Towards a single European electricity market. A structured approach to regulatory mode decision-making

International Nuclear Information System (INIS)

De Jong, H.M.

2009-01-01

This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory mode (process) for dealing effectively with market integration issues. This unstructured approach to regulatory mode selection leads to several problems: - Today's trial-and-error strategy of shifting from one regulatory mode to another is time-consuming. - In the regulatory mode selection process, certain key principles of good governance are insufficiently considered. - European regulatory processes are experienced as vague, intransparent, and illegitimate by 'outside' stakeholders. This study develops a 'structured approach to regulatory mode decision-making' (STARMODE) based on the theory of decision modelling in policy management and a case study exploring three key market integration issues in the field of electricity markets: interconnector investment, congestion management and market transparency. The main objective is to present a systematic and comprehensive framework for analysing and improving regulatory mode decision-making in the context of the European Union, focusing on electricity market integration. The STARMODE approach is generally applicable to (and relevant for) European market integration issues in industries characterized by a natural monopoly and/or an essential service. The approach may also contribute to national regulatory mode decision-making and multi-state decision-making in other continents.

A critical assessment of the Hong Kong Government's proposed post-2008 regulatory regime for local electricity utilities

International Nuclear Information System (INIS)

Woo, Chi-Keung; Horowitz, Ira; Tishler, Asher

2006-01-01

In December 2005, the Hong Kong Government issued a 'Consultation Paper on Future Development of the Electricity Markets in Hong Kong: Stage II Consultation,' proposing a post-2008 regulatory regime upon the expiration of the existing regulatory contract between the Hong Kong Government and each of the two local electricity utilities. We assess the proposal using the criteria of safe, reliable, and environmentally friendly service at the lowest rates that will allow the utilities reasonable returns on their investments. We caution that if fully adopted, the highly risky proposal may lead to less-reliable service without the compensating benefits to the environment

Nuclear regulatory challenges arising from competition in electricity markets

International Nuclear Information System (INIS)

2001-01-01

In recent years a world-wide trend has been developing to introduce competition in electricity markets. As market competition unfolds, it produces a wide range of safety challenges for nuclear power plant operators and regulators. Nuclear regulators must be aware of the potential safety challenges produced and consider whether new regulatory response strategies are warranted. This report describes many of these challenges, their implications and possible regulatory response strategies. The intended audience is primarily nuclear safety regulators, although government authorities, nuclear power plant operators and the general public may also be interested. (author)

Design and analysis of post-marketing research.

Science.gov (United States)

Zhou, Xiao-Hua Andrew; Yang, Wei

2013-07-01

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

Science.gov (United States)

Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

2018-06-01

Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

Emerging Markets: Theory & Practice / Turkey’s Reforms Post 2001 Crisis

Directory of Open Access Journals (Sweden)

Duygu Uckun

2010-01-01

Full Text Available The global financial downturn of 2001 affected broad swaths of the increasingly interconnected global economy. The global effects of the economic downturn in the U.S. in 2008 showed that decoupling had not occurred to the extent many thought, and showed that indeed emerging market countries, including Turkey, were not immune from economic trouble in America. This paper addresses the question, whether the fiscal, financial, and regulatory reforms in Turkey after the 2001 economic crisis cushion the global financial crisis world is facing toward the end of the decade. In doing so we analyze the policies implemented by Turkey before and after the 2001 global economic crisis and identify the successes as well as failures of those reforms. The results of our research show that despite significant reforms in key economic and regulatory areas in the post-2001 crisis period, vulnerabilities remained; especially concerning the large current account deficit, volatility of exchange rates, increased private sector indebtedness, and persistent unemployment. These vulnerabilities will be visible in the deteriorating liquidity conditions in the global financial markets. We conclude by recommending infrastructure, education and health spending as well as restructuring of the economy to further attract FDI and avoid reliance on speculative foreign capital in order to achieve a more balanced and sustained growth in the long run.

Market segmentation and analysis of Japan's residential post and beam construction market.

Science.gov (United States)

Joseph A. Roos; Ivan L. Eastin; Hisaaki Matsuguma

2005-01-01

A mail survey of Japanese post and beam builders was conducted to measure their level of ethnocentrism, market orientation, risk aversion, and price consciousness. The data were analyzed utilizing factor and cluster analysis. The results showed that Japanese post and beam builders can be divided into three distinct market segments: open to import...

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

Science.gov (United States)

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

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...

Energy market opportunities post-Maui

International Nuclear Information System (INIS)

Saha, G.

1995-01-01

As supply from the Maui and other existing producing fields decline, petroleum explorers and developers need to address the question who will be the indigenous oil and gas customers post Maui? This paper discusses major macro- and micro-environmental trends which will influence likely market opportunities. Two sub-markets are examined. First, what trends impact on current oil and gas customers. Second, what other new customers might arise. The macro-environment trends cover important economic, political, legislation, socio-economic and technical parameters. The micro-environment trends cover energy market structures and pricing parameters. (Author)

Low-rank coal study. Volume 4. Regulatory, environmental, and market analyses

Energy Technology Data Exchange (ETDEWEB)

1980-11-01

The regulatory, environmental, and market constraints to development of US low-rank coal resources are analyzed. Government-imposed environmental and regulatory requirements are among the most important factors that determine the markets for low-rank coal and the technology used in the extraction, delivery, and utilization systems. Both state and federal controls are examined, in light of available data on impacts and effluents associated with major low-rank coal development efforts. The market analysis examines both the penetration of existing markets by low-rank coal and the evolution of potential markets in the future. The electric utility industry consumes about 99 percent of the total low-rank coal production. This use in utility boilers rose dramatically in the 1970's and is expected to continue to grow rapidly. In the late 1980's and 1990's, industrial direct use of low-rank coal and the production of synthetic fuels are expected to start growing as major new markets.

Some Implications of New Regulatory Measures for Euro Area Money Markets

OpenAIRE

Doran, David; Kirrane, Caroline; Masterson, Mary

2014-01-01

A number of banking and financial market regulations have been proposed in response to the financial crisis; in particular the Basel III solvency and liquidity rules. These enhanced regulatory standards intend to ensure that banks and banking systems are significantly more resilient in the future than was the case in the run-up to the financial crisis. However, there have been concerns that the extent and range of the new regulatory measures may lead to unintended shifts in market behaviour. ...

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

Science.gov (United States)

Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

2018-01-15

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Science.gov (United States)

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

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.

The development of market power in the Spanish power generation sector: Perspectives after market liberalization

International Nuclear Information System (INIS)

Ciarreta, Aitor; Nasirov, Shahriyar; Silva, Carlos

2016-01-01

This paper provides a comprehensive analysis of the market power problem in the Spanish power generation sector and examines how and to which extent the market has developed in terms of market power concerns after the market liberalization reforms. The methodology applied in this study includes typical ex-post structural and behavioral measures employed to estimate potential for market power, namely: concentration ratios (CR) (for the largest and the three largest suppliers), the Herfindahl–Hirschman Index (HHI), Entropy, Pivotal Supply Index, the Residual Supply Index and Residual Demand Elasticity (RDE). The results are presented for the two largest Spanish generating companies (Endesa and Iberdrola) acting in the Iberian Electricity Market (MIBEL), and in the Spanish Day-ahead electricity market. The results show evidence that these companies have behaved much more competitively in recent periods than in the beginning of the market liberalization. In addition, the paper discusses important structural and regulatory changes through market liberalization processes in the Spanish Day-ahead electricity market. - Highlights: •Competition and regulation in the Spanish electricity market. •The methodology applied in this study: ex-post structural and behavioral measures. •Key dominant companies behaved more competitively in recent periods. •Important structural and regulatory changes in the Spanish electricity market.

Switzerland; Financial Sector Assessment Program: Factual Update: Insurance Sector Market and Regulatory Developments

OpenAIRE

International Monetary Fund

2007-01-01

This paper presents a factual update of the Insurance Core Principles including insurance sector market and regulatory developments for Switzerland. Regulatory reforms since 2003 have updated Switzerland’s regulatory and supervisory regime for the insurance industry to bring it in line with international best practices. The Insurance Supervision Law (ISL) has reoriented the regulatory focus and expanded the regulatory scope to include group/conglomerate supervision, corporate governance, risk...

Direct-to-consumer stem cell marketing and regulatory responses.

Science.gov (United States)

Sipp, Douglas

2013-09-01

There is a large, poorly regulated international market of putative stem cell products, including transplants of processed autologous stem cells from various tissues, cell processing devices, cosmetics, and nutritional supplements. Despite the absence of rigorous scientific research in the form of randomized clinical trials to support the routine use of such products, the market appears to be growing and diversifying. Very few stem cell biologics have passed regulatory scrutiny, and authorities in many countries, including the United States, have begun to step up their enforcement activities to protect patients and the integrity of health care markets.

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

Regulatory barriers for activating flexibility in the Nordic-Baltic electricity market

DEFF Research Database (Denmark)

Bergaentzlé, Claire; Skytte, Klaus; Soysal, Emilie Rosenlund

2017-01-01

to flexibility. We find that the most restrictive barriers against flexibility are emitted by public authorities as part of broader policy strategies. Overall, we find that current regulatory and market framework conditions do not hinder flexibility. However, despite that, flexibility remains limited due......, load adjustment or to a greater coupling to other energy sectors. In this paper, we identify the framework conditions that influence the provision of VRE-friendly flexibility in the Nordic and Baltic electricity sector, i.e., the market and regulatory settings that act as drivers or barriers...... to a lack of coherent instruments intended to both the demand and supply-side to effectively act flexibly....

Analysing success of regulatory policy transfers: Evidence from Turkish energy markets

International Nuclear Information System (INIS)

Dastan, Seyit Ali

2011-01-01

Economic regulation of public utilities has become a worldwide phenomenon with the preceding privatisation stream. It is questionable to transfer regulatory models hastily without customising the policy options or introducing necessary institutional reforms enabling the achievement of expected results of regulatory reform. Institutional configuration of a country affects credibility of regulatory commitments, quality of regulatory design, and way of policy transfer. Turkey’s energy market regulation experience confirms the decisive role of institutions in shaping the regulatory framework. - Highlights: ► The last quarter of the 20th century witnessed public sector reforms all over the world. ► The British model of utility regulation swept globally. ► In Turkey’s adoption of the utility regulation model, different factors affected in various ways. ► Higher political stability and regulatory experience provide faith in the regulatory framework.

Farmers’ Markets: Positive Feelings of Instagram Posts

Directory of Open Access Journals (Sweden)

Ladislav Pilař

2016-01-01

Full Text Available With increasing consumer requirements, farmers and vendors see the importance of social media as a marketing tool to engage with consumers. In particular, on a more personal level for reasons of brand management. Instagram is becoming increasingly popular as a marketing communication tool. The aim of this paper is to identify areas that users evaluate in terms of positive feelings in connection with farmers’ markets. The results are based on the analysis of the worldwide, and Czech, instagram social network. Instagram posts were identified on the basis of keywords, such as #farmarsketrhy and #farmersmarkets. The results of the study are based on 100,000 contributions on Instagram made by 55,632 users. The analysis contains 1,357,812 ‘unique’ words. The results identified six major areas (1 Healthy (2 Good (3 Great (4 Happy (5 Nice (6 Perfect. An appropriately posted hashtag indicated the positive feelings that were evoked and then assigned to a matching category. The research results are used to identify group characteristics that exert these positive feelings while visiting farmers’ markets. These results can be used to build communications campaigns for farmers’ markets. They can also be used as a basis for further research in defining the behaviour of farmers’ markets visitors, based on cultural differences arising from geographic location.

Do regulatory mechanisms promote competition and mitigate market power? Evidence from Spanish electricity market

International Nuclear Information System (INIS)

Moutinho, Victor; Moreira, António C.; Mota, Jorge

2014-01-01

This paper estimates the relationships between bidding quantities, marginal cost and market power measures in the Spanish wholesale electricity market for two different regulatory periods: 2002–2005 and 2006–2007. Using panel econometric techniques we find differences in the impacts on bidding strategies for both periods. Hence, the marginal cost and the market power measures affect bid and net quantities. The market power measures also suggest that the coefficient is consistently positive and highly significant for both periods. Moreover, the market power and marginal costs have mixed effects according to the models proposed for both periods. In addition, our results point to the effectiveness of the different effects of mitigating the market power in the Spanish electricity market. For the 2006–2007 period, the proposed causal relationships are partially validated by the cointegration results, which assumes there is a significant causality between the Lerner Index and the marginal cost. - Highlights: • Competition and regulation in the Spanish electricity market. • Net supplier and net demander behavior in the spot market. • Panel cointegration methods used: FMOLS, PMG, MG, DFE and DOLS. • The price cap regulation is effective in mitigating market power. • Market power and marginal cost have positive effects on bidding strategies

Mapping out the regulatory environment and its interaction with land and property markets

International Nuclear Information System (INIS)

Adams, David

2008-01-01

The purpose of this paper is to explain how the regulatory environment created by planning and building regulations interacts with land and property markets. Since this regulatory environment operates as a form of intervention within property markets in general and the development process in particular, it is essential first to understand the nature, structure and operation of land and property markets. These are covered in the first section. The second section identifies the aims and components of the planning system and building regulations. From this basis, four broad types of policy intervention are reviewed in the third section. These cover policies that seek to shape, regulate or stimulate market activity, and those that aim to build state or market capacity to produce desired outcomes. The final section uses the private residential development process as a case study to explore the extent to which state intervention can influence producer-consumer relationships in one important market sector. The paper argues that effective intervention in land and property markets requires the creation of a broad range of policy tools and their appropriate deployment to suit particular market circumstances. (author)

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

Science.gov (United States)

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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

Pediatric post-marketing safety systems in North America: assessment of the current status.

Science.gov (United States)

McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

2015-08-01

It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

Preferred supplier contracts in post-patent prescription drug markets.

Science.gov (United States)

Blankart, Carl Rudolf; Stargardt, Tom

2016-02-22

In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

[Thought on several problems of clinical revaluation of post-marketing herb research].

Science.gov (United States)

He, Wei; Xie, Yanming; Wang, Yongyan

2010-06-01

The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

A Process Perspective on Regulation: A Grounded Theory Study into Regulatory Practice in Newly Liberalized Network-Based Markets

NARCIS (Netherlands)

Ubacht, J.

The transition from a former monopolistic towards a more competitive market in
newly liberalized network-based markets raises regulatory issues. National Regulatory Authorities (NRA) face the challenge to deal with these issues in order to guide the transition process. Although this transition

Regulatory theory: commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods.

Science.gov (United States)

Warren-Jones, Amanda

2017-10-01

Regulatory theory is premised on the failure of markets, prompting a focus on regulators and industry from economic perspectives. This article argues that overlooking the public interest in the sustainability of commercial markets risks markets failing completely. This point is exemplified through health care markets - meeting an essential need - and focuses upon innovative medicines as the most desired products in that market. If this seemingly invulnerable market risks failure, there is a pressing need to consider the public interest in sustainable markets within regulatory literature and practice. Innovative medicines are credence goods, meaning that the sustainability of the market fundamentally relies upon the public trusting regulators to vouch for product quality. Yet, quality is being eroded by patent bodies focused on economic benefits from market growth, rather than ensuring innovatory value. Remunerative bodies are not funding medicines relative to market value, and market authorisation bodies are not vouching for robust safety standards or confining market entry to products for 'unmet medical need'. Arguably, this failure to assure quality heightens the risk of the market failing where it cannot be substituted by the reputation or credibility of providers of goods and/or information such as health care professionals/institutions, patient groups or industry.

76 FR 3188 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-01-19

...-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Routing Fees for the NASDAQ Options Market January 12, 2011. Pursuant to... is hereby given that on January 6, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

76 FR 78325 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-12-16

...-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a Proposed... November 30, 2011. The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to amend Rule 7056 entitled ``NASDAQ Options Fee Disputes...

Market power versus regulatory power in the Spanish electricity system, 1973-1996

International Nuclear Information System (INIS)

Garrues-Irurzun, Josean

2010-01-01

This study not only establishes that the institutional changes (the change of political regime) and economic changes (the energy crisis) that occurred during the 70s and 80s had an important effect on business strategies within the Spanish electricity sector, but, above all, it shows how the resulting regulatory model was not the product of any clearly defined plan on the part of the Spanish authorities (as the majority of authors seem to implicitly or explicitly maintain), but rather it arose from the dialectical interaction between companies which resisted losing the power of the market, and institutions which, in order to define any medium term energy policy in the future European domestic electricity market, required an increase in their regulatory power. (author)

76 FR 48186 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-08-08

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that, on July 27, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ... NASDAQ Stock Market and the NASDAQ Options Market. Currently, a member that provides shares of liquidity...

Directory of Post-Secondary Retailing and Marketing Vocational Programs.

Science.gov (United States)

American Vocational Association, Inc., Washington, DC.

This directory lists 357 general and 135 special retailing and marketing vocational programs at the post secondary level. Institutions vary somewhat in the identification of general programs; for example, they may be called retailing, merchandising, marketing, mid-management, or distributive education programs. Specialized programs offered by…

75 FR 78789 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-12-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on December 9, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange... market and a national market system, and, in general, to protect investors and the public interest. The...

75 FR 10541 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-03-08

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on February 24, 2010, The NASDAQ Stock Market LLC (``Nasdaq'') filed with the... impediments to and perfect the mechanism of a free and open market and a national market system, and, in...

Market Power in Power Markets: Evidence from Forward Prices of Electricity

DEFF Research Database (Denmark)

Christensen, Bent Jesper; Jensen, Thomas Elgaard; Mølgaard, Rune

We examine the forward market for electricity for indications of misuse of market power, using a unique data set on OTC price indications posted by Elsam A/S, the dominant producer in Western Denmark, which is one of the price areas under the Nordic power exchange Nord Pool. The Danish Competition...... Council (the regulatory government agency) has ruled that Elsam has used its dominant position to obtain excessive spot prices over a period from July 2003 through December 2006. We show that significant forward premia exist, and that they are related both to spot market volatility and misuse of market...... are consistent across forward premium regressions and structural forward pricing models....

[Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

Science.gov (United States)

Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

2013-09-01

Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

Science.gov (United States)

Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

2016-05-01

Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

76 FR 55988 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-09-09

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...,\\2\\ notice is hereby given that, on August 31, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or... perfect the mechanism of a free and open market and a national market system, and, in general to protect...

77 FR 4610 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-01-30

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on January 11, 2012, The NASDAQ Stock Market LLC (``Nasdaq'') filed with the Securities... impediments to and perfect the mechanism of a free and open market and a national market system, and, in...

75 FR 43591 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-07-26

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on June 30, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with the... mechanism of a free and open market and a national market system, and, in general, to protect investors and...

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.

Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence.

