analysis showed a significant decrease in hypocalcemia signal in Post 1 (p=0.0306 vs. Pre) and Post 2 (p=0.0054 vs. Pre). ZOL caused no significant changes in ROR of hypocalcemia, and none of the drugs caused ROR changes in jaw osteonecrosis (a reference adverse event). This study suggests that the regulatory action against hypocalcemia in DEN effectively decreased hypocalcemia signal. Further studies using medical information databases are needed to confirm this result.

  20. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

    Science.gov (United States)

    Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

    2017-01-01

    The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

  1. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

    Directory of Open Access Journals (Sweden)

    J. Javier Hernandez

    2017-11-01

    Full Text Available The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

  2. 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.)

  3. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  4. 75 FR 70932 - Office of the Commissioner of Food and Drugs; Delegation of Authority

    Science.gov (United States)

    2010-11-19

    ... exercise of the authorities delegated herein prior to the effective date of this delegation. This... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Office of the Secretary... delegated to the Commissioner of Food and Drugs the authorities vested in the Secretary of Health and Human...

  5. Influence of drug molecules on regulatory B cells.

    Science.gov (United States)

    Amrouche, Kahina; Jamin, Christophe

    2017-11-01

    By their suppressive functions, regulatory B (Breg) cells are considered as key elements in the control and development of various disease states. Many signals can induce Bregs in vivo and in vitro and often from heterogeneous populations. Several specific signals delivered in a timely immunological context contribute to the establishment of Bregs. These are endogenous and physiological signals or stimuli, widely discussed in the literature participating in the establishment of an effective immune response. However, exogenous signals, much less clearly identified can also be considered as Bregs inducers. These extrinsic signals are capable of directly or indirectly influencing the suppressive capacity of Bregs, but also their expansion and functional restoration in its absence. Faced with the excitement generated by the development of processes favoring the expansion of Bregs in mice for therapeutic purposes, the challenge today is to extrapolate such approaches in humans. This perspective may already be in effect. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. 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

  7. 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

  8. Control authorities of internal affairs bodies in the sphere of drug trafficking

    Directory of Open Access Journals (Sweden)

    О. М. Шевчук

    2014-06-01

    Full Text Available The article deals with control authorities of internal Affairs bodies in the sphere of turnover of narcotic drugs, psychotropic substances and precursors. Established the concept of the legal status of the Management of the fight against illegal circulation of drugs of the Ministry of interior of Ukraine and describes its features. The classification of control authorities of internal Affairs bodies in the sphere of turnover of narcotic drugs, psychotropic substances and precursors and analyzed for their content.

  9. Antibody-drug conjugates for cancer therapy: The technological and regulatory challenges of developing drug-biologic hybrids.

    Science.gov (United States)

    Hamilton, Gregory S

    2015-09-01

    Antibody-drug conjugates (ADCs) are a new class of therapeutic agents that combine the targeting ability of monoclonal antibodies (mAbs) with small molecule drugs. The combination of a mAb targeting a cancer-specific antigen with a cytotoxin has tremendous promise as a new type of targeted cancer therapy. Two ADCs have been approved and many more are in clinical development, suggesting that this new class of drugs is coming to the forefront. Because of their unique nature as biologic-small drug hybrids, ADCs are challenging to develop, from both the scientific and regulatory perspectives. This review discusses both these aspects in current practice, and surveys the current state of the art of ADC drug development. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  10. 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

  11. 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)

  12. 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)

  13. 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.

  14. 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.)

  15. 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.

  16. 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)

  17. Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

    NARCIS (Netherlands)

    Kooijman, M.; Van Meer, P.J.K.; Moors, E.H.M.; Hekkert, M.P.; Schellekens, H.

    2011-01-01

    The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in

  18. A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.

    Science.gov (United States)

    Calderon, Silvia N; Klein, Michael

    2014-12-01

    In the United States of America (USA), the abuse potential assessment of a drug is performed as part of the safety evaluation of a drug under development, and to evaluate if the drug needs to be subject to controls that would minimize the abuse of the drug once on the market. The assessment of the abuse potential of new drugs consists of a scientific and medical evaluation of all data related to abuse of the drug. This paper describes the regulatory framework for evaluating the abuse potential of new drugs, in general, including novel stimulants. The role of the United States Food and Drug Administration (FDA) in the evaluation of the abuse potential of drugs, and its role in drug control are also discussed. A definition of abuse potential, an overview of the currently accepted approaches to evaluating the abuse potential of a drug, as well as a description of the criteria that applies when recommending a specific level of control (i.e., a Schedule) for a drug under the Controlled Substances Act (CSA). This article is part of the Special Issue entitled 'CNS Stimulants'. Published by Elsevier Ltd.

  19. 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.

  20. 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.).

  1. 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

  2. 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...

  3. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  4. 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.

  5. Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

    Science.gov (United States)

    Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

    2018-01-01

    Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for

  6. 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

  7. 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...

  8. 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

  9. 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

  10. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

    Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

  11. Regulatory scientific advice in drug development: does company size make a difference?

    Science.gov (United States)

    Putzeist, Michelle; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G

    2011-02-01

    To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006-2008. Definition of company size was based on ranking by total revenues (Scrip's Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P companies (P = 0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development.

  12. Genome-wide discovery of drug-dependent human liver regulatory elements.

    Directory of Open Access Journals (Sweden)

    Robin P Smith

    2014-10-01

    Full Text Available Inter-individual variation in gene regulatory elements is hypothesized to play a causative role in adverse drug reactions and reduced drug activity. However, relatively little is known about the location and function of drug-dependent elements. To uncover drug-associated elements in a genome-wide manner, we performed RNA-seq and ChIP-seq using antibodies against the pregnane X receptor (PXR and three active regulatory marks (p300, H3K4me1, H3K27ac on primary human hepatocytes treated with rifampin or vehicle control. Rifampin and PXR were chosen since they are part of the CYP3A4 pathway, which is known to account for the metabolism of more than 50% of all prescribed drugs. We selected 227 proximal promoters for genes with rifampin-dependent expression or nearby PXR/p300 occupancy sites and assayed their ability to induce luciferase in rifampin-treated HepG2 cells, finding only 10 (4.4% that exhibited drug-dependent activity. As this result suggested a role for distal enhancer modules, we searched more broadly to identify 1,297 genomic regions bearing a conditional PXR occupancy as well as all three active regulatory marks. These regions are enriched near genes that function in the metabolism of xenobiotics, specifically members of the cytochrome P450 family. We performed enhancer assays in rifampin-treated HepG2 cells for 42 of these sequences as well as 7 sequences that overlap linkage-disequilibrium blocks defined by lead SNPs from pharmacogenomic GWAS studies, revealing 15/42 and 4/7 to be functional enhancers, respectively. A common African haplotype in one of these enhancers in the GSTA locus was found to exhibit potential rifampin hypersensitivity. Combined, our results further suggest that enhancers are the predominant targets of rifampin-induced PXR activation, provide a genome-wide catalog of PXR targets and serve as a model for the identification of drug-responsive regulatory elements.

  13. 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.

  14. 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

  15. Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

    Science.gov (United States)

    Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

    2017-04-01

    Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

  16. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  17. 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

  18. 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

  19. 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.

  20. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.

    Science.gov (United States)

    Plank, Linda S

    2011-01-01

    The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority. © 2011 by the American College of Nurse-Midwives.

  1. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  2. Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science.

    Science.gov (United States)

    Leeder, J Steven; Kearns, Gregory L; Spielberg, Stephen P; van den Anker, John

    2010-12-01

    Understanding the dose-exposure-response relationship across the pediatric age spectrum from preterm and term newborns to infants, children, adolescents, and adults is a major challenge for clinicians, pharmaceutical companies, and regulatory agencies. Over the past 3 decades, clinical investigations of many drugs commonly used in pediatric therapeutics have provided valuable insights into age-associated differences in drug disposition and action. However, our understanding of the contribution of genetic variation to variability in drug disposition and response in children generally has lagged behind that of adults. This article proposes a systematic approach that can be used to assess the relative contributions of ontogeny and genetic variation for a given compound. Application of the strategy is illustrated using the current regulatory dilemma posed by the safety and effectiveness of over-the-counter cough and cold remedies as an example. The results of the analysis can be used to aid in the design of studies to yield maximally informative data in pediatric populations of different ages and developmental stages and thereby improve the efficiency of study design.