Science.gov (United States)

Trifirò, Gianluca; Marcianò, Ilaria; Ingrasciotta, Ylenia

2018-03-01

Since 2006, biosimilars have been available in several countries worldwide, thus allowing for potential savings in pharmaceutical expenditure. However, there have been numerous debates about the interchangeability of biosimilars and reference products based on concerns of immunogenicity by switching between biological products, which may cause lack of effect and toxicity. Areas covered: The authors provide the reader with an overview of the different positions of regulatory authorities on the interchangeability and automatic substitution of biosimilars and reference products. Presently, the FDA allows automatic substitution without prescriber intervention if the biosimilar is interchangeable with reference products, while the European Medicines Agency delegate to each single EU member state. Expert opinion: Different approaches in defining interchangeability and automatic substitution call for harmonization to increase confidence of healthcare professionals and patients about the clinical impact of switching. Networks of electronic healthcare records and administrative databases, potentially linkable to clinical charts and registries may rapidly assess frequency and benefit-risk profile of different switching patterns in routine care at different levels, thus integrating and strengthening pre-marketing evidence.

Regulatory environment and its impact on the market value of investor-owned electric utilities

Science.gov (United States)

Vishwanathan, Raman

While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

76 FR 40971 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-07-12

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... June 27, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities... NASDAQ Options Market (``NOM'') to amend Chapter VI, Trading Systems, Section 11, Order Routing, to...

76 FR 34783 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-06-14

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...,\\2\\ notice is hereby given that on May 26, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or... telecommunication, inter-cabinet connectivity, connectivity to NASDAQ and market data connectivity related to an...

78 FR 68122 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-11-13

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 28, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed... Section 2 governing pricing for NASDAQ members using the NASDAQ Options Market (``NOM''), NASDAQ's...

76 FR 44076 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-07-22

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NASDAQ Stock Market Equities Trading Rules 4757 and 4758 and NASDAQ Options... NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities and Exchange...

75 FR 6077 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-02-05

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on January 29, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with... markets. Such assessments consider factors such as a destination's latency, fill rates, reliability, and...

78 FR 28912 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-05-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on April 30, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange... ``Options Pricing,'' at Section 2 governing pricing for NASDAQ members using the NASDAQ Options Market...

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.

77 FR 52373 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-08-29

...-Regulatory Organizations; NASDAQ Stock Market, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Membership in The NASDAQ Stock Market LLC August 23, 2012. Pursuant to Section... is hereby given that on August [[Page 52374

77 FR 48570 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2012-08-14

... Underlying Securities) of the NASDAQ Options Market rules.\\11\\ Additionally, the Target Component's and the...\\ Additionally, the Target Component's and the Benchmark Component's trading volume (in all markets in which the...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to the...

77 FR 15163 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-03-14

... troubling trend of reduced participation in the equity markets by individual investors, and that nearly 30... different asset classes within a single strategy. NASDAQ also notes that cash equities and options markets...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

75 FR 9632 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-03-03

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Pricing for the NASDAQ Options Market (``NOM'') February 24, 2010. Pursuant... thereunder,\\2\\ notice is hereby given that, on January 27, 2010, The NASDAQ Stock Market LLC (``NASDAQ...

76 FR 46869 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-08-03

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... that, on July 22, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the...'') a proposal for the NASDAQ Options Market (``NOM'') to amend Chapter VI, Trading Systems, Section 1...

77 FR 10794 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-02-23

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... February 13, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to modify Chapter XV, Section 2, governing pricing for NASDAQ...

77 FR 19044 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-03-29

...-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange... halt, there is a 15-minute Display-Only Period during which market participants may enter quotes and...

78 FR 71018 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-11-27

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on November 8, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed... service. This new low latency service decreases the time individual orders are processed and market data...

76 FR 71088 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-11-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... November 1, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to create a new Rule 7056 entitled ``NASDAQ Options Fee...

78 FR 31616 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-05-24

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and... shall include: (1)-(14) No change. (15) ``Market Maker Peg Order'' is a limit order that, upon entry...

78 FR 27466 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-05-10

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a..., 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange... for which the Exchange is the listing market, the System shall determine whether a transaction in a...

78 FR 49308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-08-13

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on July 25, 2013 The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with... market data is transmitted by these new switches. The Exchange's proposal provides the co-located client...

78 FR 3480 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-01-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on January 4, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange... historical latency of the member firm's order messages sent to and from the NASDAQ Market Center (``System...

76 FR 48189 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-08-08

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on July 26, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and... Nasdaq for connectivity to systems operated by NASDAQ, including the Nasdaq Market Center, the FINRA...

77 FR 27256 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-05-09

... \\21\\ routing strategy but that execute in the Nasdaq Market Center. Accordingly, such orders will be...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on April 25, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the...

Timing Is everything: quantifying regulatory and market readiness levels for technology transition policy analysis

Energy Technology Data Exchange (ETDEWEB)

Kobos, Peter Holmes [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Malczynski, Leonard A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Walker, La Tonya Nicole [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Borns, David James [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

2014-03-01

People save for retirement throughout their career because it is virtually impossible to save all you’ll need in retirement the year before you retire. Similarly, without installing incremental amounts of clean fossil, renewable or transformative energy technologies throughout the coming decades, a radical and immediate change will be near impossible the year before a policy goal is set to be in place. This notion of steady installation growth over acute installations of technology to meet policy goals is the core topic of discussion for this research. This research operationalizes this notion by developing the theoretical underpinnings of regulatory and market acceptance delays by building upon the common Technology Readiness Level (TRL) framework and offers two new additions to the research community. The new and novel Regulatory Readiness Level (RRL) and Market Readiness Level (MRL) frameworks were developed. These components, collectively called the Technology, Regulatory and Market (TRM) readiness level framework allow one to build new constraints into existing Integrated Assessment Models (IAMs) to address research questions such as, ‘To meet our desired technical and policy goals, what are the factors that affect the rate we must install technology to achieve these goals in the coming decades?’

[Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

Science.gov (United States)

Fu, Yingkun; Xie, Yanming

2011-10-01

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

77 FR 21823 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-04-11

... Commission Chairman on what she viewed as a troubling trend of reduced participation in the equity markets by... investment strategy. NASDAQ also notes that cash equities and options markets are linked, with liquidity and...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

75 FR 12318 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-03-15

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Pricing for Option Orders Routed to Away Markets March 5, 2010. Pursuant...,\\2\\ notice is hereby given that on March 2, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or...

75 FR 21069 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-04-22

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center April 16, 2010. Pursuant to... is hereby given that on April 13, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

76 FR 12178 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-03-04

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Offer Market Data to the Public at No Charge February 25, 2011. Pursuant to Section... hereby given that, on February 24, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

75 FR 18932 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-04-13

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center April 6, 2010. Pursuant to... is hereby given that on March 30, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

75 FR 29596 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-05-26

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center May 19, 2010. Pursuant to... is hereby given that on May 14, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

77 FR 1542 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-01-10

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center January 4, 2012. Pursuant to... is hereby given that on December 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

75 FR 57091 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-09-17

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center September 10, 2010. Pursuant...\\ notice is hereby given that on September 7, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

75 FR 77034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-12-10

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., notice is hereby given that on December 3, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange...) Pricing Obligations. For NMS stocks (as defined in Rule 600 under Regulation NMS) a Market Maker shall...

75 FR 33878 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-06-15

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Modify Fees for Members Using the NASDAQ Market Center June 9, 2010. Pursuant to... is hereby given that on June 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

76 FR 35930 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-06-20

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Market Order Spread Protection Feature June 14, 2011. Pursuant to Section... hereby given that on June 8, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed...

76 FR 50521 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-08-15

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding a Clerical Change to NASDAQ Options Market Rules August 9, 2011. Pursuant to... is hereby given that on August 2, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

75 FR 63238 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-10-14

... availability of the credit to only DLPs providing displayed liquidity through the Nasdaq Market Center. A... market in ETFs and ILSs. As currently written, however, Rule 7018(i) provides a credit for any type of...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

78 FR 29193 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-05-17

... actively in the NASDAQ Market Center justifiably earn the higher credit of $0.0005 per share executed. This...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Remove Pilot Restrictions From NASDAQ's Qualified Market Maker and NBBO Setter...

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

Science.gov (United States)

Sanders, M E; Huis in't Veld, J

1999-01-01

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

Progressing towards post-2012 carbon markets

Energy Technology Data Exchange (ETDEWEB)

Soeren Luetken, S.; Holm Olsen, K.

2011-11-15

Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

Progressing towards post-2012 carbon markets

Energy Technology Data Exchange (ETDEWEB)

Soeren Luetken, S; Holm Olsen, K

2011-11-15

Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

Global regulatory framework for production and marketing of crops biofortified with vitamins and minerals.

Science.gov (United States)

Mejia, Luis A; Dary, Omar; Boukerdenna, Hala

2017-02-01

Biofortification of crops is being introduced in several countries as a strategy to reduce micronutrient deficiencies. Biofortified products, with increased contents of micronutrients, are currently produced by conventional plant breeding, genetic modification, or nutrient-enhanced fertilization. Corn, rice, wheat, beans, pearl millet, sweet potato, and cassava have been biofortified with increased contents of provitamin A carotenoids, iron, or zinc. However, regulatory considerations are rare or nonexistent. The objective of this paper is to review the regulatory framework for production and marketing of biofortified crops in countries that have adopted this strategy. The information was identified using Internet search engines and websites of health and nutrition organizations and nongovernmental organizations and by consulting scientists and government authorities. Thus far, biofortified products introduced in Latin America, Africa, and Asia have been produced only by conventional breeding. Cultivars using other techniques are still under testing. The production and marketing of these products have been conducted without regulatory framework and under limited government control or regulatory guidance. Nevertheless, some countries have integrated biofortified crops into their nutrition agendas. Although improvements by conventional breeding have not been subject to regulations, when biofortification becomes expanded by including other techniques, an appropriate regulatory framework will be necessary. © 2016 New York Academy of Sciences.

76 FR 27699 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-05-12

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on April 28, 2011 The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the... inside market and the midpoint for stocks at this price level is likely to be extremely small, and...

75 FR 77022 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-12-10

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on November 24, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange..., assesses fees for its real time market data. In general, a customer that receives a data feed directly from...

77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2012-08-08

... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

78 FR 17272 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-03-20

... the locking or crossing market center. LIST is a routing strategy that is used by firms that wish for...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... March 1, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and...

78 FR 49578 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-08-14

... market center. LIST is a routing strategy that is used by firms that wish for their orders to participate...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... hereby given that on August 5, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with...

78 FR 3928 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Disapproving Proposed Rule...

Science.gov (United States)

2013-01-17

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Disapproving Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) January 11, 2013. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange Commission...

Regulatory design for RES-E support mechanisms: Learning curves, market structure, and burden-sharing

International Nuclear Information System (INIS)

Batlle, C.; Pérez-Arriaga, I.J.; Zambrano-Barragán, P.

2012-01-01

Drawing from relevant experiences in power systems around the world, this paper offers a review of existing policy support mechanisms for RES-E, with a detailed analysis of their regulatory implications. While recent studies provide an account of current RES-E support systems, in this paper we focus on some of the impacts these mechanisms have on the overall energy market structure and its performance. Given the rising importance of RES-E in systems everywhere, these impacts should no longer be overlooked. - Highlights: ► This paper offers a critical review of RES-E support mechanisms and their regulatory implications. ► The discussion focuses on how the different schemes impact the performance of the energy markets. ► We propose to redesign of current RES-E mechanisms to optimize incentives and market performance. ► Our recommendation is also to gradually move from price-based mechanisms to auctions.

77 FR 50191 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

Science.gov (United States)

2012-08-20

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) August 14, 2012. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

Regulatory affairs for biomaterials and medical devices

CERN Document Server

Amato, Stephen F; Amato, B

2015-01-01

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co

[Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

Science.gov (United States)

Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

2011-10-01

In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

77 FR 22042 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2012-04-12

... provide information regarding, for example, volume metrics, number of MQP Market Makers in target...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Establish the Market Quality Program April 6, 2012. Pursuant to...

Post-neoliberal electricity market 're-reforms' in Argentina. Diverging from market prescriptions?

International Nuclear Information System (INIS)

Haselip, James; Potter, Clive

2010-01-01

This paper focuses upon the policy and institutional change that has taken place within the Argentine electricity market since the country's economic and social crisis of 2001/2. As one of the first less developed countries (LDCs) to liberalise and privatise its electricity industry, Argentina has since moved away from the orthodox market model after consumer prices were frozen by the Government in early 2002 when the national currency was devalued by 70%. Although its reforms were widely praised during the 1990s, the electricity market has undergone a number of interventions, ostensibly to keep consumer prices low and to avert the much-discussed energy 'crisis' caused by a dearth of new investment combined with rising demand levels. This paper explores how the economic crisis and its consequences have both enabled and legitimised these policy and institutional amendments, while drawing upon the specifics of the post-neoliberal market 're-reforms' to consider the extent to which the Government appears to be moving away from market-based prescriptions. In addition, this paper contributes to sector-specific understandings of how, despite these changes, neoliberal ideas and assumptions continue to dominate Argentine public policy well beyond the postcrisis era. (author)

78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2013-10-22

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2012-10-25

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

Regulatory assessment of brand changes in the commercial tobacco product market.

Science.gov (United States)

Wayne, G Ferris; Connolly, G N

2009-08-01

Regulatory oversight of tobacco product design has gained momentum in the US and internationally. Appropriate standards for assessing commercial brands and characterising product features must be considered a priority. An area of potential concern is in-market design changes adopted within a single commercial brand over time. Internal tobacco industry documents were identified and used to assess internal discussion of product guidelines and practices regarding in-market brand changes. Commercial tobacco products undergo a constant process of revision in-market, beginning at the most basic level of physical product characteristics and components, and including every aspect of design. These revisions commonly exceed guidelines for acceptable product variance adopted within the industry. While consumer and market testing is conducted to ensure that products remain acceptable to users, explicit marketing often may not accompany brand changes. In the absence of such marketing, it should not be assumed that a brand remains unchanged. For manufacturers, assessment of competitor brands includes identification and analysis of non-routine changes; that is, those changes likely to significantly alter the character of a given brand. Regulators must adopt a similar practice in determining standards for product evaluation in the face of ongoing commercial product revision.

Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.

Science.gov (United States)

Nijhara, Ruchika; Balakrishnan, Krishna

2006-06-01

Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

Post-Project Market Review as a Tool for Stimulating Commercialisation of Knowledge Creation Projects

NARCIS (Netherlands)

Bout, Y.; Lombaers, Jaap H.M.; Constantinides, Efthymios; Fisscher, O.A.M.; de Weerd-Nederhof, Petronella C.; Oakey, R.; Groen, A.; Cook, G.; van der Sijde, P.

2009-01-01

Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, post-project reviews can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von Zedtwitz,

Post-project market review as a tool for stimulating commercialisation of knowledge creation projects

NARCIS (Netherlands)

Bout, L.Y.; Lombaers, J.H.M.; Constantinides, E.; Weerd-Nederhof, P.C. de

2009-01-01

Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, the concept of post-project review can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von

75 FR 63229 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-10-14

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed... has received approval to launch NASDAQ OMX PSX (``PSX'') \\3\\ as a new platform for trading NMS stocks...

76 FR 65306 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-10-20

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 6, 2011, the NASDAQ Stock Market, LLC (``NASDAQ'' or ``Exchange'') filed... experience a significant percentage price increase or decline. Once a stock is halted pursuant to the rule, a...

77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

Science.gov (United States)

2012-08-15

... entering new orders at inferior prices. This occurs because the current process directs the order to NASDAQ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule... June 14, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed with the Securities and...

76 FR 2732 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer...

Science.gov (United States)

2011-01-14

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer Period for Commission.... Introduction On June 18, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with the... change. The Commission may extend the period for issuing an order approving or disapproving the proposed...

76 FR 77032 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-12-09

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify NASDAQ's Transaction Execution Fee and Credit Schedule in Rule 7018 December... 19b-4 thereunder,\\2\\ notice is hereby given that on November 30, 2011, The NASDAQ Stock Market LLC...

76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

Science.gov (United States)

2011-04-14

...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

The Price and Volatility Dynamics in the Swedish-Norwegian Renewable Electricity Certificate MarketA Study of Spillover Effects and Regulatory changes

OpenAIRE

Finell, Philip; Hiller, Maria

2016-01-01

The market for renewable electricity certificates (REC) is the primary support system for renewable energy in Sweden and Norway. Regulatory uncertainty and equity markets have previously been proven to impact the volatility of the REC spot contract. As policy makers, renewable electricity investors and other stakeholders aim for profitability and efficient regulation, additional insights of the dynamics in the  REC market is needed. This study examines regulatory uncertainty on both REC spot ...

75 FR 69502 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-11-12

... structure and assess a flat fee of $300 per test port, per month for all but CTCI and FIX connections to ACT...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of the Substance of the Proposed...

Localizing potentially active post-transcriptional regulations in the Ewing's sarcoma gene regulatory network

Directory of Open Access Journals (Sweden)

Delyon Bernard

2010-11-01

Full Text Available Abstract Background A wide range of techniques is now available for analyzing regulatory networks. Nonetheless, most of these techniques fail to interpret large-scale transcriptional data at the post-translational level. Results We address the question of using large-scale transcriptomic observation of a system perturbation to analyze a regulatory network which contained several types of interactions - transcriptional and post-translational. Our method consisted of post-processing the outputs of an open-source tool named BioQuali - an automatic constraint-based analysis mimicking biologist's local reasoning on a large scale. The post-processing relied on differences in the behavior of the transcriptional and post-translational levels in the network. As a case study, we analyzed a network representation of the genes and proteins controlled by an oncogene in the context of Ewing's sarcoma. The analysis allowed us to pinpoint active interactions specific to this cancer. We also identified the parts of the network which were incomplete and should be submitted for further investigation. Conclusions The proposed approach is effective for the qualitative analysis of cancer networks. It allows the integrative use of experimental data of various types in order to identify the specific information that should be considered a priority in the initial - and possibly very large - experimental dataset. Iteratively, new dataset can be introduced into the analysis to improve the network representation and make it more specific.

77 FR 68873 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer...

Science.gov (United States)

2012-11-16

... ``Benchmark Orders'' Under NASDAQ Rule 4751(f) November 9, 2012. On May 1, 2012, The NASDAQ Stock Market LLC...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer Period for Commission... proposed rule change to establish various ``Benchmark Orders'' under NASDAQ Rule 4751(f). The proposed rule...

76 FR 48193 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-08-08

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule To Amend Fees Assessed for Use of NASDAQ Pre-Trade Risk Management August 3, 2011. Pursuant...\\ notice is hereby given that, on July 25, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

[Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

Science.gov (United States)

Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

2011-10-01

The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

Considering the post-1995 enrichment market

International Nuclear Information System (INIS)

Gunter, L.