  3. Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

    Science.gov (United States)

    Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

    2018-02-01

    Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  4. Regulatory volume decrease in Leishmania mexicana: effect of anti-microtubule drugs

    Directory of Open Access Journals (Sweden)

    Francehuli Dagger

    2013-02-01

    Full Text Available The trypanosomatid cytoskeleton is responsible for the parasite's shape and it is modulated throughout the different stages of the parasite's life cycle. When parasites are exposed to media with reduced osmolarity, they initially swell, but subsequently undergo compensatory shrinking referred to as regulatory volume decrease (RVD. We studied the effects of anti-microtubule (Mt drugs on the proliferation of Leishmania mexicana promastigotes and their capacity to undergo RVD. All of the drugs tested exerted antiproliferative effects of varying magnitudes [ansamitocin P3 (AP3> trifluoperazine > taxol > rhizoxin > chlorpromazine]. No direct relationship was found between antiproliferative drug treatment and RVD. Similarly, Mt stability was not affected by drug treatment. Ansamitocin P3, which is effective at nanomolar concentrations, blocked amastigote-promastigote differentiation and was the only drug that impeded RVD, as measured by light dispersion. AP3 induced 2 kinetoplasts (Kt 1 nucleus cells that had numerous flagella-associated Kts throughout the cell. These results suggest that the dramatic morphological changes induced by AP3 alter the spatial organisation and directionality of the Mts that are necessary for the parasite's hypotonic stress-induced shape change, as well as its recovery.

  5. 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)

  6. Introduction of direct-to-consumer advertising of prescription drugs in Canada: an opinion survey on regulatory policy.

    Science.gov (United States)

    Mintzes, Barbara; Barer, Morris; Lexchin, Joel; Bassett, Ken L

    2005-06-01

    Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments. We recruited key informants on pharmaceutical policy to complete a faxed questionnaire that queried their opinions on DTCA information quality, effects on drug and health care use, and regulatory issues. Respondents were asked about the evidence they had used to back their opinions. Analysis was descriptive. Of 79 identified potential participants, 60 (76%) participated, 40% of whom were from federal and provincial government; 3% were private insurers; 18%, 15%, and 8% were from health professional groups, consumer groups, and patient groups, respectively; 8% and 7% were from pharmaceutical and advertising industries, respectively. Opinions were highly polarized on the effects of DTCA on drug and health care use. Advertising and pharmaceutical industry respondents were generally positive, public sector, health professional and consumer groups generally negative. Over 80% believed DTCA leads to higher private and public drug costs and more frequent physician visits. Fewer judged billboards or television to be appropriate media for DTCA than magazines or the Internet, and most believed that children and adolescents should not be targeted. Given the polarization observed within this survey, we examined how DTCA policy has evolved in Canada since 2001. The federal government has legislative authority over DTCA, but bears few of the additional costs potentially incurred through policy change. These fall to the provinces, which provide an eroding patchwork of public coverage for prescription drugs in the face of rapidly increasing costs. No new federal legislation has been tabled since 2001. However, considerable shifts in

  7. Regulatory aspects of teratology: role of the Food and Drug Administration

    International Nuclear Information System (INIS)

    Kelsey, F.O.

    1982-01-01

    The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products

  8. Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

    Science.gov (United States)

    Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

    2016-11-01

    This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

  9. Risk perception of prescription drugs: results of a survey among experts in the European regulatory network.

    Science.gov (United States)

    Beyer, Andrea R; Fasolo, Barbara; Phillips, Lawrence D; de Graeff, Pieter A; Hillege, Hans L

    2013-05-01

    Experts are perceived to be veridical and to focus only on objective data when evaluating risk. Only a few research studies have attempted to characterize the subjectivity in risk evaluation among experts. The hypothesis of this study is that expert evaluation of a pharmaceutical drug can be partly explained by dimensions that describe the drug and by individual characteristics. Seventy-five medical assessors in 9 EU countries evaluated a list of 28 pharmaceutical drugs using 4 scales: risk, benefit, seriousness of harm, and patients' knowledge of the risk. They were also given a mock "clinical dossier" and asked to rate it on 8 dimensions: risk, benefit, worry, magnitude of the exposure, scientific knowledge of the risk, familiarity of the risk, ethical concerns, and risk acceptability. Female assessors perceived significantly higher benefits than men for a large number of the 28 drugs. Principal component analysis of the ratings for the clinical dossiers revealed 2 underlying components: seriousness of harm and scientific evidence. A regression model predicting the risk perception of the drug showed that the variables seriousness of harm (benefit, worry, magnitude of exposure, ethical concerns, and risk acceptability), years of regulatory experience, gender, and type of drug explained 54% of the variability among assessors. Assessors' view of the risks associated with pharmaceutical drugs is influenced by worry for patient safety, magnitude of patient exposure, and ethical concerns. These dimensions may influence their perceptions of benefit and risk acceptability. Senior assessors are more risk averse than junior assessors, and female assessors seem to be sensitive to the promise of benefit from medicines and consequently may be less risk averse than male assessors.

  10. 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

  11. 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...

  12. 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)

  13. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  14. 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

  15. The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.

    Science.gov (United States)

    Hashan, Hajed; Aljuffali, Ibrahim; Patel, Prisha; Walker, Stuart

    This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration. All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval. To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.

  16. 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)

  17. 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.

  18. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  19. Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

    Science.gov (United States)

    Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

    2014-04-11

    Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  20. Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs.

    Science.gov (United States)

    Koh, H L; Woo, S O

    2000-11-01

    Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer's name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Random drug and alcohol testing of individuals who have... PROGRAMS Granting and Maintaining Authorization § 26.67 Random drug and alcohol testing of individuals who... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

  7. 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)

  8. Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years

    Directory of Open Access Journals (Sweden)

    Mariangela Prada

    Full Text Available Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP that are available on the Italian market (July 2016, and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month. Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD 108; range 266-770; the average approval time for AIFA was about 248 days (SD 131; range 85-688. Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.

  9. Regulatory Notes on Impact of Excipients on Drug Products and the Maillard Reaction.

    Science.gov (United States)

    Chowdhury, Dipak K; Sarker, Haripada; Schwartz, Paul

    2018-02-01

    In general, it is an important criterion that excipients remain inert throughout the shelf life of the formulated pharmaceutical product. However, depending on the functionality in chemical structure of active drug and excipients, they may undergo interaction. The well-known Maillard reaction occurs between a primary amine with lactose at high temperature to produce brown pigments. The reactivity of Maillard reaction may vary depending on the concentration as well as other conditions. Commercially, there are products where the active pharmaceutical ingredient is a primary amine and contains less than 75% lactose along with inactive excipients. This product does not show Maillard reaction during its shelf life of around 2 years at ambient conditions. However, when the same type of product contains more than 95 % lactose as an excipient, then there is a possibility of interactions though it is not visible in the initial year. Therefore, this regulatory note discusses involvement of different factors of a known drug-excipient interactions with case studies and provides an overview on how the concentration of lactose in the pharmaceutical product is important in addition to temperature and moisture in Maillard reaction.

  10. Drug policy and global regulatory capitalism: the case of new psychoactive substances (NPS).

    Science.gov (United States)

    Seddon, Toby

    2014-09-01

    The recent emergence of vibrant markets in 'new psychoactive substances' or 'legal highs' has posed significant new challenges for drug policy. These partly concern what to do about them but the speed and complexity of change has also raised difficulties for how policy responses should be developed. Existing drug policy systems appear too slow and cumbersome to keep up with the pace of change, remaining locked in large part within 'old' ways of thinking that centre almost exclusively around the deployment (or not) of the criminal law and its related enforcement apparatus. In this paper, it is argued that we need to rethink the problem through the lens of regulation, in order to learn lessons from other sectors where more agile responses to changing markets and business innovation have often proved possible. By examining examples drawn from these other areas, an alternative policy-making framework can be developed, involving a more flexible mix of state regulation, civil society action and private law mechanisms. This new approach is founded on a recognition of the networked and polycentric character of effective market governance in an era of global regulatory capitalism. Copyright © 2014 Elsevier B.V. All rights reserved.

  11. [Glucokinase and glucokinase regulatory proteins as molecular targets for novel antidiabetic drugs].

    Science.gov (United States)

    Rubtsov, P M; Igudin, E L; Tiulpakov, A N

    2015-01-01

    The impairment of glucose homeostasis leads to hyperglycemia and type-2 diabetes mellitus. Glucokinase (GK), an enzyme that catalyzes the conversion of glucose to glucose-6-phosphate in pancreatic ß-cells, liver hepatocytes, specific hypothalamic neurons, and intestine enterocytes, is a key regulator of glucose homeostasis. In hepatocytes, GK controls the glucose uptake and glycogen synthesis and inhibits the glucose synthesis via the gluconeogenesis pathway. Glucokinase regulatory protein (GKRP) synthesized in hepatocytes acts as an endogenous GK inhibitor. During fasting, GKRP binds GK, inactivates it, and transports it into the cell nucleus, thus isolating it from the hepatocyte carbohydrate metabolism. In the beginning of the 2000s, the research was mainly focused on the development and trials of the small molecule GK activators as potential antidiabetic glucose-lowering drugs. However, the use of such substances increased the risk of hypoglycemia, and clinical studies of most synthetic GK activators are currently discontinued. Allosteric inhibitors of the GK-GKRP interaction are coming as alternative agents increasing the GK activity that can substitute GKA. In this review, we discuss the recent advances and the current state of art in the development of potential antidiabetic drugs targeted to GK as a key regulator of glucose homeostasis.

  12. 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

  13. 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

  14. 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.

  15. 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

  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 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.

  17. 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.

  18. 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

  19. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  20. 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)

  1. A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators.

    Science.gov (United States)

    Ponzano, Stefano; Nigrelli, Giulia; Fregonese, Laura; Eichler, Irmgard; Bertozzi, Fabio; Bandiera, Tiziano; Galietta, Luis J V; Papaluca, Marisa

    2018-06-30

    In this article we analyse the current authorised treatments and trends in early drug development for cystic fibrosis (CF) in the European Union for the time period 2000-2016. The analysis indicates a significant improvement in the innovation and development of new potential medicines for CF, shifting from products that act on the symptoms of the disease towards new therapies targeting the cause of CF. However, within these new innovative medicines, results for CF transmembrane conductance regulator (CFTR) modulators indicate that one major challenge for turning a CF concept product into an actual medicine for the benefit of patients resides in the fact that, although pre-clinical models have shown good predictability for certain mutations, a good correlation to clinical end-points or biomarkers ( e.g. forced expiratory volume in 1 s and sweat chloride) for all mutations has not yet been achieved. In this respect, the use of alternative end-points and innovative nonclinical models could be helpful for the understanding of those translational discrepancies. Collaborative endeavours to promote further research and development in these areas as well as early dialogue with the regulatory bodies available at the European competent authorities are recommended. Copyright ©ERS 2018.

  2. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    Science.gov (United States)

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

  3. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Wafula Francis N

    2012-07-01

    Full Text Available Abstract Background Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. Methods We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. Results We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory

  4. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature.

    Science.gov (United States)

    Wafula, Francis N; Miriti, Eric M; Goodman, Catherine A

    2012-07-27

    Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory enforcement and practices of specialized drug shops

  5. Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

    Science.gov (United States)

    Pignatti, Francesco; Ehmann, Falk; Hemmings, Robert; Jonsson, Bertil; Nuebling, Micha; Papaluca-Amati, Marisa; Posch, Martin; Rasi, Guido

    2014-03-15

    The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

  6. Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

    Science.gov (United States)

    Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y

    2018-02-01

    The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

  7. 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

  8. 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)

  9. 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

  10. 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.

  11. 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

  12. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    Science.gov (United States)

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

  13. 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.)

  14. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Science.gov (United States)

    2013-05-09

    ... Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; request for public comments. The Food and Drug Administration (FDA or the Agency) is announcing a... of complex drug substances 13. Develop a risk-based understanding of potential adverse impacts to...

  15. 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

  16. 24 CFR 5.858 - What authority do I have to evict drug criminals?

    Science.gov (United States)

    2010-04-01

    ... Federally Assisted Housing-Denying Admission and Terminating Tenancy for Criminal Activity or Alcohol Abuse... use of a drug interferes with the health, safety, or right to peaceful enjoyment of the premises by...

  17. 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)

  18. 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

  19. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Science.gov (United States)

    2010-02-01

    ... other things, the CMEA amended the CSA to change the regulations for selling nonprescription products... redelegation will empower the Deputy Assistant Administrator, among other things, to exercise signing authority... Administration. The redelegation of signature authority for the regulations in part 1314 is consistent with the...

  20. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

    Science.gov (United States)

    Abraham, John; Davis, Courtney

    2005-09-01

    By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

  1. 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

  2. [Galenical possibilities and problems in protraction of drug effects (author's transl)].

    Science.gov (United States)

    Müller, F

    1976-01-01

    In recent years, dosage forms with sustained release have obtained a significant importance. The technological possibilities for manufacturing are described as coating, embedding and matrix procedures. The range of auxiliary substances, which are responsible for the retardation of drug activity, reaches from lipophilic compounds as lipoids, fatty alcohols and compounds which are forming hydrogels as cellulose derivatives and natural polysaccharides to synthetic polymers derived from acrylic acid. The formulation of the dosage forms requires particular care in respect to the amount of initial and maintenance doses. On account of technological processes, for example during manufacturing of tablets, under certain circumstances the liberation rate is altered. In vitro test methods allow comparisons only then when the results can be counter-checked by in vitro experiments. The release of drug follows different mechanisms, which are described, entirely or in part, to be reactions following the time law of zero or first order. In special cases, a linear correlation is observed as a function of square root of time. The calculation of given special equations for events within the dosage form is feasible from blood-level values.

  3. 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

  4. Author correction: Micromotor-enabled active drug delivery for in vivo treatment of stomach infection.

    Science.gov (United States)

    de Ávila, Berta Esteban-Fernández; Angsantikul, Pavimol; Li, Jinxing; Angel Lopez-Ramirez, Miguel; Ramírez-Herrera, Doris E; Thamphiwatana, Soracha; Chen, Chuanrui; Delezuk, Jorge; Samakapiruk, Richard; Ramez, Valentin; Obonyo, Marygorret; Zhang, Liangfang; Wang, Joseph

    2017-10-31

    Marygorret Obonyo, who provided the H. pylori SS1 strain for this work and participated in the design of H. pylori infection studies, was inadvertently omitted from the author list. This has now been corrected in both the PDF and HTML versions of the Article.

  5. 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

  6. Imprecise Frequency Descriptors and the Miscomprehension of Prescription Drug Advertising: Public Policy and Regulatory Implications.

    Science.gov (United States)

    Davis, Joel J.

    1999-01-01

    Explores the communicative effectiveness of imprecise frequency descriptors within the context of consumer prescription drug advertising. Conducts two separate studies using a total sample of 147 adults. Finds that consumers are unable to accurately estimate the relative likelihood of side effect occurrence when a list of side effects are preceded…

  7. 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.)

  8. Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.

    Science.gov (United States)

    Engelhardt, Jeffery A; Fant, Pierluigi; Guionaud, Silvia; Henry, Scott P; Leach, Michael W; Louden, Calvert; Scicchitano, Marshall S; Weaver, James L; Zabka, Tanja S; Frazier, Kendall S

    2015-10-01

    Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. In recent years, DIVI has been occasionally observed in nonhuman primates given RNA-targeting therapeutics such as antisense oligonucleotide therapies (ASOs) during chronic toxicity studies. While DIVI in laboratory animal species has been well characterized for vasoactive small molecules, and immune-mediated responses against large molecule biotherapeutics have been well described, there is little published information regarding DIVI induced by ASOs to date. Preclinical DIVI findings in monkeys have caused considerable delays in development of promising new ASO therapies, because of the uncertainty about whether DIVI in preclinical studies is predictive of effects in humans, and the lack of robust biomarkers of DIVI. This review of DIVI discusses clinical and microscopic features of vasculitis in monkeys, their pathogenic mechanisms, and points to consider for the toxicologist and pathologist when confronted with ASO-related DIVI. Relevant examples of regulatory feedback are included to provide insight into risk assessment of ASO therapies. © 2015 by The Author(s).

  9. 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)

  10. [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.

  11. 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)

  12. 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

  13. Addressing the challenge of high-priced prescription drugs in the era of precision medicine : a systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    NARCIS (Netherlands)

    van der Gronde, T.; Uyl-de Groot, Carin A; Pieters, A.H.L.M.

    2017-01-01

    Context. Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method. A systematic review of Pubmed, the Financial Times,

  14. Addressing the challenge of high-priced prescription drugs in the era of precision medicine : A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

    NARCIS (Netherlands)

    Gronde, T.V. (Toon van der); C.A. Uyl-de Groot (Carin); Pieters, T. (Toine)

    2017-01-01

    markdownabstractCONTEXT: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD: A systematic review of Pubmed, the

  15. 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

  16. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

    Science.gov (United States)

    Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin; Wieseler, Beate

    2015-02-26

    When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The "dossier assessment" is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics ("approved subpopulations"). To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources-that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Retrospective analysis. All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment reports, journal publications, and registry reports

  17. 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

  18. 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

  19. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures.

    Science.gov (United States)

    Kesselheim, Aaron S; Wang, Bo; Studdert, David M; Avorn, Jerry

    2012-01-01

    Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]). One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much

  20. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures.

    Directory of Open Access Journals (Sweden)

    Aaron S Kesselheim

    Full Text Available Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010. We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position and articles (type, connection to off-label use, journal impact factor, citation count/year. We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15% of which contained an adequate disclosure statement. Most articles had no disclosure (43% or did not mention the pharmaceutical company (40%. Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02. Over half of the authors (22/39, 56% made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%].One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is

  1. Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France.

    Science.gov (United States)

    Protiére, Christel; Baker, Rachel; Genre, Dominique; Goncalves, Anthony; Viens, Patrice

    2017-07-01

    The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience. We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry. Three viewpoints emerged, focussing on different dimensions entitled: 1) 'Quality of life (QoL), opportunity cost and participative democracy'; 2)'QoL and patient-centeredness'; and 3) 'Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one. Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

    Directory of Open Access Journals (Sweden)

    Aman Goyal

    2017-01-01

    Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

  7. 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.

  8. 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

  9. 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

  10. Review of regulatory recommendations for orphan drug submissions in the Netherlands and Scotland : focus on the underlying pharmacoeconomic evaluations

    NARCIS (Netherlands)

    Vegter, Stefan; Rozenbaum, Mark H.; Postema, Roelien; Tolley, Keith; Postma, Maarten J.