1994-01-01

World demand for uranium enrichment services is likely to grow only a little over the next decade, from the current 28 million separative work units (SWU) per year to 33 MSWU per year. Much of the growth will come from Asia where nuclear generating capacity is still increasing. The current situation of the primary enrichment companies is summarized. The primary Western suppliers, Cogema, United States Enrichment Corporation and Urenco, are competing for increased market share in the USA, Europe and Asia as utilities purchase their post-1995 requirements. Entry of the Russian enrichment company, Tenex, into Western markets has been limited by trade restrictions. As a consequence of disarmament, blended weapons material has resulted in a surplus of low-enriched uranium. Together with over-capacity amongst the primary enrichers this has led to an expectation that reduced prices will be negotiable in the medium term. (3 figures). (UK)

76 FR 64142 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2011-10-17

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change Regarding... September 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and Exchange... closely tailor their investment and risk management strategies and decisions. Furthermore, the Exchange...

78 FR 36801 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-06-19

... market quality by allowing it to set or join the NBBO, the NBBO Setter Incentive credit would be paid...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... Credits June 13, 2013. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\\1...

A theory of planning horizons (1: market design in a post-neoclassical world

Directory of Open Access Journals (Sweden)

Frederic B. Jennings, Jr.

2012-05-01

Full Text Available The neoclassical case supporting competitive frames and market solutions has failed to promote stable world-wide economic development. Other approaches in economics incorporate social culture, increasing returns, market power, ecological limits and complementarity, yielding broader applications for development theory. In this paper a theory of planning horizons is introduced to raise some meaningful questions about the traditional view with respect to its substitution, decreasing returns and independence assumptions. Suppositions of complementarity, increasing returns and interdependence suggest that competition is inefficient by upholding a myopic culture resistant to learning. Growth – though long believed to rise from markets and competitive values – may not derive from these sources. Instead, as civilizations advance, shifting from material wants to higher-order intangible output, they evolve from market tradeoffs (substitution and scarcity into realms of common need (complementarity and abundance. The policy implications of horizonal theory are explored, with respect to regulatory aims and economic concerns. Such an approach emphasizes strict constraints against entry barriers, ecological harm, market power abuse and ethical lapses. Social cohesion – not competition – is sought as a means to extend horizons and thereby increase efficiency, equity and ecological health. The overriding importance of horizon effects for regulatory assessment dominates other orthodox standards in economics and law. Reframing economics along horizonal lines suggests some meaningful insight on the proper design of economic systems.

[Post-marketing drug safety-risk management plan(RMP)].

Science.gov (United States)

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

Depressive symptoms, post-traumatic stress symptoms and suicide risk among graduate students: The mediating influence of emotional regulatory self-efficacy.

Science.gov (United States)

Zeng, Baoer; Zhao, Jiubo; Zou, Laiquan; Yang, Xueling; Zhang, Xiaoyuan; Wang, Wanjun; Zhao, Jingbo; Chen, Jie

2018-06-01

The current study was to examine the relationship among depressive symptoms, post-traumatic stress symptoms, emotion regulatory self-efficacy and suicide risk. A cross-sectional survey was conducted among 3257 graduate students from a medical college of China. Lifetime prevalence of suicidal ideation, plan and attempt were 25.7%, 1.6%, 1.1%, respectively, with one-year suicidal ideation showing at 6.3%. Structural equation modeling was employed to examine the relative contribution of depressive symptoms, post-traumatic stress symptoms and emotion regulatory self-efficacy on suicide risk. Structural equation model had a highly satisfactory fit [χ 2  = 7.782, df = 4, p = 0.096; RMSEA = 0.021; CFI = 0.992; GFI = 0.997]. Post-traumatic stress symptoms had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. Depressive symptoms also had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. The depressive and post-traumatic stress symptoms increased the risk of suicide risk, but the variable of emotion regulatory self-efficacy would be served as a buffering factor, decreasing the risk of suicide. The interaction term of depressive symptoms and post-traumatic stress symptoms had a direct effect on suicide risk. A significant interactive effect of depressive and post-traumatic stress symptoms on suicide risk was found. Copyright © 2018 Elsevier B.V. All rights reserved.

Subcontracting, Posted Migrants and Labour Market Segmentation in Finland

NARCIS (Netherlands)

Lillie, Nathan

Using evidence from the shipbuilding and construction industries in Finland, this article shows how trade union responses to the introduction of migrant workers can be conditioned by product markets. Growing numbers of posted workers, or intra-European Union work migrants employed via transnational

Enforcing Margin Squeeze Ex Post Across Converging Telecommunications Markets

DEFF Research Database (Denmark)

Bergqvist, Christian; Townsend, John

, delay profitability or limit their ability to remain or expand on markets. However, traditional market definitions are being challenged by (1) the technological convergence of services and (2) innovative product offerings taking advantage of this convergence. Consumers now routinely purchase a bundle...... and innovation present both theoretical and practical difficulties for assessing “muddled margins” on telecoms markets. New and different enforcement approaches to exclusion will have to be formulated within the Article 102 framework and tested in the Courts. This may even require abstaining from applying...... Article 102 TFEU during material periods of convergence, and confining ex post enforcement activity to sector regulation, even when this is inferior for safeguarding effective competition....

Clinical trials in "emerging markets": regulatory considerations and other factors.

Science.gov (United States)

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

78 FR 69468 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and...

Science.gov (United States)

2013-11-19

... provide that in situations of a regulatory halt, trading pause or market-wide trading halt, a Post-Halt... situation of a halt pursuant to Rule 504(a), just as today, the Post-Halt Notification will continue to be..., Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. All submissions should refer...

77 FR 39314 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer...

Science.gov (United States)

2012-07-02

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) June 26, 2012. On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the...

76 FR 34281 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2011-06-13

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Adopt a Risk Monitor Mechanism June 7, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of... NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and Exchange Commission (``Commission...

Towards a single European electricity market : A structured approach to regulatory mode decision-making

NARCIS (Netherlands)

De Jong, H.M.

2009-01-01

This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory

78 FR 75619 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2013-12-12

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend the...\\ notice is hereby given that on November 27, 2013, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange... to vote generally in the election of directors (the ``Voting Stock''), voting together as a single...

Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

Science.gov (United States)

Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

2006-10-01

The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

Science.gov (United States)

Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

2014-09-01

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

75 FR 9985 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2010-03-04

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend the... February 24, 2010, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities... of the votes at any election of directors at which a quorum is present is duly elected to the Board...

78 FR 50123 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

Science.gov (United States)

2013-08-16

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule Change to Assume... NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and Exchange...: Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

Correct fair market value calculation needed to avoid regulatory challenges.

Science.gov (United States)

Dietrich, M O

1997-09-01

In valuing a physician practice for acquisition, it is important for buyers and sellers to distinguish between fair market value and strategic value. Although many buyers would willingly pay for the strategic value of a practice, tax-exempt buyers are required by law to consider only the fair market value in setting a bid price. Valuators must adjust group earnings to exclude items that do not apply to any willing seller and include items that do apply to any willing seller to arrive at the fair market value of the practice. In addition, the weighted average cost of capital (WACC), which becomes the discount rate in the valuation model, is critical to the measure of value of the practice. Small medical practices are assumed to have few hard assets and little long-term debt, and the WACC is calculated on the basis of those assumptions. When a small practice has considerable debt, however, this calculated WACC may be inappropriate for valuing the practice. In every case, evidence that shows that a transaction has been negotiated "at arm's length" should stave off any regulatory challenge.

75 FR 60844 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Order Granting...

Science.gov (United States)

2010-10-01

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Order Granting Accelerated... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 14, 2010, The NASDAQ Stock Market... voting on the election of a member of the board of directors of an issuer (except for a vote with respect...

Post-crisis asymmetries of the world market development of banking services

Directory of Open Access Journals (Sweden)

Vladyslav Тіpanov

2011-09-01

Full Text Available In the article there were analyzed theoretical backgrounds for defining the concept «banking service» by scientists from different countries: considered its main characteristics and classification, determined the key peculiarities of the world market functioning of banking services and its structure, found out the present-day developments of the world market of banking services under conditions of post-crisis period.

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

Science.gov (United States)

Silva, Ivair R

2018-01-15

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

Directory of Open Access Journals (Sweden)

Ran Tian

2017-10-01

Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

77 FR 24549 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 1...

Science.gov (United States)

2012-04-24

.... Further, to address concerns about the potential manipulation of lower priced stocks to meet the initial...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 1 and Order Granting..., 2012. I. Introduction On January 3, 2012, The NASDAQ Stock Market LLC (``Exchange'' or ``Nasdaq...

Cosmetic Surgery: Regulatory Challenges in a Global Beauty Market.

Science.gov (United States)

Griffiths, Danielle; Mullock, Alex

2017-02-28

The market for cosmetic surgery tourism is growing with an increase in people travelling abroad for cosmetic surgery. While the reasons for seeking cosmetic surgery abroad may vary the most common reason is financial, but does cheaper surgery abroad carry greater risks? We explore the risks of poorly regulated cosmetic surgery to society generally before discussing how harm might be magnified in the context of cosmetic tourism, where the demand for cheaper surgery drives the market and makes surgery accessible for increasing numbers of people. This contributes to the normalisation of surgical enhancement, creating unhealthy cultural pressure to undergo invasive and risky procedures in the name of beauty. In addressing the harms of poorly regulated surgery, a number of organisations purport to provide a register of safe and ethical plastic surgeons, yet this arguably achieves little and in the absence of improved regulation the risks are likely to grow as the global market expands to meet demand. While the evidence suggests that global regulation is needed, the paper concludes that since a global regulatory response is unlikely, more robust domestic regulation may be the best approach. While domestic regulation may increase the drive towards foreign providers it may also have a symbolic effect which will reduce this drive by making people more aware of the dangers of surgery, both to society and individual physical wellbeing.

The influence of regulatory fit and interactivity on brand satisfaction and trust in E-health marketing inside 3D virtual worlds (Second Life).

Science.gov (United States)

Jin, Seung-A Annie; Lee, Kwan Min

2010-12-01

Interactive three-dimensional (3D) virtual environments like Second Life have great potential as venues for effective e-health marketing and e-brand management. Drawing from regulatory focus and interactivity literatures, this study examined the effects of the regulatory fit that consumers experience in interactive e-health marketing on their brand satisfaction and brand trust. The results of a two-group comparison experiment conducted within Second Life revealed that consumers in the regulatory fit condition show greater brand satisfaction and brand trust than those in the regulatory misfit condition, thus confirming the persuasive influence of regulatory fit in e-brand management inside 3D virtual worlds. In addition, a structural equation modeling analysis demonstrated the mediating role of consumers' perceived interactivity in explaining the processional link between regulatory fit and brand evaluation. Theoretical contributions and managerial implications of these findings are discussed.

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

Science.gov (United States)

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

Risk management and post-marketing surveillance of CNS drugs.

Science.gov (United States)

Henningfield, Jack E; Schuster, Charles R

2009-12-01

Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

78 FR 70388 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-11-25

... [bracketed]. New text is italicized. NASDAQ Stock Market Rules Options Rules * * * * * Chapter VI Trading... the need for Market Makers to cancel and re-enter orders depending on time of opening. \\10\\ Chapter VI..., and the CSCO calls open on the Exchange. The Market Maker will now need to mark new bids as Post-Only...

Everyday, everywhere: alcohol marketing and social media--current trends.

Science.gov (United States)

Nicholls, James

2012-01-01

To provide a snapshot content analysis of social media marketing among leading alcohol brands in the UK, and to outline the implications for both regulatory policies and further research. Using screengrab technology, the complete Facebook walls and Twitter timelines for 12 leading UK alcohol brands in November 2011 were captured and archived. A total of 701 brand-authored posts were identified and categorized using a thematic coding frame. Key strategic trends were identified and analysed in the light of contextual research into recent developments in marketing practice within the alcohol industry. A number of dominating trends were identified. These included the use of real-world tie-ins, interactive games, competitions and time-specific suggestions to drink. These methods reflect a strategy of branded conversation-stimulus which is favoured by social media marketing agencies. A number of distinct marketing methods are deployed by alcohol brands when using social media. These may undermine policies which seek to change social norms around drinking, especially the normalization of daily consumption. Social media marketing also raises questions regarding the efficacy of reactive regulatory frameworks. Further research into both the nature and impact of alcohol marketing on social media is needed.

Regulation – Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

Directory of Open Access Journals (Sweden)

Clare O'Dwyer

2017-04-01

Full Text Available This study explores new product development in a strict regulatory and historically secretive environment. Adopting a systems perspective and a mixed methods approach in our research, we examine medical device development in Ireland. Findings indicate that the possession of a regulatory strategy expedites the rate of commercialization, so too does the generation of clear product definitions and marketing claims in the earliest developmental phases. Moreover, results suggest that if the regulated industry strengthens its culture for regulation by prioritizing regulation over speed to market, by encouraging cross-functional team collaborations, and by taking a more proactive approach in post-marketing surveillance activities, it has the potential to improve customer satisfaction and enhance product innovation. This study provides unique empirical data enriched by the homogeneity of its sample. It also contributes guidance to practitioners of new product development within a regulatory context.

Post operation: The changing characteristics of nuclear fuel cycle costs

International Nuclear Information System (INIS)

Frank, F.J.

1986-01-01

Fundamental changes have occurred in the nuclear fuel cycle. These changes forged by market forces, legislative action, and regulatory climate appear to be a long term characteristic of the nuclear fuel cycle. The nature of these changes and the resulting emerging importance of post-operation and its impact on fuel cycle costs are examined

76 FR 64403 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-10-18

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65381; File No. SR-NASDAQ-2011-128] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Customer Rebates To Add Liquidity September 22, 2011. Correction In notice...

State Electricity Regulatory Policy and Distributed Resources: Accommodating Distributed Resources in Wholesale Markets

Energy Technology Data Exchange (ETDEWEB)

Weston, F.; Harrington, C.; Moskovitz, D.; Shirley, W.; Cowart, R.; Sedano, R.

2002-10-01

Distributed resources can provide cost-effective reliability and energy services - in many cases, obviating the need for more expensive investments in wires and central station electricity generating facilities. Given the unique features of distributed resources, the challenge facing policymakers today is how to restructure wholesale markets for electricity and related services so as to reveal the full value that distributed resources can provide to the electric power system (utility grid). This report looks at the functions that distributed resources can perform and examines the barriers to them. It then identifies a series of policy and operational approaches to promoting DR in wholesale markets. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (2) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501

[Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

Science.gov (United States)

He, Wei; Xie, Yanming; Wang, Yongyan

2011-10-01

The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

[Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

Science.gov (United States)

Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

2017-08-01

As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels： optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects： mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

77 FR 42345 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

Science.gov (United States)

2012-07-18

..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... Book, it will be viewed as taking liquidity. Conversely, whenever a participant posts a bid or offer... economic advantage relative to a NYSE Amex Options Market Maker's cost when trading with Customer order...

78 FR 52994 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2013-08-27

... believes that the change will provide members with an additional tool for managing the book of [[Page 52995... Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

75 FR 78302 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2010-12-15

... last-sale price disseminated by a network processor over a five-minute rolling period measured...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of the Trading Pause for Individual Stocks Contained in the...

76 FR 76472 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-12-07

... at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... facility or system which NASDAQ operates or controls. \\7\\ 15 U.S.C. 78f. \\8\\ 15 U.S.C. 78f(b)(4). NASDAQ... Release No. 61358 (January 14, 2010), 75 FR 3594 (January 21, 2010) (Concept Release on Equity Market...

[Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

Science.gov (United States)

Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

2008-03-01

Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

Wholesale electricity markets in Europe

International Nuclear Information System (INIS)

Rios, J. L.

2010-01-01

Electricity Wholesale Markets provide efficient operation of power stations, facilitate hedging instruments for generators and retailers and deliver price signals for new investments. Despite having a common regulatory framework at European level whose last aim is a single electricity market, Wholesale markets have been unevenly developed in each Member State. The evolution form a spot-based market towards a forward-based market needs a certain level of liquidity, transparency and regulatory stability. Interconnections are the key element to promote the integration of electricity markets. To facilitate this, European Regional Initiatives have pushed regulatory harmonization between countries and market coupling projects. (Author)

State and market in post-reform Brazilian air transportation

Directory of Open Access Journals (Sweden)

Cristiano Fonseca Monteiro

2009-10-01

Full Text Available The changes that have taken place in Brazilian air transportation following the cycle of “market reforms” have turned this sector into an object of growing interest. This interest, in turn, has led to the emergence of a broad literature on the subject, characterized by the emphasis on an agenda of liberalization and the critique of State activism. The goal of the present article is to promote a confrontation between the different interpretations that have been made, incorporating the contributions of approaches inspired in Economic Sociology and in institutionalist analyses in order to draw attention to the importance that political variables, and the State in particular, have for economic performance. The post-reform context is characterized by an initial moment of greater State activism regarding air transportation, through re-initiation of stricter regulatory mechanisms and the re-opening of channels of dialog between state actors and firms. This is followed by a second moment in which state activism is abandoned, at the same time that the sector demonstrates expressive rates of growth, pushing it beyond its existing capacity and flight support infrastructure. This culminated in the episode known as the “apagão aéreo” (aerial black out Analysis of testimonies of state and private sector actors regarding the “blackout” enables us to identify the flaws in the responsible state apparatus as one of the factors that led to the “blackout”. Our conclusions draw attention to the importance of taking political factors into consideration, and particularly the role of the State, in the development of air transportation in Brazil. Keywords: commercial aviation, politics and economics, regulation, Economic Sociology, Historical Institutionalism.

The Impact of Active Labour Market Policy on Post-Unemployment Outcomes

DEFF Research Database (Denmark)

Blasco, Sylvie; Rosholm, Michael

While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which w......, the positive impact of the treatment becomes smaller but remains significant. 80% of the global impact of intensification acts through the direct channel for men.......While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which...... was conducted in Denmark in 2005-6, to investigate the effects of a dramatic intensification of ALMPs on reemployment stability. We investigate the nature of this impact. We estimate a duration model with lagged duration dependence to separately identify "indirect" (via shorter unemployment duration...

76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2011-07-28

...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

Science.gov (United States)

2013-10-22

... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

76 FR 19819 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-04-08

... each consolidated last-sale price disseminated by a network processor over a five minute rolling period...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of the Trading Pause for Individual Stocks Contained in the...