    2010-01-01

    Background: Pharmacoeconomic evaluations of new drug therapies are often required for reimbursement or guidance decisions. However, for orphan drugs, country-specific requirements exist. In the Netherlands, orphan drug developers can be exempted from providing a full pharmacoeconomic evaluation,

  11. 77 FR 51698 - Authorization To Seize Property Involved in Drug Offenses for Administrative Forfeiture (2012R-9P)

    Science.gov (United States)

    2012-08-27

    ... obtained. In recognition of the link between drug trafficking and many criminal organizations, the Attorney... to combat firearm-related violent crime. The nexus between drug trafficking and firearm violence is... Involved in Drug Offenses for Administrative Forfeiture (2012R-9P) AGENCY: Department of Justice. ACTION...

  12. Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

    Science.gov (United States)

    Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

    2017-04-01

    Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

  13. Unregulated usage of labour-inducing medication in a region of Pakistan with poor drug regulatory control: characteristics and risk patterns.

    Science.gov (United States)

    Shah, Safieh; Van den Bergh, Rafael; Prinsloo, Jeanne Rene; Rehman, Gulalai; Bibi, Amna; Shaeen, Neelam; Auat, Rosa; Daudi, Sabina Mutindi; Njenga, Joyce Wanjiru; Khilji, Tahir Bashir-Ud-Din; Maïkéré, Jacob; De Plecker, Eva; Caluwaerts, Séverine; Zachariah, Rony; Van Overloop, Catherine

    2016-03-01

    In developing countries such as Pakistan, poor training of mid-level cadres of health providers, combined with unregulated availability of labour-inducing medication can carry considerable risk for mother and child during labour. Here, we describe the exposure to labour-inducing medication and its possible risks in a vulnerable population in a conflict-affected region of Pakistan. A retrospective cohort study using programme data, compared the outcomes of obstetric risk groups of women treated with unregulated oxytocin, with those of women with regulated treatment. Of the 6379 women included in the study, 607 (9.5%) received labour-inducing medication prior to reaching the hospital; of these, 528 (87.0%) received unregulated medication. Out of 528 labour-inducing medication administrators, 197 (37.3%) traditional birth attendants (also known as dai) and 157 (29.7%) lady health workers provided unregulated treatment most frequently. Women given unregulated medication who were diagnosed with obstructed/prolonged labour were at risk for uterine rupture (RR 4.1, 95% CI: 1.7-9.9) and severe birth asphyxia (RR 3.9, 95% CI: 2.5-6.1), and those with antepartum haemorrhage were at risk for stillbirth (RR 1.8, 95% CI: 1.0-3.1). In a conflict-affected region of Pakistan, exposure to unregulated treatment with labour-inducing medication is common, and carries great risk for mother and child. Tighter regulatory control of labour-inducing drugs is needed, and enhanced training of the mid-level cadres of healthcare workers is required. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

  14. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).

    Science.gov (United States)

    Brown, Elliot G

    2003-01-01

    The Medical Dictionary for Regulatory Activities (MedDRA) is a unified standard terminology for recording and reporting adverse drug event data. Its introduction is widely seen as a significant improvement on the previous situation, where a multitude of terminologies of widely varying scope and quality were in use. However, there are some complexities that may cause difficulties, and these will form the focus for this paper. Two methods of searching MedDRA-coded databases are described: searching based on term selection from all of MedDRA and searching based on terms in the safety database. There are several potential traps for the unwary in safety searches. There may be multiple locations of relevant terms within a system organ class (SOC) and lack of recognition of appropriate group terms; the user may think that group terms are more inclusive than is the case. MedDRA may distribute terms relevant to one medical condition across several primary SOCs. If the database supports the MedDRA model, it is possible to perform multiaxial searching: while this may help find terms that might have been missed, it is still necessary to consider the entire contents of the SOCs to find all relevant terms and there are many instances of incomplete secondary linkages. It is important to adjust for multiaxiality if data are presented using primary and secondary locations. Other sources for errors in searching are non-intuitive placement and the selection of terms as preferred terms (PTs) that may not be widely recognised. Some MedDRA rules could also result in errors in data retrieval if the individual is unaware of these: in particular, the lack of multiaxial linkages for the Investigations SOC, Social circumstances SOC and Surgical and medical procedures SOC and the requirement that a PT may only be present under one High Level Term (HLT) and one High Level Group Term (HLGT) within any single SOC. Special Search Categories (collections of PTs assembled from various SOCs by

  15. 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)

  16. German Kava Ban Lifted by Court: The Alleged Hepatotoxicity of Kava (Piper methysticum) as a Case of Ill-Defined Herbal Drug Identity, Lacking Quality Control, and Misguided Regulatory Politics.

    Science.gov (United States)

    Kuchta, Kenny; Schmidt, Mathias; Nahrstedt, Adolf

    2015-12-01

    Kava, the rhizome and roots of Piper methysticum, are one of the most important social pillars of Melanesian societies. They have been used for more than 1000 years in social gatherings for the preparation of beverages with relaxing effects. During the colonial period, extract preparations found their way into Western medicinal systems, with experience especially concerning the treatment of situational anxiety dating back more than 100 years. It therefore came as a surprise when the safety of kava was suddenly questioned based on the observation of a series of case reports of liver toxicity in 1999 and 2000. These case reports ultimately led to a ban of kava products in Europe - a ban that has been contested because of the poor evidence of risks related to kava. Only recently, two German administrative courts decided that the decision of the regulatory authority to ban kava as a measure to ensure consumer safety was inappropriate and even associated with an increased risk due to the higher risk inherent to the therapeutic alternatives. This ruling can be considered as final for at least the German market, as no further appeal has been pursued by the regulatory authorities. However, in order to prevent further misunderstandings, especially in other markets, the current situation calls for a comprehensive presentation of the cardinal facts and misconceptions concerning kava and related drug quality issues. Georg Thieme Verlag KG Stuttgart · New York.

  17. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Science.gov (United States)

    Urushihara, Hisashi; Doi, Yuko; Arai, Masaru; Matsunaga, Toshiyuki; Fujii, Yosuke; Iino, Naoko; Kawamura, Takashi; Kawakami, Koji

    2011-01-01

    In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases); this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases). The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases). The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the current discrimination by age and

  18. Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Directory of Open Access Journals (Sweden)

    Hisashi Urushihara

    Full Text Available BACKGROUND: In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases; this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases. The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases. CONCLUSIONS/SIGNIFICANCE: The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question

  19. A Transcriptional Regulatory Network Containing Nuclear Receptors and Long Noncoding RNAs Controls Basal and Drug-Induced Expression of Cytochrome P450s in HepaRG Cells.

    Science.gov (United States)

    Chen, Liming; Bao, Yifan; Piekos, Stephanie C; Zhu, Kexin; Zhang, Lirong; Zhong, Xiao-Bo

    2018-07-01

    Cytochrome P450 (P450) enzymes are responsible for metabolizing drugs. Expression of P450s can directly affect drug metabolism, resulting in various outcomes in therapeutic efficacy and adverse effects. Several nuclear receptors are transcription factors that can regulate expression of P450s at both basal and drug-induced levels. Some long noncoding RNAs (lncRNAs) near a transcription factor are found to participate in the regulatory functions of the transcription factors. The aim of this study is to determine whether there is a transcriptional regulatory network containing nuclear receptors and lncRNAs controlling both basal and drug-induced expression of P450s in HepaRG cells. Small interfering RNAs or small hairpin RNAs were applied to knock down four nuclear receptors [hepatocyte nuclear factor 1 α (HNF1 α ), hepatocyte nuclear factor 4 α (HNF4 α ), pregnane X receptor (PXR), and constitutive androstane receptor (CAR)] as well as two lncRNAs [HNF1 α antisense RNA 1 (HNF1 α -AS1) and HNF4 α antisense RNA 1 (HNF4 α -AS1)] in HepaRG cells with or without treatment of phenobarbital or rifampicin. Expression of eight P450 enzymes was examined in both basal and drug-induced levels. CAR and PXR mainly regulated expression of specific P450s. HNF1 α and HNF4 α affected expression of a wide range of P450s as well as other transcription factors. HNF1 α and HNF4 α controlled the expression of their neighborhood lncRNAs, HNF1 α -AS1 and HNF4 α -AS1, respectively. HNF1 α -AS1 and HNF4 α -AS1 was also involved in the regulation of P450s and transcription factors in diverse manners. Altogether, our study concludes that a transcription regulatory network containing the nuclear receptors and lncRNAs controls both basal and drug-induced expression of P450s in HepaRG cells. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

  20. 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

  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. 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

  3. Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs

    Science.gov (United States)

    McGettigan, Patricia; Roderick, Peter; Mahajan, Rushikesh; Kadam, Abhay; Pollock, Allyson M.