Electricity and telecommunications regulatory institutions in small and developing countries

Energy Technology Data Exchange (ETDEWEB)

Stern, J. [London Business School, London (United Kingdom)

2000-09-01

The spread of utility liberalisation and privatisation to middle and low income developing countries raises the problem of whether and how they can establish an effective regulatory capability of whether the supply of regulatory services is likely to be insufficient. The paper presents evidence on the size of electricity regulatory agencies in 24 mainly middle and lower income countries as well as the number of high-level, specialist regulatory staff and the potential resource pool from post-school education. The paper also discusses how far the problem can be alleviated and/or avoided by the use of regulation by contract, regulation by multi-national regulatory agency or contracting-out. The paper concludes that such solutions are unlikely to be generally effective but that informal exchanges of information and pooling of resources between national regulators on a market-driven basis, as seen in Southern Africa and the EU, is a promising option. The paper concludes by pointing to the need to ascertain the minimum required regulatory capability in developing countries as perceived by Governments and potential investors. (author)

Elucidating MicroRNA Regulatory Networks Using Transcriptional, Post-transcriptional, and Histone Modification Measurements

Directory of Open Access Journals (Sweden)

Sara J.C. Gosline

2016-01-01

Full Text Available MicroRNAs (miRNAs regulate diverse biological processes by repressing mRNAs, but their modest effects on direct targets, together with their participation in larger regulatory networks, make it challenging to delineate miRNA-mediated effects. Here, we describe an approach to characterizing miRNA-regulatory networks by systematically profiling transcriptional, post-transcriptional and epigenetic activity in a pair of isogenic murine fibroblast cell lines with and without Dicer expression. By RNA sequencing (RNA-seq and CLIP (crosslinking followed by immunoprecipitation sequencing (CLIP-seq, we found that most of the changes induced by global miRNA loss occur at the level of transcription. We then introduced a network modeling approach that integrated these data with epigenetic data to identify specific miRNA-regulated transcription factors that explain the impact of miRNA perturbation on gene expression. In total, we demonstrate that combining multiple genome-wide datasets spanning diverse regulatory modes enables accurate delineation of the downstream miRNA-regulated transcriptional network and establishes a model for studying similar networks in other systems.

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...

77 FR 8936 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2012-02-15

... defined as ``the ratio of (A) the total number of liquidity-providing orders entered by a member through... trading sessions. (3) The ratio between shares of liquidity provided through the MPID and total shares..., or pre-market and/or post- market hours; and to maintain a high ratio of liquidity provision to order...

Rethinking capital markets reform: a reassessment of Olson problem and regulatory dualism in the German capital markets from a varieties of capitalism perspective

Directory of Open Access Journals (Sweden)

André Ziccardi de Carvalho

2015-09-01

Full Text Available Since its proposition by Peter A. Hall and David Soskice the Varieties of Capitalism (VoC approach has been particularly important to explain the relationship between economic agents and sets of institutional arrangements that, even in regulatory scenarios that Law and Finance’s school would consider “less than optimal”, are able to generate sustainable economic growth. In this context the VoC approach has been consistently challenging the traditional “one fits all” approach towards capital markets reform usually endorsed by institutions such as the World Bank and the International Monetary Fund, as well as by many scholars and capital markets regulators associated with La Porta’s Law and Finance School. As any theoretical framework, however, the VoC approach also faces its own challenges and still lacks the scientific maturity achieved by the Law and Finance School. Consequently a conciliation between the relational view of the firm proposed by the VoC approach and the overview of corporate governance practices throughout the world presented by the Law and Finance School would be instrumental to construe a more clear understanding of the competitive advantages generated by certain sets of institutions and, at the same time, more accurately assess impacts of reforms that, even if implemented with the legitimate goal of promoting firms’ transparency and higher corporate governance standards, may counter-intuitively generate unprecedented corporate and capital markets crisis. By analyzing two concepts proposed by Ronald J. Gilson, Henry Hansmann and Mariana Pargendler that have an apparent fundamental link to La Porta’s school of Law and Finance (i.e. Olson Problem and Regulatory Dualism through a varieties of capitalism approach, this study aims at rethinking the traditional “one fits all” approach towards capital markets reform and taking a further step in the direction of conciliating the VoC approach with La Porta’s Law

Bulgarian electricity market restructuring

International Nuclear Information System (INIS)

Ganev, Peter

2009-01-01

The energy sector in Bulgaria has undergone major restructuring in recent years. It faces the dual challenges of achieving regulatory stability to attract private investors, and creating a functioning competition energy market. As of the EU Accession in 2007, Bulgaria has fully liberalized power and gas markets. The 2003 Energy Law establishes the energy sector legal framework and sets the basis for creation of a transparent and predictable regulatory environment where the key regulatory responsibilities are vested with the State Energy and Water Regulatory Commission (SEWRC). The energy sector experienced significant problems in the first half of 2007 due to lost production capacities and regulatory failures on the electricity market. Excess price regulations on the market of electricity supplies to household, coupled with insufficient liberalization of imports and exports, create unfavorable conditions for power producers and large electricity users. The energy regulator has tried to achieve several incompatible targets as of July 1, 2007 for maintaining low electricity prices for households in response to political pressure, low power generation prices amid rising input costs, and market opening in compliance with EU regulations. (author)

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

Directory of Open Access Journals (Sweden)

J.B. Calixto

2000-02-01

Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

Understanding banking regulatory and market framework in South Africa including the perceived strength, weaknesses, opportunities and threats

Directory of Open Access Journals (Sweden)

Tankiso Moloi

2014-08-01

Full Text Available Following the global financial crisis of 2007, the manner in which banks conduct their business became the subject of interest to authorities. In South Africa, most analysts argued that the financial system was insulated by the prudent regulatory system. This paper reviewed the banking regulation and market framework applicable in the South African context. In reviewing regulation and banking market framework, it was found that the principal legal instrument which seeks to achieve credibility, stability and economic growth, is the Banks Act, No. 94 of 1990 (the Banks Act. Considering the applicable regulation, the paper concluded that South Africa has a developed and well regulated banking system which compares favourably with regulatory environment applied by the developed countries. It was, however; cautioned that further regulation such as the recently announced ‘Twin Peaks’ approach to financial regulation could result in unintended consequences, such as driving a larger share of activity into the shadow banking sector.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

Science.gov (United States)

Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

2017-12-19

Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Do societal values influence financial development? : New evidence on the effects of post materialism and institutions on stock markets

NARCIS (Netherlands)

Jordaan, J.A.; Dima, Dogdan; Goleț, Ionuț

2016-01-01

In this paper we present new evidence on the effects of social values on stock market development. Using panel data for a heterogeneous set of 43 countries, we use the Inglehart post materialism index to identify the relation between the degree of post materialism and the size of stock markets.

[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

Science.gov (United States)

Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

2013-11-01

By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

Revisiting Stock Market Integration Pre-Post Subprime Mortgage Crisis: Insight From BRIC Countries

Directory of Open Access Journals (Sweden)

Chin-Hong Puah

2015-07-01

Full Text Available This study revisits the long-run relationships and short-run dynamic causal linkages among BRIC stock market, with the particular attention to the 2008 subprime mortgage crisis. Extending related empirical studies, comparative analyses of pre-crisis, and post-crisis periods were conducted to comprehensively evaluate how stock market integration was affected by financial crises. In general, after employing cointegration test and VAR test, the results reveal the increase of stock market integration in BRICs after the subprime crisis. The evidence also found that China stock market is the most influential among the BRICs, in which China stock market has the ability to Granger cause the other three BRICs member countries. An important implication of our findings is that the degree of integration among countries tends to change over time, especially around periods marked by financial crises.

Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

Science.gov (United States)

Singh, G

2001-05-01

The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

Science.gov (United States)

Komparic, Ana; Smith, Maxwell J; Thompson, Alison

2016-04-01

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

Science.gov (United States)

Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

2017-10-01

This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

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)

[Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

Science.gov (United States)

Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

2013-09-01

To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

Impacts of the regulatory model for market risk capital: application in a special savings company, an insurance company, and a pension fund

Directory of Open Access Journals (Sweden)

Betty Lilian Chan

Full Text Available ABSTRACT In line with the regulation brought in by Solvency II, the Superintendence of Private Insurance (Susep introduced the market risk capital requirement at the end of 2015, with 50% of the minimum capital for this type of risk being required by December 31st 2016 and 100% the following year. This regulatory model consists of calculating parametric value at risk with a 99% confidence level and a three month time horizon, using the net exposure of expected cash flows from assets and liabilities and a covariance matrix updated with market data up to July 2014. One limitation of this regulatory approach is that the updating of the covariance matrix depends on prior approval by the National Council of Private Insurance, which can limit the frequency the covariance matrix is updated and the model’s adherence to the current market reality. As this matrix considers the period before the presidential election, the country’s loss of investment grade status, and the impeachment process, which all contributed to an increase in market volatility, this paper analyses the impacts of applying the regulatory model, considering the market volatility updated to December 31st 2015, for a special savings company (sociedade de capitalização, an insurance company, and an pension fund. Furthermore, the paper discusses the practical implications of the new market risk requirement for managing the investments of the entities supervised by Susep, listing the various assumptions that can be used in the regulated entities’ Asset and Liability Management decision models and possible trade-offs to be addressed in this process.

Disclosure as a regulatory tool

DEFF Research Database (Denmark)

Sørensen, Karsten Engsig

2006-01-01

The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

[Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

Science.gov (United States)

Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

2013-09-01

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

Regulatory frameworks for decentralised energy

International Nuclear Information System (INIS)

Woodman, Bridget; Baker, Philip

2008-01-01

This paper considers aspects of the current regulatory frameworks for markets and infrastructure which can inhibit the deployment of decentralised energy. The government has stated that decentralised energy can make a positive contribution to reducing the UK's carbon emissions, but recognises that at the moment the technologies face market and regulatory barriers. If it is to become a viable alternative to centralised generation, energy market design and the regulation of energy infrastructure will have to evolve to ensure that decentralised options are no longer locked out. (author)

Sample size for post-marketing safety studies based on historical controls.

Science.gov (United States)

Wu, Yu-te; Makuch, Robert W

2010-08-01

As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

Essays on market design and strategic behaviour in energy markets

International Nuclear Information System (INIS)

Lorenczik, Stefan

2017-01-01

The thesis at hand consists of four essays which are divided into two parts. In the first part, consisting of the first two essays, market design issues in electricity markets are discussed. More precisely, it deals with concerns regarding security of supply: First, the concerns regarding the availability of sufficient flexibility to cope with intermittent renewable energy electricity generation. And second, the consequences of insufficient investments signals in energy only markets in interconnected electricity markets. Part two deals with strategic behaviour in spatial natural resource markets. Strategic behaviour and the exertion of market power have always been a matter of concern in energy markets, especially in natural resource markets. The exertion of market power can result in deadweight losses - regulatory bodies try to address this by market regulations aiming for a welfare maximising market outcome. The first problem is to detect collusive behaviour as available data is frequently limited. The second question is how regulatory decisions may influence the market outcome. Both topics are investigated by using the example of the international metallurgical coal market.

Essays on market design and strategic behaviour in energy markets

Energy Technology Data Exchange (ETDEWEB)

Lorenczik, Stefan

2017-11-13

The thesis at hand consists of four essays which are divided into two parts. In the first part, consisting of the first two essays, market design issues in electricity markets are discussed. More precisely, it deals with concerns regarding security of supply: First, the concerns regarding the availability of sufficient flexibility to cope with intermittent renewable energy electricity generation. And second, the consequences of insufficient investments signals in energy only markets in interconnected electricity markets. Part two deals with strategic behaviour in spatial natural resource markets. Strategic behaviour and the exertion of market power have always been a matter of concern in energy markets, especially in natural resource markets. The exertion of market power can result in deadweight losses - regulatory bodies try to address this by market regulations aiming for a welfare maximising market outcome. The first problem is to detect collusive behaviour as available data is frequently limited. The second question is how regulatory decisions may influence the market outcome. Both topics are investigated by using the example of the international metallurgical coal market.

Pharmaceutical market access in emerging markets: concepts, components, and future.

Science.gov (United States)

Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

2014-01-01

This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities.

Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

Science.gov (United States)

Raschi, Emanuel; De Ponti, Fabrizio

2015-07-08

Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.

Science.gov (United States)

Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

2018-01-01

Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index. We included licensed analgesics that were withdrawn after marketing because of adverse reactions between 1950 and March 2017. We excluded herbal products, non-human medicines, and non-prescription medicines. We used the Oxford Centre for Evidence Based Medicine criteria to document the levels of evidence, and chi-squared tests to compare withdrawal patterns across geographical regions. Expert opinion: Pharmacovigilance systems in low-resource settings should be strengthened. Greater co-ordination across regulatory authorities in assessing and interpreting the benefit-harm balance of new analgesics should be encouraged. Future reporting of harms in clinical trials of analgesics should follow standardized guidelines.

Market Segmentation, Information Asymmetry and Investor Responses in the Chinese A- and B- Markets

Directory of Open Access Journals (Sweden)

Juan Yao

2014-03-01

Full Text Available This paper examines changes in returns and trading volumes around earnings announcements for firms which have both A-shares (traditionally for local investors only and B-shares (traditionally for foreign investors only in China. It considers the impact of regulatory changes which reduced the segmentation of local and foreign investors across the two classes of shares. We find that both the A- and B-markets experience significant price changes around earning announcements. When the two markets are fully segmented, the magnitude of price changes in the A-share market are significantly smaller than the B-market which lends empirical support to the previous claim that the B-market is less informed. The changes in trading volume indicate that the B-market investors have less divergent expectations and interpretations of the pre-disclosure information compared to the A-market investors.However, when regulatory changes reduced the level of segmentation, the price and volume reactions in the two markets became more consistent. The results suggest that the A- and Bmarkets are more integrated as a result of the regulatory changes.

76 FR 3679 - Market Test of Marketing Mail Made Easy

Science.gov (United States)

2011-01-20

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-3; Order No. 649] Market Test of Marketing Mail... recently-filed Postal Service proposal to conduct a 2-year market test involving the sale of Marketing Mail..., 2011. ADDRESSES: Submit comments electronically via the Commission's Filing Online system at http://www...

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.

Croatian energy regulatory council - independent Croatian regulatory body

International Nuclear Information System (INIS)

Klepo, M.

2002-01-01

By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

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

The New Electricity Market of Singapore: Regulatory framework, market power and competition

International Nuclear Information System (INIS)

Chang Youngho

2007-01-01

This study examines whether the New Electricity Market of Singapore (NEMS) is functioning at a workable level of competition. The generation market of the NEMS appears highly concentrated by a four-firm concentration ratio or the Herfindahl-Hirschman Index. However, other measures of market power present that the NEMS is working at close to a competitive market. First, there seems to be a number of effective competitors in the market. Second, Supply Margin Assessment and Residual Supply Index support that the market is competitive though there are some possibilities in which the largest generator or a few large generators jointly could still have market power. Third, the Lerner Index of the NEMS shows that the generation market is fairly competitive and the Lerner Index adjusted with an industry level price elasticity of demand implies that there has not been much exercise of market power. Finally, vesting contracts-a contractual obligation of a specified quantity of electricity supply to the market-have appeared to be a strong and effective tool to mitigate market power in the NEMS. The vesting contracts are considered the force behind the lowering in the average Uniform Singapore Electricity Price and the Lerner Index in 2004

The New Electricity Market of Singapore : regulatory framework, market power and competition

International Nuclear Information System (INIS)

Chang, Y.

2007-01-01

This study examines whether the New Electricity Market of Singapore (NEMS) is functioning at a workable level of competition. The generation market of the NEMS appears highly concentrated by a four-firm concentration ratio or the Herfindahl-Hirschman Index. However, other measures of market power present that the NEMS is working at close to a competitive market. First, there seems to be a number of effective competitors in the market. Second, Supply Margin Assessment and Residual Supply Index support that the market is competitive though there are some possibilities in which the largest generator or a few large generators jointly could still have market power. Third, the Lerner Index of the NEMS shows that the generation market is fairly competitive and the Lerner Index adjusted with an industry level price elasticity of demand implies that there has not been much exercise of market power. Finally, vesting contracts - a contractual obligation of a specified quantity of electricity supply to the market - have appeared to be a strong and effective tool to mitigate market power in the NEMS. The vesting contracts are considered the force behind the lowering in the average Uniform Singapore Electricity Price and the Lerner Index in 2004. [Author

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

Science.gov (United States)

Sood, Des R.

1991-01-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

Direct broadcast satellite-radio market, legal, regulatory, and business considerations

Science.gov (United States)

Sood, Des R.

1991-03-01

A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

Assessment of the effectiveness of the post-Fukushima food monitoring campaign in the first year after the nuclear accident: A hypothesis

International Nuclear Information System (INIS)

Steinhauser, Georg

2016-01-01

The purpose of this study was to assess whether or not the food monitoring campaign after the Fukushima nuclear accident has been successful in reducing the number of above-limit-food from reaching the consumers. The hypothesis of this study is that the fraction of “post-market” food can be used for this purpose, when the post-market fraction in the above-limit (p′) items is compared to the post-market fraction in the entity of food items (p) that have been screened for radionuclides ("1"3"4Cs and "1"3"7Cs). Indeed the post-market fraction in most vegetarian produce decreased significantly in the above-limit food items (p′/p   1), indicating a much lower effectiveness of the monitoring action for beef. The author speculates that, by following the governmental monitoring manual (which gives “meat” only second priority), the sudden exceedances caught the monitoring agencies unprepared and triggered a much higher density monitoring of beef with the delay of several weeks. Even then, many above limit items reached the market (mainly because the monitoring during this period had focused on the post-market). Therefore, it is likely that some above-limit beef has been consumed by the public. For other meat products, the fraction of post-market samples was very low, which does not allow for the validation of the effectiveness of the monitoring campaign. Overall, the monitoring seemed to have been more effective for vegetarian produce than for meat. - Highlights: • The fraction of post-market food above the regulatory indicates the effectiveness of the monitoring campaign. • Monitoring of vegetables has been more effective than of meat. • Beef had the highest fraction of exceedances in the post-market fraction.

Comparison of Group-Buying Online Auction and Posted Pricing Mechanism in an Uncertain Market

Institute of Scientific and Technical Information of China (English)

CHEN Jian; LIU Yunhui; SONG Xiping

2004-01-01

Demand uncertainty is a key factor for the seller's decision making, especially in the e-business environment, for the website to sell products through the online auction. In this paper, two kinds of demand uncertainties are considered: the consumer regime uncertainty and the inherent randomness of the market environment. Then, how to use a novel business model and group-buying auction (GBA) is analyzed in such a market environment. Based on the comparison of the GBA and the posted price mechanism, some conditions that favor the GBA are provided.

European Regulatory Framework for Money Market Funds

OpenAIRE

Portuese, Aurelien; MacNeil, Iain

2014-01-01

Money market funds are widely used by all types of investors, including households, corporate treasurers, pension funds, or insurance companies, who regard money market funds as a ‘safe’ short-term liquid asset class for investing cash. In this case they are proxies to cash deposits. Money market funds are themselves key lenders to issuers of short dated high quality money market instruments. They provide an important source of funding for a variety of institutions such as sovereigns, banks, ...

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

Science.gov (United States)

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

[Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

Science.gov (United States)

Inagaki, Osamu

2016-04-01

Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

Overcoming regulatory and economic challenges facing pharmacogenomics.

Science.gov (United States)

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

Science.gov (United States)

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

Romanticizing the Market

DEFF Research Database (Denmark)

Johnsen, Christian Garmann

2016-01-01

is echoed in post-bureaucratic management literature. Comparing Rousseau's romanticization of nature with what I call the romanticization of markets, I show how the post-bureaucratic management literature employs the logic of market rationalism to generate a managerial pedagogy that installs the market...

A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

Science.gov (United States)

Hay, C R; Lee, C A; Savidge, G

1996-01-01

The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

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...

Changes in the volume, power and nutritional quality of foods marketed to children on television in Canada

Science.gov (United States)

Potvin Kent, Monique; Martin, Cherie L; Kent, Emily A

2014-01-01

Objective To evaluate the self-regulatory Children's Food and Beverage Advertising Initiative pre- and post-implementation in terms of volume of marketing, marketing techniques, and nutritional quality of foods marketed to children on television. Methods Data for 11 food categories for May 2006 and 2011 were purchased from Nielsen Media Research for two children's specialty channels in Toronto. A content analysis of food advertisements examining the volume and marketing techniques was undertaken. Nutritional information on each advertisement was collected and comparisons were made between 2006 and 2011. Results The volume of ads aired by Canadian Children's Food and Beverage Advertising Initiative (CAI) companies on children's specialty channels decreased by 24% between 2006 and 2011; however, children and teens were targeted significantly more, and spokes-characters and licensed characters were used more frequently in 2011 compared to 2006. The overall nutritional quality of CAI advertisements remains unchanged between 2006 and 2011. Conclusion There are clear weaknesses in the self-regulatory system in Canada. Food advertising needs to be regulated to protect the health of Canadian children. PMID:24975614

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

Science.gov (United States)

Lang, Achim

2014-01-01

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

Science.gov (United States)

Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

78 FR 47457 - Self-Regulatory Organizations: Miami International Securities Exchange LLC; Notice of Filing and...

Science.gov (United States)

2013-08-05

... innovative pricing strategy. The Exchange notes that if the extension of the fee waiver results in a modest... to Market Makers including marketing fees, Options Regulatory Fees, market data, and membership... may apply to Market Makers including marketing fees, Options Regulatory Fees, market data, and...

78 FR 35349 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and...

Science.gov (United States)

2013-06-12

... by adopting an innovative pricing strategy. The Exchange notes that if the fee waiver resulted in a... apply to Market Makers including marketing fees, Options Regulatory Fees, market data, and membership... Market Makers including marketing fees, Options Regulatory Fees, market data, and membership application...

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

Science.gov (United States)

Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

2015-01-01

With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

Science.gov (United States)

Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

2008-12-01

We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Adjustable consumption participating in the electricity markets

DEFF Research Database (Denmark)

Biegel, Benjamin; Hansen, Lars Henrik; Stoustrup, Jakob

2013-01-01

are aggregated and utilized for spot price optimization and to participate in the regulating power market. In this case study we examine in detail the implications of the given regulatory requirements for market participation in the Nordic system and compare this with estimates of the revenue that can...... be generated via market participation. The case study shows that the profit in the current system is very limited but that planned regulatory changes will make market participation significantly more attractive....

Wholesale electricity markets in Europe; Mercados Mayoristas de Electricidad en Europa

Energy Technology Data Exchange (ETDEWEB)

Rios, J. L.

2010-07-01

Electricity Wholesale Markets provide efficient operation of power stations, facilitate hedging instruments for generators and retailers and deliver price signals for new investments. Despite having a common regulatory framework at European level whose last aim is a single electricity market, Wholesale markets have been unevenly developed in each Member State. The evolution form a spot-based market towards a forward-based market needs a certain level of liquidity, transparency and regulatory stability. Interconnections are the key element to promote the integration of electricity markets. To facilitate this, European Regional Initiatives have pushed regulatory harmonization between countries and market coupling projects. (Author)

Cellular therapy injections in today's orthopedic market: A social media analysis.

Science.gov (United States)

Ramkumar, Prem N; Navarro, Sergio M; Haeberle, Heather S; Chughtai, Morad; Demetriades, Christopher; Piuzzi, Nicolas S; Mont, Michael A; Bauer, Thomas W; Muschler, George F

2017-12-01

The current state of cellular therapy for musculoskeletal conditions is at a crossroads. Marketing efforts are often outpacing clinical evidence and regulatory control. This study was an effort to describe the marketing of cellular therapy in musculoskeletal medicine by evaluating the content in popular social media channels. Specifically, media posts were evaluated for the following: (1) perspective, (2) tone, (3) content and (4) visibility. Social media content related to cell therapy for musculoskeletal conditions was assessed in a search using 28 hashtags on the public domains of Instagram and Twitter over a 2-year period (2014-2016) that resulted in analysis of 698 posts. Supplemental analyses of LinkedIn and Facebook domains were also conducted. A categorical scoring system was used to analyze perspective (patient, family or friend, business or organization), tone (positive, negative), content (education, advertisement, research, media coverage or patient experience) and visibility (number of hashtags per post). Sub-analyses of the advertisement content from various perspectives (patients, physicians and businesses) were performed. The media perspective was most frequently from a business or organization (83%; n = 575). A total of 94% of the posts had a positive tone and only 6% had a negative tone, and the only negative posts came from patients (60% positive and 40% negative). The most common content of social media posts were advertisements, representing 68% (n = 477) of all posts; this was confirmed in the Facebook analysis. The mean number of hashtags was five per post. Sub-analyses revealed approximately half of the advertising posts originated from a single business that recruited physicians to market their cell-based therapies on social media, which was confirmed in the LinkedIn analysis. The market messages related to cell-based therapies for musculoskeletal conditions available on social media are dominated by businesses that seem to use a

76 FR 2178 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-01-12

... to provide non-displayed liquidity to offer an alternative to trading venues that are entirely dark... impact of the price changes upon the net fees paid by a particular market participant will depend upon a... method. The Commission will post all comments on the Commission's Internet Web site ( http://www.sec.gov...

Entry, concentration and market efficiency: A simulation of the PJM energy market

Science.gov (United States)

Harvill, Terry

The rapid and substantial expansion of the PJM energy market during 2004 and 2005 provides a unique opportunity to test the theory of market concentration and its effect on market efficiency. With ten years of operational experience, the PJM energy market is uniquely suited to test the theories of market concentration and efficiency in a natural experiment. This research tests the hypothesis that, for a given number of generating units in the industry, system marginal price will be a decreasing function of the number of owners or generators controlling the units (i.e., the industry concentration ratio). Market simulations are utilized to assess price-cost markups in the PJM energy market during three distinct periods of expansion: (1) pre-Commonwealth Edison integration, (2) pre-American Electric Power (AEP), Dayton Power and Light (DPL), Duquesne Light (Duquesne), and Dominion Virginia Power (Dominion) integration, and (3) post-AFT, DPL. Duquesne, and Dominion Integration. The results of the market simulations for the May 1 to August 31 periods for 2003, 2004, and 2005, indicate that the performance of the market improved with the addition of new market participants in 2004 and 2005. The results of the simulation indicate that the load-weighted Lerner index decreased to -3.70 percent in 2005 from 0.92 percent in 2003. Clearly, the addition of Commonwealth Edison in 2004 significantly increased constraints within the PJM energy market and likely impacted the observed prices in PJM during 2004 due to the lack of a significant link to the other PJM market participants. This deficiency was address in 2005 with the addition of American Electric Power. The market simulations also highlight the prevalence of computed negative markups in the simulation results. Many of the off-peak periods in particular are characterized by negative markups where the expected marginal cost exceeds the observed price. Unit commitment constraints are believed to largely account for these

Schedules for Regulatory Regimes

International Nuclear Information System (INIS)

Austvik, Ole Gunnar

2003-01-01

The idea of regulating transporters' terms of operations is that if the market itself does not produce optimal outcomes, then it can be mimicked to do so through regulatory and other public instruments. The first-best solution could be a subsidized (publicly owned) enterprise that sets tariffs according to marginal costs. This has been the tradition in many European countries in the aftermath of WW2. Due to lack of innovative pressure on and x-inefficiency in these companies, this solution is today viewed as inferior to the system of regulating independent (privately owned) firms. When the European gas market becomes liberalized, part of the process in many countries is to (partially) privatise the transport utilities. Privatised or not, in a liberalized market, the transport utilities should face an independent authority that overviews their operations not only in technical, but also in economic terms. Under regulation, a ''visible hand'' is introduced to correct the imperfect market's ''invisible hand''. By regulating the framework and conditions for how firms may operate, public authorities seek to achieve what is considered optimal for the society. The incentives and disincentives given for pricing and production should create mechanisms leading to an efficient allocation of resources and ''acceptable'' distribution of income. As part of intervening into firms' behavior, regulation may be introduced to direct the firm to behave in certain ways. The framework and regulatory mechanisms for the market must then be constructed in a way that companies voluntarily produce an amount at a price that gives maximal profits and simultaneously satisfies social goals. The regulations should lead to consistency between the company's desire to maximize profits and the society's desire for maximizing welfare, as in a perfectly competitive market. This is the core of regulatory economics

The regulatory dynamic

International Nuclear Information System (INIS)

Dybwad, C.

2001-01-01

An outline of the activities and efforts expanded by the National Energy Board to adjust to the changing natural gas market was provided in this presentation. The author began by defining the role of the National Energy Board in energy markets. It must ensure the adoption of rules and procedures that result in a more competitive and efficient market. Light-handed regulatory techniques are the norm, and the National Energy Board is now committed to facilitating the availability and flow of information so that all parties know where opportunities exist, the terms offered to buy or sell goods and services, their quality and costs. It will specialize in providing new participants with information on the workings of the market, who the players are, the regulatory processes in place, and how, when and where the market can be accessed. The manner in which the Board deals with information was reviewed, providing examples along the way to clarify some points. Some of the documents produced by the National Energy Board are being reviewed with the intent of making them easier to read and understand. Audio streaming over the Internet is another avenue being pursued to ensure individuals can listen in real time to hearings without having to be present in the room. The National Energy Board is also exploring alternative dispute resolution techniques. Consultation with energy market participants represents another facet of these efforts to be more accessible and responsive

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

Science.gov (United States)

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

Condom social marketing program to prevent HIV/AIDS in post-conflict Liberia.

Science.gov (United States)

Harris, A O; Jubwe, S; Kennedy, S B; Taylor, C H; Martin, R B; Bee, E M; Perry, O S; Massaquoi, M T; Woods, D V; Barbu, E M

2011-08-01

Youths in sub-Saharan Africa (SSA) account for a large burden of the global HIV/STI crises. As such, strategies directed at promoting behavioral modifications would be critical to reducing the prevalence of risky sexual behaviors among high risk adolescents in post-conflict environments. This study describes a condom promotion strategy to prevent HIV/STIs among highly vulnerable urban youth in a post-conflict, resource-constrained environment via the provision of both male and female condoms to nontraditional venues like music and photo shops, ice cream parlors, money exchange centers and beauty salons. Community members in the designated catchment areas volunteered their services and the use of their small businesses to support this endeavor. In this paper, we describe the condom promotion strategy and its implications within the context of a community-based participatory social marketing program to prevent risky sexual behaviors among highly vulnerable urban youth in a post-conflict country. We postulate that this approach may likely increase condom use among urban youth in Monrovia, the capital city of Liberia.

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...

Regulatory actions post - Fukushima

International Nuclear Information System (INIS)

Ciurea Ercau, C.

2013-01-01

The paper presents the results of the safety reviews performed in Romania after the Fukushima accident and the resulting actions for improving the safety. The actions taken by the National Commission for Nuclear Activities Control (CNCAN) to improve the regulatory framework include the development of new regulations and the enhancement of inspection practices, taking account of the lessons learned from the Fukushima accident. A regulation on the response to transients, accidents and emergency situations at nuclear power plants has been developed, which includes requirements on transient and accident scenarios that have to be covered by the Emergency Operating Procedures (EOPs), accident scenarios to be covered by the Severe Accident Management Guidelines (SAMGs), emergency situations to be covered by the on-site emergency response plan and emergency response procedures. (authors)

A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

Directory of Open Access Journals (Sweden)

Yamamoto K

2011-04-01

Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

77 FR 8082 - Regulatory Flexibility Agenda

Science.gov (United States)

2012-02-13

... Required: Yes. Agency Contact: Alicia Goldin, Division of Trading and Markets, Securities and Exchange.../01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of... Withdrawn 10/01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of...

A decision support tool for the analysis of pricing, investment and regulatory processes in a decentralized electricity market

International Nuclear Information System (INIS)

Pasaoglu Kilanc, Guzay; Or, Ilhan

2008-01-01

After the liberalization of the electricity generation industry, capacity expansion decisions are made by multiple self-oriented power companies. Unlike the centralized environment, decision-making of market participants is now guided by price signal feedbacks and by an imperfect foresight of the future market conditions (and competitor actions) that they will face. In such an environment, decision makers need to better understand long-term dynamics of the supply and demand sides of the power market. In this study, a system dynamics model is developed, to better understand and analyze the decentralized and competitive electricity market dynamics in the long run. The developed simulation model oversees a 20-year planning horizon; it includes a demand module, a capacity expansion module, a power generation module, an accounting and finance module, various competitors, a regulatory body and a bidding mechanism. Many features, singularities and tools of decentralized markets, such as; capacity withholding, enforced divestment, long-term contracts, price-elastic demands, incentives/disincentives, are also incorporated into the model. Public regulators and power companies are potential users of the model, for learning and decision support in policy design and strategic planning. Results of scenario analysis are presented to illustrate potential use of the model

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

Energy Technology Data Exchange (ETDEWEB)

Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

2015-11-15

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

Science.gov (United States)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

International Nuclear Information System (INIS)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

2015-01-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

Science.gov (United States)

Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

2016-04-06

The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

[Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

Science.gov (United States)

Xiao, Ying; Zhao, Yubin; Xie, Yanming

2011-10-01

The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

A Post-Modern Portfolio Management Approach on CEE Markets

Directory of Open Access Journals (Sweden)

Marcela-Daniela Todoni

2015-01-01

Full Text Available In this paper we apply two methods based on the Post-Modern Portfolio Management approach to study the risk-adjusted return of 5 major indices from emerging markets in Central and Eastern Europe during the period 2008-2013 on daily data. First, we involve the Sortino ratio. Secondly we propose an alternative method to the Sortino ratio for calculating the risk-adjusted return using a “multipliers method” to determine a global measure of risk. The Sortino ratio is used to score a portfolio's risk-adjusted returns relative to an investment target using downside risk and it measures the risk-adjusted return of an investment asset, portfolio or strategy. Our proposed alternative method is using the same logic and frame structure as Sortino ratio. However instead of downside risk we use the global risk calculated using multipliers. This is due to the fact that Sortino ratio does not distinguish between sub-cases possible – unrealized return area and loss area (negative return. Because of these we believe that it would be necessary a new method which to refine the results and take and into account the three areas. Our dataset includes 5 emerging markets: Romania (BET, Hungary (BUX, Czech Republic (PX, Bulgaria (SOFIX and Poland (WIG. For each of them we estimate the Sortino ratio of length windows 7, 14, 42 and 10, 21, 60. We used two variants for each target return, namely 2% and 5%. We consider Germany as a benchmark. After estimating the Sortino ratio and global risk calculated using “multipliers method”, we conducted a parallel analysis between Sortino ratio and the proposed alternative method. We split the analysis time span in two sub-periods, 2008-2010 and 2011-2013. As known, the higher the Sortino ratio, the better the risk-adjusted performance. The risk-adjusted return is influenced by the used target return and the used window. Analyzed data reveals that in case of Sortino ratio, Hungary has the best results and on the other side

[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

Science.gov (United States)

Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

2012-03-01

Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

Evaluation of the trading development in the Iberian Energy Derivatives Market

International Nuclear Information System (INIS)

Capitán Herráiz, Álvaro; Rodríguez Monroy, Carlos

2012-01-01

The efficiency of the Iberian Energy Derivatives Market in its first five and a half years is assessed in terms of volume, open interest and price. The continuous market shows steady liquidity growth. Its volume is strongly correlated to that of the Over The Counter (OTC) market, the amount of market makers, the enrolment of financial agents and generation companies belonging to the integrated group of last resort suppliers, and the OTC cleared volume in its clearing house. The hedging efficiency, measured through the ratio between the final open interest and the cleared volume, shows the lowest values for the Spanish base load futures as they are the most liquid contracts. The ex-post forward risk premium has diminished due to the learning curve and the effect of the fixed price retributing the indigenous coal fired generation. This market is quite less developed than the European leaders headquartered in Norway and Germany. Enrolment of more traders, mainly international energy companies, financial agents, energy intensive industries and renewable generation companies is desired. Market monitoring reports by the market operator providing post-trade transparency, OTC data access by the energy regulator, and assessment of the regulatory risk can contribute to efficiency gains. - Highlights: ► The continuous traded volumes in the Iberian power futures market grow steadily. ► Those volumes are correlated to OTC volumes and the enrolment of key players. ► Most liquid contracts show the smallest hedging ratio. ► Regulation fixing the coal fired generation price affects spot and forward prices. ► The overall efficiency can grow via market monitoring reports and OTC data access.

Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

Science.gov (United States)

Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

2014-01-01

Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles.

Science.gov (United States)

MacDonald, Jacqueline; Doshi, Ketan; Dussault, Marike; Hall, J Christopher; Holbrook, Larry; Jones, Ginny; Kaldis, Angelo; Klima, Cassidy L; Macdonald, Phil; McAllister, Tim; McLean, Michael D; Potter, Andrew; Richman, Alex; Shearer, Heather; Yarosh, Oksana; Yoo, Han Sang; Topp, Edward; Menassa, Rima

2015-12-01

The production of recombinant vaccines in plants may help to reduce the burden of veterinary diseases, which cause major economic losses and in some cases can affect human health. While there is abundant research in this area, a knowledge gap exists between the ability to create and evaluate plant-based products in the laboratory, and the ability to take these products on a path to commercialization. The current report, arising from a workshop sponsored by an Organisation for Economic Co-operation and Development (OECD) Co-operative Research Programme, addresses this gap by providing guidance in planning for the commercialization of plant-made vaccines for animal use. It includes relevant information on developing business plans, assessing market opportunities, manufacturing scale-up, financing, protecting and using intellectual property, and regulatory approval with a focus on Canadian regulations. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

[The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

Science.gov (United States)

Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

2017-01-01

In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

Economics and business administration post-graduates in transition from university to work: Labor market success factors

NARCIS (Netherlands)

Bijker, Monique; Van der Klink, Marcel; Boshuizen, Els

2012-01-01

Bijker, M. M., Van der Klink, M. R., & Boshuizen, H. P. A. (2012, 13-17 April). Economics and business administration post-graduates in transition from university to work: Labor market success factors. Paper presented at the Annual Meeting of the American Education Research Association (AERA),

Multiple post-transcriptional regulatory mechanisms in ferritin gene expression

International Nuclear Information System (INIS)

Mattia, E.; Den Blaauwen, J.; Van Renswoude, J.; Ashwell, G.