    2015-01-01

    Background In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC) drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO) in violation of rules, and considered that some ambiguity until 1 May 2002 about states’ powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs]), diabetes (metformin), depression/anxiety (anti-depressants/benzodiazepines), and psychosis (anti-psychotics). Methods and Findings This was an ecologic study with a time-trend analysis of FDC sales volumes (2007–2012) and a cross-sectional examination of 2011–2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval (“approved” and “unapproved”), their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011–2012) arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK), and United States of America (US) were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27%) were centrally approved and 90 (73%) were unapproved; metformin: 25 formulations, 20 (80%) approved, five (20%) unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19%) approved, 13 (81%) unapproved

  4. 76 FR 19373 - The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Science.gov (United States)

    2011-04-07

    ... Orange County Regulatory Affairs Discussion Group, Attention to Detail, 5319 University Dr., suite 641... verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after.../ Students.* After May 1, 2011, $725.00 for members, $775.00 for non- members, and $475.00 for FDA/Government...

  5. A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

    Science.gov (United States)

    Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

    2018-06-01

    Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

  6. Establishment of the South-Eastern Norway Regional Health Authority Resource Center for Children with Prenatal Alcohol/Drug Exposure

    Directory of Open Access Journals (Sweden)

    Gro C. C. Løhaugen

    2015-01-01

    Full Text Available This paper presents a new initiative in the South-Eastern Health Region of Norway to establish a regional resource center focusing on services for children and adolescents aged 2–18 years with prenatal exposure to alcohol or other drugs. In Norway, the prevalence of fetal alcohol spectrum (FAS is not known but has been estimated to be between 1 and 2 children per 1000 births, while the prevalence of prenatal exposure to illicit drugs is unknown. The resource center is the first of its kind in Scandinavia and will have three main objectives: (1 provide hospital staff, community health and child welfare personnel, and special educators with information, educational courses, and seminars focused on the identification, diagnosis, and treatment of children with a history of prenatal alcohol/drug exposure; (2 provide specialized health services, such as diagnostic services and intervention planning, for children referred from hospitals in the South-Eastern Health Region of Norway; and (3 initiate multicenter studies focusing on the diagnostic process and evaluation of interventions.

  7. Proyecto Grannacional ALBASALUD para Centro Regulador de Medicamentos Esenciales de los países del ALBA-TCP Grand-national Project ALBASALUD for Regulatory Center of Essential Drugs for the ALBA-TCP countries

    Directory of Open Access Journals (Sweden)

    Celeste Aurora Sánchez González

    2011-09-01

    Full Text Available La Autoridad Reguladora de Medicamentos de Cuba, coordina un Proyecto de la Alianza Bolivariana para los pueblos de América-Tratado de Libre Comercio (ALBA-TCP, dirigido al desarrollo de un Centro Regulador para los países del ALBA como nuevo organismo regional de integración farmacéutica, en aras de contar con un Registro Grannacional válido en todos los países partes, como herramienta para facilitar el acceso a medicamentos esenciales de calidad. Esta investigación tuvo como objetivo diseñar y conducir desde el punto de vista técnico un proyecto para crear las bases legales y metodológicas del futuro centro y sus funciones básicas. Se emplearon técnicas de grupo nominal, puntos de referencia, consultas a expertos y se crearon metodologías específicas para planear y confeccionar los documentos necesarios. Se utilizaron lineamientos de organismos reguladores internacionales, cuadros básicos de medicamentos y reglamentación farmacéutica de los países participantes. Se desarrollaron y aplicaron documentos y estrategias para el trabajo del proyecto durante la etapa de preinversión, se definió el primer listado de medicamentos esenciales del ALBA y se aprobaron las fundamentales disposiciones legales y la reglamentación para las funciones de registro, vigilancia, inspecciones, laboratorios y liberación de lotes. El Proyecto Grannacional ALBASALUD "Centro Regulador de Medicamentos del ALBA-TCP" aplicado ha demostrado su eficiencia y capacidad para alcanzar los objetivos trazados mediante un trabajo científico-técnico con participación colectiva, que ha garantizado las disposiciones y lineamientos requeridos para sus funciones básicas y respaldo legal.The Drug Regulatory Authority of Cuba is coordinating a Project of the Bolivarian Alliance for the Peoples of America- Free Trade Agreement (ALBA-TCP aimed at developing a Regulatory Center that will operate as a new regional body of pharmaceutical integration for the ALBA

  8. Author Details

    African Journals Online (AJOL)

    Gakunju, R. Vol 67 (2013) - Articles Trends and emerging drugs in Kenya: A case study in Mombasa and Nairobi County Abstract PDF. ISSN: 1997-5902. 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 ...

  9. Author Details

    African Journals Online (AJOL)

    Okafor, JO. Vol 10, No 2 (2013) - Articles Prescription pattern of anxiolytic drugs in burn patients: a case study of national orthopaedic hospital, Enugu, Nigeria 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 ...

  10. Author Details

    African Journals Online (AJOL)

    Denooz, Raphaël. Vol 4, No 1 (2017): Series F - Articles Transfer of high performance liquid chromatography with diode array detection method for determination in serum of psychotropic drugs. Abstract PDF. ISSN: 2305-2678. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

  11. Author Details

    African Journals Online (AJOL)

    Aminzadeh, Z. Vol 11, No 17 (2012) - Articles Drug-resistant post-neurosurgical nosocomial Acinetobacter baumannii meningitis in two Iranian hospitals. Abstract PDF. ISSN: 1684-5315. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's ...

  12. Author Details

    African Journals Online (AJOL)

    Minzi, OMS. Vol 11, No 1 (2009) - Articles HIV patients presenting common adverse drug events caused by highly active antiretroviral therapy in Tanzania Abstract PDF. ISSN: 1821-9241. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's ...

  13. Author Details

    African Journals Online (AJOL)

    Bla, KB. Vol 9, No 6 (2010) - Articles PFCRT and DHFR-TS Sequences for Monitoring Drug Resistance in Adzopé Area of Côte d'Ivoire After the Withdrawal of Chloroquine and Pyrimethamine Abstract PDF. ISSN: 1596-9827. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors ...

  14. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

    Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

  15. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  16. A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.

    Science.gov (United States)

    Dalla Torre Di Sanguinetto, Simon; Heinonen, Esa; Antonov, Janine; Bolte, Claus

    2018-01-01

    In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs). The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection. Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%). The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.

  17. 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.

  18. Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya.

    Science.gov (United States)

    Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

    2013-11-01

    The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional

  19. An Assessment of the Efficiency of Government Regulatory Agencies in Nigeria. Case of the National Agency for Food and Drugs Administration and Control

    Directory of Open Access Journals (Sweden)

    Aiwanehi Barbara Ofuani

    2015-09-01

    Full Text Available This study examines Business, Government and Society interrelationships. It eventually narrowed down to assessing the efficiency of government regulatory agencies, in fulfilling the role of government in protecting consumers from unscrupulous practices of businesses. The National Agency for Food and Drugs Administration and Control (NAFDAC was chosen for the study. Since the expectations of the consumers are paramount here, the stakeholder approach method was used for assessing the efficiency of NAFDAC. Literature and previous empirical studies on the topic were examined. For representativeness, data was collected utilizing the survey research design through Questionnaire distributed to 200 respondents in some areas of Lagos Mainland in Lagos state, using the convenience sampling method. 187 copies of the questionnaire representing 93.5% were returned and usable. Descriptive statistics was used to analyze the responses to questions regarding the efficiency of NAFDAC and a hypothesis tested using a one-sample T-test. The findings ran contrary to results from some previous studies. Instead, consumer awareness of the existence of NAFDAC as a regulatory agency and its functions were established, along with a high rate of consumer education. The assessment of its efficiency also showed a high rating. Recommendations were made that the study be replicated in other states of Nigeria and further studies carried out to evaluate its efficiency under previous and current directors for improvement purposes.

  20. Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

    Science.gov (United States)

    Niehaus, Ines; Dintsios, Charalabos-Markos

    2018-03-26

    The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment by contrasting the benefit-risk ratio of EMA and the benefit-harm balance of the HTA jurisdiction. Agreement between market authorization and early benefit assessment is examined by Cohen's kappa (k). 21 of 41 assessments were considered in the analysis. Market authorization is more confirmatory than early benefit assessment because it includes a higher proportion of primary endpoints. The latter implies a primary endpoint to be relevant for the benefit-harm balance in only 67% of cases (0.078). Explorative mortality endpoints reached the highest agreement regarding the mutual consideration for the risk-benefit ratio and the benefit-harm balance (0.000). For explorative morbidity endpoints (-0.600), quality of life (-0.600) and side effects (-0.949) no agreement is ascertainable. To warrant a broader confirmatory basis for decisions supported by HTA, closer inter-institutional cooperation of approval authorities and HTA jurisdictions by means of reliable joint advice for manufacturers regarding endpoint definition would be favorable. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. 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.

  2. 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)

  3. First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan - Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

    Science.gov (United States)

    Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

    2018-05-25

    A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

  4. Food irradiation regulatory development in the U.S

    International Nuclear Information System (INIS)

    Miller, S.A.; Coleman, E.C.