1989-01-01

The authors have investigated the mechanisms involved in the regulation of ferritin biosynthesis in K562 human erythroleukemia cells during prolonged exposure to iron. They show that, upon addition of hemin (an efficient iron donor) to the cell culture, the rate of ferritin biosynthesis reaches a maximum after a few hours and then decreases. During a 24-hr incubation with the iron donor the concentrations of total ferritin heavy (H) and light (L) subunit mRNAs rise 2- to 5-fold and 2- to 3-fold, respectively, over the control values, while the amount of the protein increases 10- to 30-fold. The hemin-induced increment in ferritin subunit mRNA is not prevented by deferoxamine, suggesting that it is not directly mediated by chelatable iron. In vitro nuclear transcription analyses performed on nuclei isolated from control cells and cells grown in the presence of hemin indicate that the rates of synthesis of H- and L-subunit mRNAs remain constant. They conclude that iron-induced ferritin biosynthesis is governed by multiple post-transcriptional regulatory mechanisms. They propose that exposure of cells to iron leads to stabilization of ferritin mRNAs, in addition to activation and translation of stored H-and L-subunit mRNAs

76 FR 67498 - Post Office Closing

Science.gov (United States)

2011-11-01

... POSTAL REGULATORY COMMISSION [Docket No. A2012-17; Order No. 918] Post Office Closing AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: This document informs the public that an appeal of the closing of the Venice, California post office has been filed. It identifies preliminary steps and...

Changes in the volume, power and nutritional quality of foods marketed to children on television in Canada.

Science.gov (United States)

Potvin Kent, Monique; Martin, Cherie L; Kent, Emily A

2014-09-01

To evaluate the self-regulatory Children's Food and Beverage Advertising Initiative pre- and post-implementation in terms of volume of marketing, marketing techniques, and nutritional quality of foods marketed to children on television. Data for 11 food categories for May 2006 and 2011 were purchased from Nielsen Media Research for two children's specialty channels in Toronto. A content analysis of food advertisements examining the volume and marketing techniques was undertaken. Nutritional information on each advertisement was collected and comparisons were made between 2006 and 2011. The volume of ads aired by Canadian Children's Food and Beverage Advertising Initiative (CAI) companies on children's specialty channels decreased by 24% between 2006 and 2011; however, children and teens were targeted significantly more, and spokes-characters and licensed characters were used more frequently in 2011 compared to 2006. The overall nutritional quality of CAI advertisements remains unchanged between 2006 and 2011. There are clear weaknesses in the self-regulatory system in Canada. Food advertising needs to be regulated to protect the health of Canadian children. © 2014 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Marketing Communications in the Post-Advertising Era.

Science.gov (United States)

Dilenschneider, Robert L.

1991-01-01

Challenges four commonly held myths about advertising and marketing effectiveness. Establishes the framework for a more comprehensive program of marketing communication involving traditional public relations, advertising, sales promotion, special events, along with new uses for public affairs work in marketing. (MG)

Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification.

Science.gov (United States)

Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

2017-05-01

Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time. We searched electronic and non-electronic sources to identify medicinal products that were withdrawn because of drug-attributed deaths. We used a previously published algorithm to examine whether the withdrawals of products were justified. We then searched PubMed and Google Scholar to identify studies investigating the drug-adverse event relationships, used the Oxford Centre for Evidence-Based Medicine criteria to document the levels of evidence, and assessed whether the evidence of an association was confirmed. We included 83 medicinal products. The reasons for withdrawal appeared to have been justified in 80 cases (96%). The median interval between the first reported adverse reaction that was related to the cause of death and the first reported death was 1 year (interquartile range = 1-3); products were withdrawn sooner when the interval between the first reported relevant adverse reaction and the first death was shorter. Confirmatory studies were conducted in 57 instances (69%), and there was evidence of an association in 52 cases (63%). Four products (5%) were re-introduced after initial withdrawal. Regulatory authorities have been justified in making withdrawal decisions when deaths have been attributed to medicinal products, using the precautionary principle when alternative decisions

Drug development: from concept to marketing!

Science.gov (United States)

Tamimi, Nihad A M; Ellis, Peter

2009-01-01

Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for advancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safety and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product's safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright 2009 S. Karger AG, Basel.

Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

Science.gov (United States)

Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

2013-12-01

The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

Generation capacity adequacy in interdependent electricity markets

International Nuclear Information System (INIS)

Cepeda, Mauricio; Finon, Dominique

2011-01-01

This paper deals with the practical problems related to long-term security of supply in regional electricity markets with transmission constraints. Differences between regulatory policies and market designs in terms of generation adequacy policies may distort the normal functioning of the neighboring markets, as well as the reliability of supply. We test the effect of heterogeneous regulatory design between two interdependent markets: energy-only market, price-capped market without capacity mechanisms and price-capped markets with forward capacity contracts obligation. We rely on a long-term market simulation model in system dynamics that characterizes expansion decision in a competitive regime. The results show that differences in market designs affect both price and reliability of supply in the two markets. We examine both the short and long terms effect, and how free-riding may occur where capacity adequacy policies are adopted in one market but not the other. The main finding is that the lack of harmonization between local markets in policies to ensure capacity adequacy may lead to undesirable side effects. - Research highlights: → We model the long-term dynamic of two interdependent markets. → We examine both the short and long terms effect of heterogeneous regulatory design: energy-only market, price-capped market without capacity mechanisms and price-capped markets with forward capacity contracts obligation. → Differences in market designs affect both price and reliability of supply in the two markets. → Lack of harmonization between local markets in policies to ensure capacity adequacy may lead to undesirable side effects. → Free-riding may occur where capacity adequacy policies are adopted in one market but not the other.

Impact of Insurance Market on Economic Growth in Post-Transition Countries

Directory of Open Access Journals (Sweden)

Phutkaradze Jaba

2014-12-01

Full Text Available The purpose of this work is to identify whether the development of an insurance market is linked to economic growth in former transition countries. A multiple regression analysis is employed to estimate the insurance-growth relationship, using a cross-country panel dataset analysis tracking annual total insurance penetration in 10 countries over the 2000-2012 period, and applying a fixed effect model to test the hypothesis that this linkage is demonstrably positive. The results show a negative and statistically non-significant correlation between insurance and GDP growth, suggesting a lack of evidence that insurance promotes economic growth in post-transition economies.

Regional Power Integration : Structural and Regulatory Challenges

OpenAIRE

World Bank

2011-01-01

The Central America Regional Electricity Market (MER) trades electricity and transmission capacity among six Central American countries: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama. The market differs from other electricity markets worldwide because it has its own regulatory body and system operator. Economic integration of the Central American countries has followed...

The Internationalization and Market Competition of Tsai Yueh-Hsun’s Post-Confucian TV Drama and Films in East Asia

Directory of Open Access Journals (Sweden)

Jocelyn Yi-Hsuan Lai

2018-04-01

Full Text Available This essay investigates the East Asia-oriented TV and film productions of Taiwanese producer-director Tsai Yueh-hsun. His productions have made wide use of the transnational bankability of Taiwanese TV stars. Set in nationally non-specific urban societies, they are categorized as post-Confucian TV dramas, adopting liberal Western values and presenting problems in the authoritative patriarchal culture of the modern yet Confucian East Asia. They have competed in this market with neo-Confucian Korean and mainland Chinese TV dramas that follow Confucian patriarchal values. His productions in the 2000s entered many East Asian markets, including Southeast Asian countries, Japan, and mainland China, with the latter airing censored versions. In the 2010s, his productions have prioritized the rapidly increasing mainland Chinese market among all East Asian markets and adopted Taiwanese-mainland Chinese cooperation. The productions maintain the post-Confucian style of presentation, but remove the political viewpoint commonly perceived in Taiwan. Confronted with Taiwanese skepticism toward the Taiwanese-mainland Chinese cooperation, Tsai argues that this strategy will contribute to the development of Taiwan’s film and TV industry. The presentation of Taiwan’s modern places in the productions will help promote its tourism.

75 FR 17174 - Market Test

Science.gov (United States)

2010-04-05

... POSTAL REGULATORY COMMISSION [Docket No. MT2010-1; Order No. 434] Market Test AGENCY: Postal... notice announcing its intent to initiate a market test. This notice addresses procedural steps associated... intent to initiate a market test beginning on or about May 1, 2010, of an experimental competitive...

Regulatory pathways for vaccines for developing countries.

Science.gov (United States)

Milstien, Julie; Belgharbi, Lahouari

2004-01-01

Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

International Nuclear Information System (INIS)

Zhu, Xiao; Kruhlak, Naomi L.

2014-01-01

Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

Science.gov (United States)

Grignolo, Alberto; Mingping, Zhang

2018-01-01

Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.

Uranium and nuclear market, the horizon post-Fukushima

International Nuclear Information System (INIS)

Lelièvre, F.

2014-01-01

Post-Fukushima, most countries have confirmed the importance of nuclear in their energy mix. We are seeing a level of new reactor construction unparalleled in decades with 61 nuclear power plants under construction and 5 plants under completion around the world. Global nuclear capacity is expected to increase by 50% over the next two decades. And more reactors mean more demand for uranium. However, uranium industry is currently grappling with near-term challenges, particularly in the form of depressed uranium prices. Recently several uranium producers announced production delays or cancellations in response to low prices, including major suppliers. As the current price levels, including long-term prices, are not sufficient to stimulate new production, future supplies are in question due to the long-lead nature of uranium mine development. Despite the near- to medium-term issues of our industry, the fundamentals of the uranium market remain strong over the long term - and these are the drivers of the Areva’s mining growth strategy over the coming years. (author)

Applications of pharmacogenomics in regulatory science: a product life cycle review.

Science.gov (United States)

Tan-Koi, W C; Leow, P C; Teo, Y Y

2018-05-22

With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

Science.gov (United States)

Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

2010-01-01

The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

Liberalisation of the EU gas market. Lessons learned from other markets and countries

International Nuclear Information System (INIS)

Bisgaard, T.

2003-11-01

In this report the EU's Gas Directive 2003/55/EC is evaluated to determine whether it lays an adequate regulatory foundation to create and enhance a future competitive gas market in Europe; at national level as well as across borders. The aim is to enable the gas market to become an integrated part of the European single market. Experiences are drawn upon from the electricity and telecom markets, and from the UK and the US, that have undergone similar liberalisation processes. A market in transition from a monopoly to a liberalised market should be subject to a certain kind of regulation that is not applicable to other markets. The regulation must be designed in a way that gives the market room for development. The evaluation in this report is based on four requirements deemed important by the OECD for a changing market like the gas market. The four requirements that should be considered when regulating the gas market are: 1. Third party access to infrastructure, 2. The degree of un-bundling, 3. The regulation of tariffs, and 4. The type of regulatory authority to oversee the gas market. The report concludes that the Gas Directive provides sufficient regulation for creating competition in the national gas markets, but that it is vital to provide legislation that will harmonise rules across Europe and create the appropriate incentives for future investments in the gas structure. (BA)

Regulatory inhibition of biological tissue mineralization by calcium phosphate through post-nucleation shielding by fetuin-A

Energy Technology Data Exchange (ETDEWEB)

Chang, Joshua C., E-mail: joshchang@ucla.edu [Clinical Center, National Institutes of Health, Bethesda, Maryland 20892, USA and Mathematical Biosciences Institute, The Ohio State University, Columbus, Ohio 43210 (United States); Miura, Robert M., E-mail: miura@njit.edu [Department of Mathematical Sciences, New Jersey Institute of Technology, Newark, New Jersey 07102 (United States)

2016-04-21

In vertebrates, insufficient availability of calcium and inorganic phosphate ions in extracellular fluids leads to loss of bone density and neuronal hyper-excitability. To counteract this problem, calcium ions are usually present at high concentrations throughout bodily fluids—at concentrations exceeding the saturation point. This condition leads to the opposite situation where unwanted mineral sedimentation may occur. Remarkably, ectopic or out-of-place sedimentation into soft tissues is rare, in spite of the thermodynamic driving factors. This fortunate fact is due to the presence of auto-regulatory proteins that are found in abundance in bodily fluids. Yet, many important inflammatory disorders such as atherosclerosis and osteoarthritis are associated with this undesired calcification. Hence, it is important to gain an understanding of the regulatory process and the conditions under which it can go awry. In this manuscript, we extend mean-field continuum classical nucleation theory of the growth of clusters to encompass surface shielding. We use this formulation to study the regulation of sedimentation of calcium phosphate salts in biological tissues through the mechanism of post-nuclear shielding of nascent mineral particles by binding proteins. We develop a mathematical description of this phenomenon using a countable system of hyperbolic partial differential equations. A critical concentration of regulatory protein is identified as a function of the physical parameters that describe the system.

The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

Science.gov (United States)

Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

2018-04-20

A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

The Regulatory Consumer: Prosumer-Driven Local Energy Production Initiatives

NARCIS (Netherlands)

Butenko, A.; Cseres, K.

2015-01-01

This paper analyzes the (pro)active role consumers could (and are encouraged by the respective policy to) assume in markets that emerged due to European market liberalization and technological changes. These changes expanded consumer markets and changed regulatory architectures accordingly.

The interplay between societal concerns and the regulatory frame on GM crops in the European Union.

Science.gov (United States)

Devos, Yann; Reheul, Dirk; De Waele, Danny; Van Speybroeck, Linda

2006-01-01

Recapitulating how genetic modification technology and its agro-food products aroused strong societal opposition in the European Union, this paper demonstrates how this opposition contributed to shape the European regulatory frame on GM crops. More specifically, it describes how this opposition contributed to a de facto moratorium on the commercialization of new GM crop events in the end of the nineties. From this period onwards, the regulatory frame has been continuously revised in order to slow down further erosion of public and market confidence. Various scientific and technical reforms were made to meet societal concerns relating to the safety of GM crops. In this context, the precautionary principle, environmental post-market monitoring and traceability were adopted as ways to cope with scientific uncertainties. Labeling, traceability, co-existence and public information were installed in an attempt to meet the general public request for more information about GM agro-food products, and the specific demand to respect the consumers' and farmers' freedom of choice. Despite these efforts, today, the explicit role of public participation and/or ethical consultation during authorization procedures is at best minimal. Moreover, no legal room was created to progress to an integral sustainability evaluation during market procedures. It remains to be seen whether the recent policy shift towards greater transparency about value judgments, plural viewpoints and scientific uncertainties will be one step forward in integrating ethical concerns more explicitly in risk analysis. As such, the regulatory frame stands open for further interpretation, reflecting in various degrees a continued interplay with societal concerns relating to GM agro-food products. In this regard, both societal concerns and diversely interpreted regulatory criteria can be inferred as signaling a request - and even a quest - to render more explicit the broader-than-scientific dimension of the actual

Decoupling the Oil and Gas Prices. Natural Gas Pricing in the Post-Financial Crisis Market

International Nuclear Information System (INIS)

Kanai, Miharu

2011-01-01

This paper looks into natural gas pricing in the post-financial crisis market and, in particular, examines the question whether the oil-linked gas pricing system has outlived its utility as global gas markets mature and converge more rapidly than expected and as large new resources of unconventional gas shift the gas terms-of-trade. Two opposing natural gas pricing systems have coexisted for the last two decades. On the one hand, there is traditional oil-linked pricing, used in pipeline gas imports by Continental European countries and in LNG imports by the countries in Far East. The other is the system led by futures exchanges in deregulated, competitive markets largely in the UK and the US. World gas markets are changing and the basis and mechanisms of price formation are changing with them. There is no reason to expect a revolution in gas pricing, but formulas designed to address the challenges of the 1970's will need to adjust to the realities of the present and expectations for the 21. century. Because such changes will imply a redistribution of costs and benefits, vested shareholders will defend the status quo. But hopefully and ultimately, appropriately regulated markets will assert themselves and shareholders along the entire value chain will have their interests served

Volume Shocks around Announcements in the Chinese Stock Market: An Ex-Post Earnings-Information-Based Study of Speculative Behavior

Directory of Open Access Journals (Sweden)

Xiangdong Chen

2017-09-01

Full Text Available The Second Board Market is typical stock market for high tech companies in China. This paper discusses the relationship between trading volume and price changes in the case of high-tech listed companies in the Chinese Second-Board Stock Market. By using the basic concepts proposed by Kim and Verrecchia, and Kandel and Pearson, and contrasting them with ex-post information from earnings releases, the paper provides findings on the speculative behavior of informed traders with a volume shock premium. The paper suggests that these methods may be further applied to investigating investors’ behavior in speculation, especially for the high-tech-company-based Second-Board Stock Market during announcement periods.

Analysis of competition and market power in the wholesale electricity market in India

International Nuclear Information System (INIS)

Shukla, Umesh Kumar; Thampy, Ashok

2011-01-01

The electricity reforms were initiated in India with the objective of promoting competition in the electricity market. In order to promote competition, the Electricity Act 2003 was enacted and various policy initiatives were taken by the Government of India. Central Electricity Regulatory Commission (CERC) also facilitated competition through the regulatory framework of availability based tariff, Indian Electricity Grid Code, open access in inter-state transmission, inter-state trading and power exchanges. Despite these initiatives, electricity prices increased in the Wholesale Electricity Market in India (WEMI). This paper analyses the market structure and competitiveness in the WEMI. There are, of course, various potential reasons for the rise in the electricity price. This paper seeks to investigate, if market power was one of the reasons for increase in market prices. Concentration ratio, Herfindahl-Hirschman index, Supply Margin Assessment, and Residual Supply Index have been used to measure market power. This paper also uses the price-cost mark-up to examine, if exercise of market power led to higher margins. The analysis suggests that market power of firms may be part of the reason for the increase in electricity prices in WEMI. The study suggests various measures to increase competition in the WEMI.

[Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

Science.gov (United States)

Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

2011-10-01

To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

Highlights of the EPA innovative regulatory strategies workshop: Market-based incentives and other innovations for air pollution control. Summary of workshop discussion sessions. Held in Washington, DC on January 15-17, 1992

International Nuclear Information System (INIS)

1992-06-01

The Clean Air Act Amendments of 1990 allow, and in some cases require, States to adopt market-based strategies or other innovative types of air pollution control. The U.S. Environmental Protection Agency's (EPA's) innovative regulatory strategies program seeks to encourage and facilitate, as appropriate, the development, demonstration, and implementation of a wide range of innovative regulatory air pollution programs, including market-based, informational, and pollution prevention approaches. The 3-day national workshop, attended by over two hundred people from Federal, State, and local agencies, industry, environmental and public interest groups, and the academic community highlighted issues associated with a variety of innovative, market-based strategies which are currently being developed or used by State and local authorities around the country

Market, Regulation, Market, Regulation

DEFF Research Database (Denmark)

Frankel, Christian; Galland, Jean-Pierre

2015-01-01

barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had......This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical...... alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned...

Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

Science.gov (United States)

Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

2013-01-11

China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

MARKET WATCH

Institute of Scientific and Technical Information of China (English)

无

2010-01-01

TO THE POINT:The government vows to control the real estate market after a year of robust growth.To diversify financial investment tools,the regulatory authorities approved the launch of stock index futures,and short selling and margin trading to allow investors to hedge against risks.China overtakes the United States to become the world’s biggest auto market in2009.The country is also expected to become the largest consumer market in the world by2020.Google threatens to halt its China operations if it cannot reach a censorship agreement with the government.

Advisory report on licence requirements for the marketing of natural gas and electricity to residential and small commercial consumers

International Nuclear Information System (INIS)

1998-01-01

The proposed Ontario Energy Board Act, 1998 which forms part of Bill 35, would make it possible for the Board to make regulations prescribing license requirements and conditions for sellers of natural gas and electricity to residential and small commercial users. Interested stakeholders were invited to provide their input on the proposed Act. A total of 23 parties responded by submitting their comments to the Ontario Energy Board. This document presents the concerns of several parties regarding various provisions of the proposed regulatory regime affecting energy marketing. Comments on the definition of 'low volume customer', on classes of gas marketers, need and requirements for gas marketer's licence, the form and posting of security bonds by prospective gas marketers, exemptions from licensing, conditions of licensing, code of conduct for energy marketers, disclosure of customer information, were some of the proposed provisions that elicited comments

Characteristics of regulatory regimes

Directory of Open Access Journals (Sweden)

Noralv Veggeland

2013-03-01

Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

Regionalism versus integration of the EU electricity market : An open debate from the comparative and prospective analysis of regulatory regimes in the central European countries

Energy Technology Data Exchange (ETDEWEB)

Engoian, Alda; Mouchart, Christel

2005-12-15

The failure of integration of 25 national energy markets into an unique one has been clearly expressed by the European Commission in its last benchmarking report. This working paper investigate the question of the more appropriate and realistic market design to limit perverse effects linked to the gaps between Western and Eastern European electricity markets. The paper consists in comparing electricity regulations per segment of the value chain in the CECs (Czech Republic, Hungary, Poland, Slovakia) characterized by industrial structures stemming from the socialism. Our regulatory approach and the example of South-East Europe support the idea of regionalism as an interim stage towards a final integrated European market. This regionalism based on the Standard Market Design concept, with flexible principles, and simultaneously combined to national reforms would seem to be a ''key of success''. (Author)

Regionalism versus integration of the EU electricity market : An open debate from the comparative and prospective analysis of regulatory regimes in the central European countries

International Nuclear Information System (INIS)

Engoian, Alda; Mouchart, Christel

2005-01-01

The failure of integration of 25 national energy markets into an unique one has been clearly expressed by the European Commission in its last benchmarking report. This working paper investigate the question of the more appropriate and realistic market design to limit perverse effects linked to the gaps between Western and Eastern European electricity markets. The paper consists in comparing electricity regulations per segment of the value chain in the CECs (Czech Republic, Hungary, Poland, Slovakia) characterized by industrial structures stemming from the socialism. Our regulatory approach and the example of South-East Europe support the idea of regionalism as an interim stage towards a final integrated European market. This regionalism based on the Standard Market Design concept, with flexible principles, and simultaneously combined to national reforms would seem to be a ''key of success''. (Author)

Advisory report on licence requirements for the marketing of natural gas and electricity to residential and small commercial consumers

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-10-06

The proposed Ontario Energy Board Act, 1998 which forms part of Bill 35, would make it possible for the Board to make regulations prescribing license requirements and conditions for sellers of natural gas and electricity to residential and small commercial users. Interested stakeholders were invited to provide their input on the proposed Act. A total of 23 parties responded by submitting their comments to the Ontario Energy Board. This document presents the concerns of several parties regarding various provisions of the proposed regulatory regime affecting energy marketing. Comments on the definition of `low volume customer`, on classes of gas marketers, need and requirements for gas marketer`s licence, the form and posting of security bonds by prospective gas marketers, exemptions from licensing, conditions of licensing, code of conduct for energy marketers, disclosure of customer information, were some of the proposed provisions that elicited comments.

Natural gas marketing II

International Nuclear Information System (INIS)

Anon.

1988-01-01

This book covers all aspects of gas marketing, from the basic regulatory structure to the latest developments in negotiating agreements and locating markets. Topics include: Federal regulation of the gas industry; Fundamentals of gas marketing contracts; FERC actions encouraging competitive markets; Marketing conditions from the pipelines' perspective; State non-utility regulation of natural gas production, transportation, and marketing; Natural gas wellhead agreements and tariffs; Natural gas processing agreements; Effective management of producer's natural gas contracts; Producer-pipeline litigation; Natural gas purchasing from the perspective of industrial gas users; Gas marketing by co-owners: problems of disproportionate sales, gas balancing, and accounting to royalty owners; Alternatives and new directions in marketing

Public health implications of differences in U.S. and European Union regulatory policies for breast implants.

Science.gov (United States)

Zuckerman, Diana; Booker, Nyedra; Nagda, Sonia

2012-12-01

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (U.S.) and European Union (EU). In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the U.S. than in the EU, a decision U.S. government health agencies can point to with pride. Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Regulation of Banking and Financial Markets

NARCIS (Netherlands)

A.M. Pacces (Alessio); D. Heremans (Dirk)

2011-01-01

textabstractAbstract: This paper is one chapter of the volume “Regulation and Economics” of the second edition of the Encyclopedia of Law and Economics. The authors review the economics of banking and financial markets and the regulatory response to market failure. Market failure in finance depends

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Industry

Science.gov (United States)

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary brings together the relevant key findings for industry from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and training (VET) and…

Islamic Financial Engineering : Comparative Study Agreements in Islamic Capital Market in Malaysia and Indonesia

Directory of Open Access Journals (Sweden)

Adhitya Ginanjar

2014-03-01

Full Text Available Objective –The objective of this paper is to provide a discussion Islamic Financial Engineering which practice between Indonesian Capital Market and Malaysian capital market. This paper also investigate whether regulator could effectively take a role in materializing demands for Islamic securities and whether regulator declaration is more convincing than sharia compliance declaration between IDX and KLSE.Methods - We use descriptive analytic and literature study to see the background, market response caused by regulatory for Islamic Financial Engineering. We also analyze Islamic capital market regulatory from middle east countries.Results - We find that Islamic Capital Market in KLSE (Malaysian Capital Market more higher growth than IDX (Indonesia Capital Market because of Islamic Capital Regulatory in KLSE much easier to improve Islamic Financial Engineering from conventional schemes.Conclusion - This finding could explain why Islamic Capital Market in KLSE is still growing rapidly and IDX will adjust their Islamic Capital Market Regulatory to compete with regional Islamic Capital Market.Keywords : Islamic Financial Engineering, Risk, Return, Derivative, Hedging, Option, Forward, Hybrid  contract

Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

Science.gov (United States)

Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

2013-10-10

Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

Science.gov (United States)

Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

2009-12-01

The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

Results of a customer-based, post-market surveillance survey of the HeRO access device.

Science.gov (United States)

Fusselman, Maureen

2010-08-01

In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

Learning by the Market: Regulatory Regionalism, Bologna, and Accountability Communities

Science.gov (United States)

Jayasuriya, Kanishka

2010-01-01

Over the last two decades institutions of higher education have been subject to new modes of regulatory governance. This essay applies a "regulatory lens" to higher education governance with a view to understanding the sometimes contradictory relationship between the globalisation and regionalisation of higher education and the…

United States natural gas markets, contracts and risks: What lessons for the European Union and Asia-Pacific natural gas markets?

International Nuclear Information System (INIS)

Talus, Kim

2014-01-01

The article examines the natural gas markets of the United States, the European Union and the Asia-Pacific region and their regulation and contractual structures. The article's main focus is on the United States natural gas markets. The European Union and Asia-Pacific markets are compared to this more developed market. By comparing the physical and ideological characteristics of, and differences between, the three main international gas markets, the article exposes the limits of regulatory and contractual transplants in this area of law and policy. Each of these markets is unique, which limits the opportunities for modelling certain market institutions on the basis of the more developed markets in the United States. This applies for both the EU and the Asia-Pacific region. - Highlights: • Differences in the physical markets impact regulation. • Regulatory transplants have risks. • The approach in energy policy should be based on “Law-in-Context” approach

The climate impacts of bioenergy systems depend on market and regulatory policy contexts.

Science.gov (United States)

Lemoine, Derek M; Plevin, Richard J; Cohn, Avery S; Jones, Andrew D; Brandt, Adam R; Vergara, Sintana E; Kammen, Daniel M

2010-10-01

Biomass can help reduce greenhouse gas (GHG) emissions by displacing petroleum in the transportation sector, by displacing fossil-based electricity, and by sequestering atmospheric carbon. Which use mitigates the most emissions depends on market and regulatory contexts outside the scope of attributional life cycle assessments. We show that bioelectricity's advantage over liquid biofuels depends on the GHG intensity of the electricity displaced. Bioelectricity that displaces coal-fired electricity could reduce GHG emissions, but bioelectricity that displaces wind electricity could increase GHG emissions. The electricity displaced depends upon existing infrastructure and policies affecting the electric grid. These findings demonstrate how model assumptions about whether the vehicle fleet and bioenergy use are fixed or free parameters constrain the policy questions an analysis can inform. Our bioenergy life cycle assessment can inform questions about a bioenergy mandate's optimal allocation between liquid fuels and electricity generation, but questions about the optimal level of bioenergy use require analyses with different assumptions about fixed and free parameters.

Panorama 2010: CO2 markets and the current status of international climate negotiations

International Nuclear Information System (INIS)

Alberola, E.

2010-01-01

The emission of greenhouse gases (GHGs) to the atmosphere is causing climatic disturbances of increasing severity, representing risks for the entire planet. Existing GHG emissions reduction policies mainly focus on setting up cap and trade systems (carbon markets) geared to achieving such reductions. The Kyoto Protocol, an international treaty established under the auspices of the United Nations, sets forth the guiding principles, objectives and legally binding targets imposed on the parties concerned until 2012. The purpose of the international negotiations underway is to set up a new regulatory framework for the post-2012 period. (author)

Adoption Space and the Idea-to-Market Process of Health Technologies.

Science.gov (United States)

Saranummi, Niilo; Beuscart, Regis; Black, Norman; Maglaveras, Nicos; Strano, Chiara; Karavidopoulou, Youla

2016-01-01

Although Europe 'produces' excellent science, it has not been equally successful in translating scientific results into commercially successful companies in spite of European and national efforts invested in supporting the translation process. The Idea-to-Market process is highly complex due to the large number of actors and stakeholders. ITECH was launched to propose recommendations which would accelerate the Idea-to-Market process of health technologies leading to improvements in the competitiveness of the European health technology industry in the global markets. The project went through the following steps: defining the Idea-to-Market process model; collection and analysis of funding opportunities; identification of 12 gaps and barriers in the Idea-to-Market process; a detailed analysis of these supported by interviews; a prioritization process to select the most important issues; construction of roadmaps for the prioritized issues; and finally generating recommendations and associated action plans. Seven issues were classified as in need of actions. Three of these are part of the ongoing Medical Device Directive Reform (MDR), namely health technology assessment, post-market surveillance and regulatory process, and therefore not within the scope of ITECH. Recommendations were made for eHealth taxonomy; Education and training; Clinical trials and Adoption space and Human Factors Engineering (HFE).

Technology mix configuration in liberalized electricity market

International Nuclear Information System (INIS)

Castro-Rodriguez, F.

2007-01-01

This paper analyzes the evolution of technology mix in the electricity industry when investment choices are left to private investors. In particular, possible failures and investment biases in recent liberalized electricity markets are presented. In addition, the main regulatory mechanisms used in practice and their effects are analyzed. Finally, this paper explores the government intervention in technology choices in the Spanish electricity market from the beginning of the liberalization process. While some regulatory rules have adequacy complemented the market functioning, others have distorted the electricity price, which is the reference to signal right investments. (Author) 13 refs

The impact of regulatory obligations on fishers’ income

DEFF Research Database (Denmark)

Hadjimichael, Maria; J. Kaiser, Michel; Edwards-Jones, Gareth

2013-01-01

as a marketing tool to identify fishers’ most and least preferred regulatory obligations in terms of the impact these obligations have on their income. Significant differences were identified in fishers’ preferences that depended on the regulatory measures fishers operated under at the time of the study (which...

From Funding Liquidity to Market Liquidity

DEFF Research Database (Denmark)

Dick-Nielsen, Jens; Lund, Jesper; Gyntelberg, Jacob

This paper shows empirically that funding liquidity drives market liquidity. As it becomes harder to secure term funding in the money markets, liquidity deteriorates in the Danish bond market. We show that the first principal component of bond market liquidity is driven by the market makers...... for other European government bonds using MTS data. The findings suggest that regulatory bond based liquidity buffers for banks will have limited effectiveness....

Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

Science.gov (United States)

Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

2015-06-01

Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

Self-regulation in securities markets

OpenAIRE

Carson, John

2011-01-01

This paper canvasses the trends in self-regulation and the role of self-regulation in securities markets in different parts of the world. The paper also describes the conditions in which self-regulation might be an effective element of securities markets regulation, particularly in emerging markets. Use of self-regulation and self-regulatory organizations is often recommended in emerging m...

Regulatory principles to enhance coherence and to facilitate trade in wine

Directory of Open Access Journals (Sweden)

Hodson Greg

2014-01-01

Full Text Available The globalization of the wine market has generally outpaced regulatory development. As a result, wine has been introduced to markets with little historical product experience and has been subjected to standard food regulatory approaches that are not always appropriate given its unique characteristics. In addition, disparate regulatory limits and approaches to testing wine in different markets may result in inadvertent obstacles to trade and increased costs of doing business, but provide no counterbalancing benefits to consumers, producers or regulators. This paper presents a series of principles (already endorsed by FIVS that, if recognized and implemented widely by governments, would have enormous consequences for the facilitation of global trade in wine. Many of these are already being applied among established trading partners, though they are generally not stated explicitly.

Modelling the impact of market interventions on the strategic evolution of electricity markets

International Nuclear Information System (INIS)

Bunn, Derek W.; Oliveira, Fernando S.

2005-01-01

In this paper, we seek to develop some model-based insights into this two-stage dynamic process linking market interventions with individual company performance through strategic asset trading and structural change. Essentially, this is achieved with an evolutionary, agent-based, computational model that is capable of simulating how a Cournot player, by interacting with his opponents, can rationally adapt his generation portfolio in order to increase value. The functional capabilities of the proposed computational approach facilitate: 1) The study of asset portfolio adaptation as a result of rational choice. This cannot be achieved with a static Cournot model that, by construction, does not take into account endogenously the rational choice of the installed capacities and technologies used by the players. Further, this evolutionary computational model internalizes the ''path dependencies'' as one of the determinants of portfolio adaptation. 2) The analysis of market structure as an endogenous co-evolutionary process, enabling an adaptive view of the impact of short-term regulatory policies on the evolution of the industry's market structure. 3) The analysis of the behavioural implications f the rational adaptation of players to regulatory interventions. This analysis is carried-out by modelling how players trade their assets in order to improve the value of their portfolio. Our model therefore incorporates two main components: a plant trading game and an electricity market game. The plant trading game simulates the interaction between electricity companies that trade generation plants. The electricity market game simulates the performance of portfolios of plant in an electricity market assuming Cournot players. From this two-stage modelling platform, we analyze two sorts of anti-trust interventions: (a) the ''structural changes'' of enforced divestiture and (b) the ''behavioural remedies'' (sic Competition commission) of capacity availability requirements. We have

Capacity investment and competition in decentralized electricity markets

Energy Technology Data Exchange (ETDEWEB)

Fehr, Nils-Henrik von der; Harbord, David Cameron

1997-11-01

With particular reference to the recently deregulated and market-based electricity industries in Norway, the UK and elsewhere the report analyses oligopoly entry and capacity investment decisions as a non-cooperative game in a decentralized electricity market. A two-stage game is considered, with multiple capacity types and uncertain demand, in which capacity decisions are made prior to spot-market, or price competition. Equilibrium outcomes for different pricing mechanisms or regulatory regimes are analysed. The following questions are dealt with in particular: Will industry capacity be sufficient to ensure adequate supply security? Does imperfect competition in the spot-market lead to an inefficient mix of base-load and peak-load technologies? How do different regulatory policies affect the market outcomes? 24 refs., 2 figs., 1 tab.

Linking Entrepreneurial Orientation to Firm Performance in a Post-Socialist Market Context: the Case of Hungary

Directory of Open Access Journals (Sweden)

David KOVACS

2016-12-01

Full Text Available Entrepreneurial orientation provoked the interest of numerous scholars as well as political and administrative decision-makers. Both start-ups and already established corporate entities are increasingly persecuting new opportunities, products, and business models in order to establish superiority above their competitive environment. The tendencies evince an optimist impact of entrepreneurial orientation on business performance, namely on financial performance. Beyond the aforementioned relationship, there are impulses such as environmental and organizational factors, which are affecting the businesses. The results of this study provide evidence of the effect of entrepreneurial orientation on business performance in a post-socialist context. We test the impact of three moderators on this bivariate relationship. In contrast to the substantial body of literature for Western markets, we contribute to minimizing the considerable gap of research in post-socialist economies. Entrepreneurial orientation as an organizational behavior may affect the financial performance of businesses differently in distinct market contexts. Both, internal and external factors are crucial to identifying, analyze and monitor, to achieve superior performance and to overcome competitors. This study builds upon a stratified sampling survey of Hungarian company owners and managers from the Amadeus database. The study uses a deductive approach. For the analysis, we rely on structural equation modeling using the PLS algorithm. Our study contributes to the existing literature by means of confirming the entrepreneurial orientation to firm performance relationship for Hungary. In this context, we test the moderating effects of environmental dynamism, environmental hostility as environmental factors and firm age as an organizational factor. Environmental hostility is closely related to an unfavorable environment, deriving from rapid and radical changes in the industry, which are

Reliability of supply in competitive electricity markets: The Nordic electricity Market

International Nuclear Information System (INIS)

Singh, Balbir

2005-12-01

An overview of the current regulation and performance of the network utilities with respect to the reliability of supply across Europe in general indicates wide variation. On the regional level the situation in the Nordic market is no exception. Can the variation in reliability of supply in Nordic region be explained by differences in regulatory frameworks in the Nordic countries and is it possible to draw any best practice lessons for other countries and regions? The Norwegian regulation and performance with respect to reliability criterion is encouraging, however it must be emphasized that the Norwegian experience with reliability regulation in its current form covers a period of 3 years, a period that is too short to evaluate the Norwegian model. A closer examination of the Norwegian model reveals dynamic trade off in reliability performance, which if permanent may endanger the reliability of supply in the long-run. Last, but not the least important is the criterion that choice of regulation should be based on a careful social cost-benefit analysis of the regulatory model where both cost incurred by the regulatory agencies and the compliance costs incurred by the regulated utilities are included. A preliminary analysis of regulatory agencies in the Nordic market indicates that Norwegian model of network regulation is quite resource incentive. While it is premature to draw conclusions about the national regulatory mechanisms, the Nordic cross border regulation through voluntary arrangements under the auspices of NORDEL provides a good example of an arrangement that is useful when implementation of a formal regulatory regime across different jurisdiction is not possible

13 CFR 108.585 - Voluntary decrease in NMVC Company's Regulatory Capital.

Science.gov (United States)

2010-01-01

...'s Regulatory Capital. 108.585 Section 108.585 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Managing the Operations of a NMVC Company Voluntary Decrease in Regulatory Capital § 108.585 Voluntary decrease in NMVC Company's Regulatory Capital. You must...