    1985-01-01

    The Food and Drug Administration's involvement in food irradiation dates back more than thirty years. The agency has been involved with the wholesomeness testing of the irradiated foods from both nutritional and toxicological standpoints. Knowledge about the nutritional and toxicological aspects of irradiated foods is fundamental in the development of a regulatory strategy for assuring the safe use of such foods. (author)

  5. 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)

  6. [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

  7. 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...

  8. 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)

  9. 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)

  10. Examination of why some community pharmacists do not provide 72-hour emergency prescription drugs to Medicaid patients when prior authorization is not available.

    Science.gov (United States)

    Shepherd, Marvin D

    2013-09-01

    Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist's role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply. To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available. A questionnaire was mailed to selected Texas community pharmacies. The instrument was developed by the researcher and reviewed by the Texas Medicaid Vendor Drug Program staff. The University of Texas, Office of Survey Research collected the data in September and October of 2011 by mail and online. The data were forwarded to the researcher for analyses. A total of 788 identified community pharmacies were mailed a packet containing 3 questionnaires to be completed by the pharmacist-in-charge, a staff pharmacist, and a pharmacy technician. There were 2 mailings of the questionnaire packet and follow-up telephone calls to nonrespondents. A total of 653 questionnaires were completed and returned from 288 community pharmacies (36.7%) out of 788 pharmacies that were mailed the questionnaire packets. A total of 368 (57.5%) completed questionnaires came from chain store pharmacy respondents and 272 (42.5%) questionnaires from independent pharmacy respondents. A total of 21.3% (n = 134) of the respondents indicated that they were not aware of the federal and state requirement to dispense a 72-hour emergency supply of a prescription drug to Medicaid patients when prior authorization (PA) is not available. A greater proportion of the chain store respondents (26.6%) were unaware of the requirement compared with the

  11. 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.

  12. 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)

  13. 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...

  14. QT interval correction for drug-induced changes in body temperature during integrated cardiovascular safety assessment in regulatory toxicology studies in dogs: A case study.

    Science.gov (United States)

    El Amrani, Abdel-Ilah; El Amrani-Callens, Francine; Loriot, Stéphane; Singh, Pramila; Forster, Roy

    2016-01-01

    Cardiovascular safety assessment requires accurate evaluation of QT interval, which depends on the length of the cardiac cycle and also on core body temperature (BT). Increases in QT interval duration have been shown to be associated with decreases in BT in dogs. An example of altered QT interval duration associated with changes in body temperature observed during a 4-week regulatory toxicology study in dogs is presented. Four groups of Beagle dogs received the vehicle or test item once on Day 1, followed by a 4-week observation period. Electrocardiogram (ECG) parameters were continuously recorded on Days 1 and 26 by jacketed external telemetry (JET). Core body temperature (BT) was measured with a conventional rectal thermometer at appropriate time-points during the Day 1 recording period. Decreased BT was observed approximately 2h after treatment on Day 1, along with increased QT interval duration corrected according to the Van de Water formula (QTcV), but the effect was no longer observed after correction for changes in BT [QTcVcT=QTcV-14(37.5-BT)] according to the Van der Linde formula. No significant changes in QTcV were reported at the end of the observation period, on Day 26. The present study demonstrates that core body (rectal) temperature can easily be monitored at appropriate time-points during JET recording in regulatory toxicology studies in dogs, in order to correct QT interval duration values for treatment-related changes in BT. The successful application of the Van der Linde formula to correct QTc prolongation for changes in BT was demonstrated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  15. The FDA “Deeming Rule” and Tobacco Regulatory Research

    OpenAIRE

    Backinger, Cathy L.; Meissner, Helen I.; Ashley, David L.

    2016-01-01

    In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA’s Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of...

  16. 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)

  17. 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)

  18. 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

  19. Lactobacillus plantarum Strains Can Enhance Human Mucosal and Systemic Immunity and Prevent Non-steroidal Anti-inflammatory Drug Induced Reduction in T Regulatory Cells

    Science.gov (United States)

    de Vos, Paul; Mujagic, Zlatan; de Haan, Bart J.; Siezen, Roland J.; Bron, Peter A.; Meijerink, Marjolein; Wells, Jerry M.; Masclee, Ad A. M.; Boekschoten, Mark V.; Faas, Marijke M.; Troost, Freddy J.

    2017-01-01

    Orally ingested bacteria interact with intestinal mucosa and may impact immunity. However, insights in mechanisms involved are limited. In this randomized placebo-controlled cross-over trial, healthy human subjects were given Lactobacillus plantarum supplementation (strain TIFN101, CIP104448, or WCFS1) or placebo for 7 days. To determine whether L. plantarum can enhance immune response, we compared the effects of three stains on systemic and gut mucosal immunity, by among others assessing memory responses against tetanus toxoid (TT)-antigen, and mucosal gene transcription, in human volunteers during induction of mild immune stressor in the intestine, by giving a commonly used enteropathic drug, indomethacin [non-steroidal anti-inflammatory drug (NSAID)]. Systemic effects of the interventions were studies in peripheral blood samples. NSAID was found to induce a reduction in serum CD4+/Foxp3 regulatory cells, which was prevented by L. plantarum TIFN101. T-cell polarization experiments showed L. plantarum TIFN101 to enhance responses against TT-antigen, which indicates stimulation of memory responses by this strain. Cell extracts of the specific L. plantarum strains provoked responses after WCFS1 and TIFN101 consumption, indicating stimulation of immune responses against the specific bacteria. Mucosal immunomodulatory effects were studied in duodenal biopsies. In small intestinal mucosa, TIFN101 upregulated genes associated with maintenance of T- and B-cell function and antigen presentation. Furthermore, L. plantarum TIFN101 and WCFS1 downregulated immunological pathways involved in antigen presentation and shared downregulation of snoRNAs, which may suggest cellular destabilization, but may also be an indicator of tissue repair. Full sequencing of the L. plantarum strains revealed possible gene clusters that might be responsible for the differential biological effects of the bacteria on host immunity. In conclusion, the impact of oral consumption L. plantarum on

  20. Lactobacillus plantarum Strains Can Enhance Human Mucosal and Systemic Immunity and Prevent Non-steroidal Anti-inflammatory Drug Induced Reduction in T Regulatory Cells

    Directory of Open Access Journals (Sweden)

    Paul de Vos

    2017-08-01

    Full Text Available Orally ingested bacteria interact with intestinal mucosa and may impact immunity. However, insights in mechanisms involved are limited. In this randomized placebo-controlled cross-over trial, healthy human subjects were given Lactobacillus plantarum supplementation (strain TIFN101, CIP104448, or WCFS1 or placebo for 7 days. To determine whether L. plantarum can enhance immune response, we compared the effects of three stains on systemic and gut mucosal immunity, by among others assessing memory responses against tetanus toxoid (TT-antigen, and mucosal gene transcription, in human volunteers during induction of mild immune stressor in the intestine, by giving a commonly used enteropathic drug, indomethacin [non-steroidal anti-inflammatory drug (NSAID]. Systemic effects of the interventions were studies in peripheral blood samples. NSAID was found to induce a reduction in serum CD4+/Foxp3 regulatory cells, which was prevented by L. plantarum TIFN101. T-cell polarization experiments showed L. plantarum TIFN101 to enhance responses against TT-antigen, which indicates stimulation of memory responses by this strain. Cell extracts of the specific L. plantarum strains provoked responses after WCFS1 and TIFN101 consumption, indicating stimulation of immune responses against the specific bacteria. Mucosal immunomodulatory effects were studied in duodenal biopsies. In small intestinal mucosa, TIFN101 upregulated genes associated with maintenance of T- and B-cell function and antigen presentation. Furthermore, L. plantarum TIFN101 and WCFS1 downregulated immunological pathways involved in antigen presentation and shared downregulation of snoRNAs, which may suggest cellular destabilization, but may also be an indicator of tissue repair. Full sequencing of the L. plantarum strains revealed possible gene clusters that might be responsible for the differential biological effects of the bacteria on host immunity. In conclusion, the impact of oral consumption L

  1. [The effects of various factors on the in vitro velocity of drug release from repository tablets. Part 4: Isoniazid (Rimicid) respository tablets (author's transl)].

    Science.gov (United States)

    Tomassini, L; Michailova, D; Naplatanova, D; Slavtschev, P

    1979-12-01

    The authors investigated the release of isoniazid from repository tablets as related to form, processing technology, strength constant and storage for 5 years. On determining the diffusion coefficient (D), the initial dissolution rate (Vo) and the time required for the diffusion of the releasing medium to the middle of the tablet (t1/2), it was found that the difference in release rate between the flat and the biconvex tablets is small. Furthermore, it was stated that the three-layer tablets have very high D and Vo values and very low t1/2 values, for what reason they are unsuited for repository tablets of the composition under investigation. Moreover, it was found that an increase of the strength constant does not affect the D, t1/2 and Vo values, and that the release of isoniazid is retarded only in flat tablets with the highest strength constant. Storage exerts no effect on the drug release from these tablets. The industrial production of these tablets is under way.

  2. Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

    2017-12-01

    The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

  3. 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

  4. Information for Consumers (Drugs)

    Science.gov (United States)

    ... approved drugs Drugs@FDA Information on FDA-approved brand name and generic drugs including labeling and regulatory history Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, ...

  5. Drug Control

    Science.gov (United States)

    Leviton, Harvey S.

    1975-01-01

    This article attempts to assemble pertinent information about the drug problem, particularily marihuana. It also focuses on the need for an educational program for drug control with the public schools as the main arena. (Author/HMV)

  6. The Regulatory Evaluation of Vaccines for Human Use.

    Science.gov (United States)

    Baylor, Norman W

    2016-01-01

    A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive characterization and testing. Special expertise and procedures are needed for their manufacture, control, and regulation. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use.The Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases. Authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C). Vaccines are regulated as biologics and licensed based on the demonstration of safety and effectiveness. The

  7. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2016-06-01

    information: Each author's highest academic degrees should be listed, although some journals do not publish these. The name of the department(s and institution(s or organizations where the work should be attributed should be specified. Most electronic submission systems require that authors provide full contact information, including land mail and e-mail addresses, but the title page should list the corresponding authors' telephone and fax numbers and e-mail address. ICMJE encourages the listing of authors’ Open Researcher and Contributor Identification (ORCID. Disclaimers. An example of a disclaimer is an author's statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder. Source(s of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of the article itself. Word count. A word count for the paper's text, excluding its abstract, acknowledgments, tables, figure legends, and references, allows editors and reviewers to assess whether the information contained in the paper warrants the paper's length, and whether the submitted manuscript fits within the journal's formats and word limits. A separate word count for the Abstract is useful for the same reason. Number of figures and tables. Some submission systems require specification of the number of Figures and Tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all figures and tables were actually included with the manuscript and, because Tables and Figures occupy space, to assess if the information provided by the figures and tables warrants the paper's length and if the manuscript fits within the journal's space limits. Conflict of Interest declaration. Conflict of interest information for each author needs to be part of the manuscript; each journal should develop standards with regard to the

  8. 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- ...

  9. 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 ...

  10. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2015-12-01

    numbers and e-mail address. ICMJE encourages the listing of authors’ Open Researcher and Contributor Identification (ORCID. Disclaimers. An example of a disclaimer is an author's statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder. Source(s of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of the article itself. Word count. A word count for the paper's text, excluding its abstract, acknowledgments, tables, figure legends, and references, allows editors and reviewers to assess whether the information contained in the paper warrants the paper's length, and whether the submitted manuscript fits within the journal's formats and word limits. A separate word count for the Abstract is useful for the same reason. Number of figures and tables. Some submission systems require specification of the number of Figures and Tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all figures and tables were actually included with the manuscript and, because Tables and Figures occupy space, to assess if the information provided by the figures and tables warrants the paper's length and if the manuscript fits within the journal's space limits. Conflict of Interest declaration. Conflict of interest information for each author needs to be part of the manuscript; each journal should develop standards with regard to the form the information should take and where it will be posted. The ICMJE has developed a uniform conflict of interest disclosure form for use by ICMJE member journals and the ICMJE encourages other journals to adopt it. Despite availability of the form, editors may require conflict of interest declarations on the manuscript title page to save the work of collecting forms from each author prior to making an editorial decision or to save

  11. Author Details

    African Journals Online (AJOL)

    Bangalee, Varsha. Vol 21, No 1 (2016) - Articles Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa? Abstract PDF · Vol 22, No 1 (2017) - Articles Cost-savings accruable to removing value added tax from antiretrovirals in the South African private health sector

  12. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

    International Nuclear Information System (INIS)

    Briand, S.

    2008-03-01

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  13. Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

    Science.gov (United States)

    Mühlebach, Stefan; Borchard, Gerrit; Yildiz, Selcan

    2015-03-01

    Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.

  14. Defining Tobacco Regulatory Science Competencies.

    Science.gov (United States)

    Wipfli, Heather L; Berman, Micah; Hanson, Kacey; Kelder, Steven; Solis, Amy; Villanti, Andrea C; Ribeiro, Carla M P; Meissner, Helen I; Anderson, Roger

    2017-02-01

    In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  15. Author Details

    African Journals Online (AJOL)

    Persea americana) seeds and fluted pumpkin (Telfairia occidentalis) leaves coadministered with anti-tuberculosis drugs on liver enzymes of albino rats. Abstract PDF. ISSN: 2006-6996. AJOL African Journals Online. HOW TO USE AJOL.

  16. Author Details

    African Journals Online (AJOL)

    Azadirachta indica) on Bacteria Isolated from Adult Mouth Abstract PDF · Vol 20, No 2 (2012) - Articles Microbiological Quality of some Expired Drugs in Sokoto Metropolis, Nigeria Abstract PDF. ISSN: 0794-5698. AJOL African Journals Online.

  17. Author Details

    African Journals Online (AJOL)

    Effect of alcohol and kolanut interaction on brain sodium pump activity in wistar albino rats. Abstract PDF · Vol 22, ... Effect of caffeine -coconut products interactions on induction of microsomal drug-metabolizing enzymes in wistar albino rats

  18. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. 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.

  20. 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...

  1. 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.

  2. 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)

  3. 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.

  4. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.

    Science.gov (United States)

    Cornelius, Victoria R; Liu, Kun; Peacock, Janet; Sauzet, Odile

    2016-03-20

    To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe. For each drug, data were extracted from the US Product Inserts and the European Summary of Product Characteristics documents between 09/2013 and 01/2015. Individuals contributing ADR information to product information documents. All ADRs reported in product information sections 5 and 6 (USA), and 4·4 and 4·8 (Europe). Twelve brand drugs--24 paired documents--were included. On average, there were 77 more ADRs reported in the USA compared with in the European product information document, with a median number of 201 ADRs (range: 65-425) and 114 (range: 56-265), respectively. More product information documents in the USA reported information on the source of evidence (10 vs 5) and risk (9 vs 5) for greater than 80% of ADRs included in the document. There was negligible information included regarding duration, severity, reversibility or recurrence of ADRs. On average, only 29% of ADR terms were reported in both paired documents. Product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity and reversibility. The ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug. Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. In order for prescribers to provide considered risk-benefit advice across competing drug therapies to patients, they need access to comprehensible and reliable ADR information. Published by the BMJ Publishing Group Limited

  5. Nonimaging detectors in drug development and approval.

    Science.gov (United States)

    Wagner, H N

    2001-07-01

    Regulatory applications for imaging biomarkers will expand in proportion to the validation of specific parameters as they apply to individual questions in the management of disease. This validation is likely to be applicable only to a particular class of drug or a single mechanism of action. Awareness among the world's regulatory authorities of the potential for these emerging technologies is high, but so is the cost to the sponsor (including the logistics of including images in a dossier), and therefore the pharmaceutical industry must evaluate carefully the potential benefit of each technology for its drug development programs, just as the authorities must consider carefully the extent to which the method is valid for the use to which the applicant has put it. For well-characterized tracer systems, it may be possible to design inexpensive cameras that make rapid assessments.

  6. 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)

  7. 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

  8. 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.

  9. 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)

  10. 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...

  11. Off-Label Drug Use in Pediatric Practice: Unsolved Problems

    Directory of Open Access Journals (Sweden)

    A. R. Titova

    2015-01-01

    Full Text Available The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.

  12. Author Details

    African Journals Online (AJOL)

    Shaaban, MI. Vol 39, No 1 (2014) - Articles Comparative studies on different molecular methods for epidemiological typing of multi-drug-resistance Klebsiella pneumoniae isolated from Mansoura hospitals. Abstract · Vol 39, No 1 (2014) - Articles Production of DNA polymerase by recombinant pET-17b/Pfu-Pol and its ...

  13. Author Details

    African Journals Online (AJOL)

    Okemo, P.O.. Vol 94, No 1 (2017) - Articles Contamination of the minnow Rastrineobola argenta, through handling at landing sites and retail markets around Lake Victoria Abstract · Vol 94, No 3 (2017) - Articles Multiple drug resistance Staphylococcus aureus isolated in foods of animal origin in Nairobi, Kenya Abstract.

  14. Author Details

    African Journals Online (AJOL)

    McCurdy, S. Vol 10, No 1 (2011) - Articles HIV risk behaviours, perceived severity of drug use problems, and prior treatment experience in a sample of young heroin injectors in Dar es Salaam, Tanzania. Abstract PDF. ISSN: 1531-4065. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians ...

  15. Author Details

    African Journals Online (AJOL)

    Kamau, FN. Vol 6, No 3 (2003) - Articles Quality of Amoxycillin Preparations on the Kenyan Market Abstract PDF · Vol 10, No 3 (2007) - Articles Quality of Antimalarial Drugs Analysed in the National Quality Control Laboratory during the Period 2002–2005. Abstract PDF · Vol 11, No 2 (2008) - Articles Phytosterols from the ...

  16. Author Details

    African Journals Online (AJOL)

    Makhtar, M. Vol 9, No 6S (2017) - Articles A classification framework for drug relapse prediction. Abstract PDF · Vol 9, No 6S (2017) - Articles Selection of classification models from repository of model for water quality dataset. Abstract PDF · Vol 9, No 6S (2017) - Articles Churn classification model for local telecommunication ...

  17. Author Details

    African Journals Online (AJOL)

    Jones, ESW. Vol 105, No 3 (2015) - Articles Hypertension, end-stage renal disease and mesangiocapillary glomerulonephritis in methamphetamine users. Abstract PDF · Vol 107, No 10 (2017) - Articles Therapeutic drug monitoring of amlodipine and the Z-FHL/HHL ratio: Adherence tools in patients referred for apparent ...

  18. Author Details

    African Journals Online (AJOL)

    Abstract PDF · Vol 1, No 4 (2012) - Articles The combined incidence of Grade II and Grade IV astrocytoma in the brain of rats fed with diet containing Yaji: A complex Nigerian Suya meat sauce ... Abstract PDF · Vol 3, No 4 (2014) - Articles Human diseases and histories of treatment-drug lacunae: An Ebola induced reflection

  19. Author Details

    African Journals Online (AJOL)

    Arhewoh, M.I.. Vol 14, No 3 (2017) - Articles Modulatory effect of polymer type and composition on drug release from sustained release matrix tablets of diclofenac sodium. Abstract · Vol 14, No 3 (2017) - Articles Box Behnken design in the optimization of two disintegrants and a sublimating agent in the formulation of fast ...

  20. Author Details

    African Journals Online (AJOL)

    Antiretroviral Drug as a Cause of Bilateral Avascular Necrosis of the Femoral Head Abstract · Vol 11, No 1 (2012) - Articles Knowledge and Attitude of Healthcare Workers Towards Traditional Bone Setters In Benue State Abstract · Vol 11, No 2 (2012) - Articles Aetiological Factors in Limb Amputation: The Changing Pattern!

  1. Author Details

    African Journals Online (AJOL)

    Uzondu, ALE. Vol 10, No 2 (2013) - Articles Antimicrobial spectra and activities of antibiotic substances from Streptomyces species against sensitive and resistant microorganisms. Abstract · Vol 10, No 2 (2013) - Articles Prescription pattern of anxiolytic drugs in burn patients: a case study of national orthopaedic hospital, ...

  2. Author Details

    African Journals Online (AJOL)

    Karangwa, Charles. Vol 4, No 1 (2017): Series F - Articles Transfer of high performance liquid chromatography with diode array detection method for determination in serum of psychotropic drugs. Abstract PDF. ISSN: 2305-2678. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians ...

  3. Author Details

    African Journals Online (AJOL)

    Relationship between firewood usage and urinary Cr, Cu and As in informal areas of Cape Town Abstract PDF · Vol 105, No 3 (2015) - Articles Prevalence and causes of thrombocytopenia in an academic state sector laboratory in Soweto, Johannesburg, South Africa Abstract PDF · Vol 105, No 4 (2015) - Articles Drugs and ...

  4. Author Details

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain Abstract PDF · Vol 31, No 2 (2014) - Articles A review of pregnancy outcomes following laparoscopic ovarian drilling for infertile women with clomiphene resistant polycystic ovarian ...

  5. Author Details

    African Journals Online (AJOL)

    Ofoefule, SI. Vol 11 (2006) - Articles In vitro evaluation and application of Carbopol 940- tragacanth binary mixtures in the formulation of bio-adhesive hyoscine hydrobromide tablet. Abstract PDF · Vol 9 (2004) - Articles Use of mathematical approximationns in the elucidation of drug release mechanisms from a high viscosity ...

  6. Author Details

    African Journals Online (AJOL)

    Iwuagwu, M.A.. Vol 14, No 3 (2017) - Articles Modulatory effect of polymer type and composition on drug release from sustained release matrix tablets of diclofenac sodium. Abstract · Vol 14, No 3 (2017) - Articles Box Behnken design in the optimization of two disintegrants and a sublimating agent in the formulation of fast ...

  7. Author Details

    African Journals Online (AJOL)

    Okoye, IP. Vol 14, No 1 (2008) - Articles The effect of stability treatmetn on the surface energetics of inhalation grade lactose. Abstract PDF · Vol 14, No 4 (2008) - Articles Investigations Of Powder Surface Properties Of Drug Substances Using Inverse Gas Chromatography (IGC) Abstract PDF · Vol 15, No 1 (2009) - Articles

  8. Author Details

    African Journals Online (AJOL)

    Evaluation of the Release Profiles of Ibuprofen Formulated from Carnuba Wax and Homolipid Capra hircus. Abstract PDF · Vol 4, No 1 (2011) - Articles In Vitro Assessment of Quality Control Parameters of Some Commercially Available Generics of Amlodipine Besylate in Nigerian Drug Market Abstract PDF. ISSN: 1596- ...

  9. 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)

  10. 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)

  11. 21 CFR 312.86 - Focused FDA regulatory research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

  12. 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 ...

  13. 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. ... 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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    African Journals Online (AJOL)

    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. ... Iliopsoas haematoma in a rugby player. Abstract PDF · Vol 29, No 1 (2017) - Articles The use of negative pressure wave treatment in athlete recovery. Abstract PDF. ISSN: 2078-516X. AJOL African ...

  17. 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. ... 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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    African Journals Online (AJOL)

    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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    African Journals Online (AJOL)

    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Duwa, S S. Vol 8 (2004) - Articles Lower hybrid waves instability in a velocity–sheared inhomogenous charged dust beam. Abstract · Vol 9 (2005) - Articles The slide away theory of lower hybrid bursts

  1. 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. ... Vol 45 (2016) - Articles From vectors to waves and streams: An alternative approach to semantic maps1. Abstract PDF · Vol 48 (2017) - Articles Introduction: 'n Klein ietsie for Johan Oosthuizen

  2. 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. ... to blast loadings. Abstract PDF · Vol 9, No 3S (2017): Special Issue - Articles Experimental and numerical investigation on blast wave propagation in soil structure. Abstract PDF. ISSN: 1112-9867.

  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. ... 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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    African Journals Online (AJOL)

    Author Details. Journal Home > Advanced Search > Author Details. Log in or Register to get access to full text downloads. ... Vol 29, No 1 (2017) - Articles 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 ...

  5. 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....

  6. 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....

  7. 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.

  8. 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

  9. [The study of developmental pharmacology (I). Effect of pentazocine HCl on the physiology of rats given the drug during perinatal and postnatal periods (author's transl)].

    Science.gov (United States)

    Fukawa, K; Sawabe, T; Kawano, O; Hatanaka, Y

    1978-01-01

    The effects of drug administration on the dams (F0) and their offspring (F1), particularly on the central nervous and reproductive functions of F1, were studied by oral administration of pentazocine HCl to rats during the perinatal and postnatal periods. No significant differences were observed between administered and control rats regarding body weight changes and food intake during perinatal and postnatal periods in F0 at all dosages, but temporary salivation was observed in the 200 and 100 mg/kg groups, and decline of spontaneous activity and respiratory rate, disappearance of righting reflex, clonic convulsion were observed in some of the 200 mg/kg group. No significant differences were observed regarding litter size, birth rate, state and timing of differentiation as postnatal development, sex maturity, reproductive function in F1, although some groups were slightly inferior in body weight at birth and during the nursing period. Furthermore, no differences were observed in respect to the nervous functions of balance, exercise and psychotic related activity in the open-field test.

  10. 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 ...

  11. Author Details

    African Journals Online (AJOL)

    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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    African Journals Online (AJOL)

    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 ...

  13. Author Details

    African Journals Online (AJOL)

    , 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 ...

  14. Author Details

    African Journals Online (AJOL)

    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.

  15. Author Details

    African Journals Online (AJOL)

    , 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 ...

  16. 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 ...

  17. 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

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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 ...

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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 ...

  20. 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 ...

  1. 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- ...

  2. 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 ...

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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

  4. Author Details

    African Journals Online (AJOL)

    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.

  5. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

    Science.gov (United States)

    Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

    2014-01-01

    International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

  6. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants.

    Science.gov (United States)

    Klátyik, Szandra; Bohus, Péter; Darvas, Béla; Székács, András

    2017-01-01

    Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU), and the occurrence of veterinary drug (VD) and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually) initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively), and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively). Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants) and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects between the

  7. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants

    Directory of Open Access Journals (Sweden)

    Szandra Klátyik

    2017-09-01

    Full Text Available Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU, and the occurrence of veterinary drug (VD and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively, and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively. Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects

  8. 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.

  9. [Orphan drugs].

    Science.gov (United States)

    Golocorbin Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojsa; Mikov, Momir

    2013-01-01

    Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in "adopting" them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. THE BEGINNING OF ORPHAN DRUGS DEVELOPMENT: This problem was first recognized by Congress of the United States of America in January 1983, and when the "Orphan Drug Act" was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs.

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