Integration of Financial Markets in Post Global Financial Crises and Implications for British Financial Sector: Analysis Based on A Panel VAR Model

OpenAIRE

Nasir, M; Du, M

2017-01-01

This study analyses the dynamics of integration among global financial markets in the context of Global Financial Crisis (2008) by employing a Panel Vector Autoregressive (VAR) model on the monthly data of nine countries and three markets from Jan 2003 to Oct 2015. It was found that there has been a shift in the association among the global financial markets since Global Financial Crisis (GFC).Moreover, the British financial sectors in Post-GFC world clearly showed a change in the association...

Situational Marketing: Application for Higher Education Institutions.

Science.gov (United States)

Taylor, Raymond E.; Reed, Rosetta R.

1995-01-01

Marketing higher education has been criticized for its consumer (interpreted as student) orientation. An alternative concept, situational marketing, considers the student as one of a number of environmental forces on which the marketing mix focuses. Other forces include funding and regulatory agencies, businesses, alumni, faculty, parents, the…

18 CFR 284.503 - Market-power determination.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Market-power determination. 284.503 Section 284.503 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... RELATED AUTHORITIES Applications for Market-Based Rates for Storage § 284.503 Market-power determination...

[Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

Science.gov (United States)

Li, Yuanyuan; Xie, Yanming

2011-10-01

The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

Do marketing and alcohol treatment/public health experts think televised alcohol advertisements abide by regulatory guidelines?

Science.gov (United States)

Lloyd, Kelly; Cameron, Elaine; Williams, Hannah; Banister, Emma; Donmall, Michael; Higgins, Alan; French, David P

2018-04-01

Televised alcohol advertisements in the United Kingdom must abide by the Broadcast Committee of Advertising Practice Code, which provides guidelines concerning advertisements not implying, condoning or encouraging immoderate, irresponsible or antisocial drinking. Previously, 75 per cent of 373 general public respondents were shown one of seven advertisements rated a breach of at least one guideline. This study assessed whether experts in marketing ( n = 25) and alcohol treatment/public health ( n = 25) perceived the same seven television alcohol advertisements as complying with the Broadcast Committee of Advertising Practice Code. Overall, 83 per cent of advertisements were rated as breaching at least one guideline. This provides further proof that self-regulatory alcohol guidelines are not fit for purpose.

How can cardiothoracic and vascular medical devices stay in the market?

Science.gov (United States)

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

78 FR 38739 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

Science.gov (United States)

2013-06-27

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0299] Standard Format and Content for Post-Shutdown Decommissioning Activities Report AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance..., ``Standard Format and Content for Post-shutdown Decommissioning Activities Report.'' This guide describes a...

2013 Bioenergy Market Report

Energy Technology Data Exchange (ETDEWEB)

Schwab, Amy [National Renewable Energy Lab. (NREL), Golden, CO (United States); Moriarty, Kristi [National Renewable Energy Lab. (NREL), Golden, CO (United States); Milbrandt, Anelia [National Renewable Energy Lab. (NREL), Golden, CO (United States); Geiger, Jesse [National Renewable Energy Lab. (NREL), Golden, CO (United States); Lewis, John [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2016-03-28

This report provides a status of the markets and technology development involved in growing a domestic bioenergy economy as it existed at the end of 2013. It compiles and integrates information to provide a snapshot of the current state and historical trends influencing the development of bioenergy markets. This information is intended for policy-makers as well as technology developers and investors tracking bioenergy developments. It also highlights some of the key energy and regulatory drivers of bioenergy markets.

Market-based approach to financial architecture

NARCIS (Netherlands)

Underhill, G.R.D.; Caprio, G.; Beck, T.; Claessens, S.; Schmukler, S.L.

2013-01-01

The institutions of financial governance are central to the prospects for financial stability. Without sound regulatory and supervisory institutions, herd behavior and market failure looms large in a liberal financial system. Cross-border and cross-sectoral financial market integration exacerbates

Regulatory problems relating to energy in Hungary

International Nuclear Information System (INIS)

Remenyi, K.

2002-01-01

One of basic problems of the transition in the energy economy is, how far the process of liberalisation and privatisation could go, i.e. to what extent the control of state/government would be given up, and how the breakdown of the commanding positions of the government would be managed. The transition in the energy sector toward a market economy is characterised by restructuring the regulatory framework of the energy industry, changing the operational structure of the sector and profound reshaping of ownership structures of the enterprises. In Hungary the government, being convinced of the importance of the implementation of the market forces, in 1991 made the first step on the way of restructuring the energy sector in order to increase economic efficiency, to enable companies to react to market forces and to privatise them. Parallel and partly after the restructuring, a profound modification of legal and regulatory framework took place and finally a relatively large scale of privatisation has newly emerged, which will continue in future, too. The process of the energy sector liberalisation in Hungary has a stop and go character and the game is not over. The process can be characterised by institutional restructuring in the energy sector (coal, oil/gas, power ), which is the basic condition for market liberalisation and privatisation, and by the creation of an appropriate environment (regulatory framework, pricing policy, etc. ) for the smooth implementation of the liberation process(author)

[Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

Science.gov (United States)

Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

2011-10-01

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

Using Research Case Studies in eCommerce Marketing Courses: Customer Satisfaction at Point-of-Purchase and Post-Purchase

Science.gov (United States)

Nawi, Noorshella Che; Fong, Michelle; Tatnall, Arthur

2014-01-01

This paper describes a research case study of Internet apparel marketing by small businesses in Malaysia which can beneficially be included in postgraduate business courses for understanding the importance of measuring customer satisfaction at point-of-purchase and post-purchase in online purchases. The sample size in this research is 154…

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

Science.gov (United States)

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

Ontario regulatory update

International Nuclear Information System (INIS)

Thompson, P.

1998-01-01

This paper provides a summary of recent events which when combined add up to a gradual but unmistakable movement of the energy sector in Ontario towards a fully competitive market. Some of the events precipitating this movement towards competition include the passing of the Energy Competition Act of 1998 (Bill 35), electricity deregulation, regulatory reform of the natural gas sector, and changes to the consumer protection legislation. The role of the Ontario Energy Board was also updated to bring it in line with the demands of the competitive marketplace. Among the new roles that the Board will assume are to facilitate competition, to maintain fair and reasonable rates, and to facilitate rational expansion. Another objective is to provide opportunities for including energy efficiency in government policies. Implications of the changes in the OEB's mandate for market participants were also discussed, including (1) regulated gas sales and delivery mechanisms, (2) transactional services, (3) contract restructuring, (4) consumer protection, (5) supervision of competitive market participants, and (6) market surveillance

18 CFR 35.41 - Market behavior rules.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Market behavior rules. 35.41 Section 35.41 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION... Sales of Electric Energy, Capacity and Ancillary Services at Market-Based Rates § 35.41 Market behavior...

Use of carabids for the post-market environmental monitoring of genetically modified crops

Czech Academy of Sciences Publication Activity Database

Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

2017-01-01

Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

Market redesign and regulatory change : how companies doing business in Alberta's power markets will be affected

International Nuclear Information System (INIS)

Runge, C.

2003-01-01

The Power Pool of Alberta (PPA) began its operations in 1996 based on a model with a single price set based on day ahead offers/bids and real time dispatch. The Electric Utilities Act was amended in 1998 and direct sales were permitted in 1999. The Power Purchase Arrangement Auction was implemented in 2000. Significant events took place in 2001, including: (1) retail competition, (2) PPAs began operations, (3) restrictions on direct sales were removed, (4) forward exchange operation, and (5) ancillary services market. In 2002, the Market Achievement Plan II was implemented and government industry structure was reviewed. There are several considerations regarding market redesign, such as day ahead market, capacity market, congestion management, and Northwest Regional Transmission Organization (RTO West). The role of the International Standard Organization (ISO) was discussed, with reference to the Independent System Operator, Independent Market Operator, and Transmission and Market Planner. Redesign must involve all participants and include informed, phased in changes

Activities and influence of veterinary drug marketers on antimicrobial usage in livestock production in Oyo and Kaduna States, Nigeria

Directory of Open Access Journals (Sweden)

Olufemi Ernest Ojo

2017-09-01

Full Text Available Antimicrobial usage in animals contributes to the emergence of antimicrobial resistant bacterial strains. Investigations were carried out on how the characteristics, knowledge, attitude and practices of antimicrobial marketers influenced antimicrobials usage in animal production in Oyo and Kaduna States, Nigeria. Focus group discussions, in-depth interviews and structured questionnaires were used to gather information about the characteristics and activities of antimicrobial marketers. Overall, 70 (56.9 % of 123 marketers had post-secondary education while 76 (61.8 % were trained on the use of antimicrobials. Eighteen (14.6 % of the marketers were licensed veterinarians. Only 51 (41.5 % marketers displayed adequate knowledge about antimicrobials and antimicrobial usage. Sixty-seven (54.6 % marketers requested a prescription before selling antimicrobials while 113 (91.9 % marketer recommended antimicrobials for use in animals. Two-third of the marketers (66.7 % prescribed antimicrobials without physically examining sick animals but based their prescriptions on verbal reports of clinical signs by farmers and on their personal experience. Marketers with higher educational qualification displayed more adequate knowledge of antimicrobials and antimicrobial usage than those with basic education background only. More years of experience in antimicrobial marketing did not translate to better knowledge on antimicrobial usage. Only 45 (36.6 % respondents were aware of the existence of regulatory agencies monitoring the use of antimicrobials in animals. Farmers ignored the services of veterinarians in the diagnosis and control of animal diseases but resorted to drug marketers for help. Effective communication of existing legislations on antimicrobial usage, improved access to veterinary services and strict enforcement of regulatory policies are recommended for checking non-judicious use of antimicrobial agents in animal production. Sales of

Self-Regulatory Fatigue, Quality of Life, Health Behaviors, and Coping in Patients with Hematologic Malignancies

Science.gov (United States)

Ehlers, Shawna L.; Patten, Christi A.; Gastineau, Dennis A.

2015-01-01

Background Self-regulatory fatigue may play an important role in a complex medical illness. Purpose Examine associations between self-regulatory fatigue, quality of life, and health behaviors in patients pre- (N=213) and 1-year post-hematopoietic stem cell transplantation (HSCT; N=140). Associations between self-regulatory fatigue and coping strategies pre-HSCT were also examined. Method Pre- and 1-year post-HSCT data collection. Hierarchical linear regression modeling. Results Higher self-regulatory fatigue pre-HSCT associated with lower overall, physical, social, emotional, and functional quality of life pre- (p’sself-regulatory fatigue pre-HSCT relating to decreased quality of life and health behaviors, and predicting changes in these variables 1-year post-HSCT. PMID:24802991

The Chinese health care regulatory institutions in an era of transition.

Science.gov (United States)

Fang, Jing

2008-02-01

The purpose of this paper is to contribute to a better understanding of Chinese health care regulation in an era of transition. It describes the major health care regulatory institutions operating currently in China and analyzes the underlying factors. The paper argues that in the transition from a planned to a market economy, the Chinese government has been employing a hybrid approach where both old and new institutions have a role in the management of emerging markets, including the health care market. This approach is consistent with the incremental reform strategy adopted by the Party-state. Although a health care regulatory framework has gradually taken shape, the framework is incomplete, with a particular lack of emphasis on professional self-regulation. In addition, its effectiveness is limited despite the existence of many regulatory institutions. In poor rural areas, the effectiveness of the regulatory framework is further undermined or distorted by the extremely difficult financial position that local governments find themselves in. The interpretations of the principle of 'rule of law' by policy makers and officials at different levels and the widespread informal network of relations between known individuals (Guanxi) play an important role in the operation of the regulatory framework. The findings of this paper reveal the complex nature of regulating health care in transitional China.

ATMPs for Cancer Immunotherapy: A Regulatory Overview.

Science.gov (United States)

Galli, Maria Cristina

2016-01-01

This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

Use of risk information in regulatory reviews

International Nuclear Information System (INIS)

Sagar, B.; Benke, R.; Mohanty, S.

2004-01-01

The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

Liberalising the European natural gas market

International Nuclear Information System (INIS)

Mulder, M.

2002-01-01

Europe's natural gas market is changing radically. The several national markets dominated by monopolistic suppliers are integrating into one European market in which production and trade are subject to competition, while transport through the networks will be unbundled and placed under regulatory influence. What will be the consequences of these changes on natural gas prices, supply security and the environment?

A regulatory adjustment process for the determination of the optimal percentage requirement in an electricity market with Tradable Green Certificates

International Nuclear Information System (INIS)

Currier, Kevin M.

2013-01-01

A system of Tradable Green Certificates (TGCs) is a market-based subsidy scheme designed to promote electricity generation from renewable energy sources such as wind power. Under a TGC system, the principal policy instrument is the “percentage requirement,” which stipulates the percentage of total electricity production (“green” plus “black”) that must be obtained from renewable sources. In this paper, we propose a regulatory adjustment process that a regulator can employ to determine the socially optimal percentage requirement, explicitly accounting for environmental damages resulting from black electricity generation. - Highlights: • A Tradable Green Certificate (TGC) system promotes energy production from renewable sources. • We consider an electricity oligopoly operated under a TGC system. • Welfare analysis must account for damages from “black” electricity production. • We characterize the welfare maximizing (optimal) “percentage requirement.” • We present a regulatory adjustment process that computes the optimal percentage requirement iteratively

76 FR 74078 - Standard Mail Market Test

Science.gov (United States)

2011-11-30

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-3; Order No. 998] Standard Mail Market Test AGENCY... Service application for an exemption from the annual revenue limitation that applies to market tests of... limitation in any year during the test of an experimental market dominant product.\\1\\ Pursuant to 39 U.S.C...

E-laboratories : agent-based modeling of electricity markets

International Nuclear Information System (INIS)

North, M.; Conzelmann, G.; Koritarov, V.; Macal, C.; Thimmapuram, P.; Veselka, T.

2002-01-01

Electricity markets are complex adaptive systems that operate under a wide range of rules that span a variety of time scales. These rules are imposed both from above by society and below by physics. Many electricity markets are undergoing or are about to undergo a transition from centrally regulated systems to decentralized markets. Furthermore, several electricity markets have recently undergone this transition with extremely unsatisfactory results, most notably in California. These high stakes transitions require the introduction of largely untested regulatory structures. Suitable laboratories that can be used to test regulatory structures before they are applied to real systems are needed. Agent-based models can provide such electronic laboratories or ''e-laboratories.'' To better understand the requirements of an electricity market e-laboratory, a live electricity market simulation was created. This experience helped to shape the development of the Electricity Market Complex Adaptive Systems (EMCAS) model. To explore EMCAS' potential as an e-laboratory, several variations of the live simulation were created. These variations probed the possible effects of changing power plant outages and price setting rules on electricity market prices

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

Science.gov (United States)

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

Regulatory landscape for cell therapy--EU view.

Science.gov (United States)

McBlane, James W

2015-09-01

This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. For clinical trials, this can lead to different decisions in different countries for the same trial. A regulation is soon to come into force that will address this and introduce a more efficient clinical trial application process. However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators. Copyright © 2015.

Computer Security: posting and mis-posting

CERN Multimedia

Stefan Lueders, Computer Security Team

2015-01-01

This is what can happen at CERN if you don't lock your computer screen...   “Hi, I am looking for a partner either male or female to attend salsa lessons. I have a great body and enjoy rubbing it against other people on the dance floor. I would consider dinner after with the right person. If you think you can keep up with me and enjoy getting sweaty send me a reply. Stay sexy…” This is the original text of a recent posting on the CERN Market webpage. Some people might find this appealing, some people think this is funny. Personally, I couldn’t care less. But professionally, we had to follow up as this text can be perceived as inappropriate and, thus, in violation of the Terms of Usage of the CERN Market as well as the CERN Computing Rules and its annex on private usage of the CERN computing facilities. We remind you that the CERN Market is a public website that can be used by people within but also outside CERN. All posts are visible world...

78 FR 60358 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Science.gov (United States)

2013-10-01

... Schedule (``Fee Schedule'') to include an additional Market Maker monthly posting credit tier. The Exchange... Exchange proposes to amend the Fee Schedule to include an additional Market Maker monthly posting credit... currently offers two Market Maker monthly posting credit tiers applicable to posted electronic Market Maker...

Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

International Nuclear Information System (INIS)

Nichols, L.

2002-06-01

Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

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)

Flavored alcoholic beverages: an international marketing campaign that targets youth.

Science.gov (United States)

Mosher, James F; Johnsson, Diane

2005-09-01

Flavored alcoholic beverages (FABs) were first introduced into the alcohol market in the early I980s in the form of wine coolers. FABs are sweet, relatively low alcohol content beverages that are designed for "entry-level" drinkers. The alcohol industry has introduced new products and production methods to expand the category's popularity. Research suggests that they are popular with underage drinkers, particularly teenage girls, and that the industry uses marketing practices that appear to target youth. FABs are now marketed globally, and their production and marketing vary by country based on national regulatory restraints. In the United States, industry representations that the products are malt beverages for regulatory purposes appears to violate many state laws because the alcohol in the FABs is derived from distilled spirits. Recommendations for regulatory reform, including new legal definitions of FABs, increased taxes, and restrictions on availability, are applicable at both national and state levels.

77 FR 75198 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

Science.gov (United States)

2012-12-19

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0299] Standard Format and Content for Post-Shutdown... regulatory guide (DG), DG-1272, ``Standard Format and Content for Post-shutdown Decommissioning Activities... Content for Post-shutdown Decommissioning Activities Report,'' which was issued in July 2000. DG-1271...

Post-Purchase Evaluation in the Smartphone Market: An Investigation into Cognitive Dissonance among iPhone and Other Smartphone Brand Owners

OpenAIRE

Kraappa, Anna

2011-01-01

Purpose The main objective was to investigate whether iPhone owners experienced less cognitive post-purchase dissonance than other brand owners and was this due to the marketing communications efforts of Apple Inc., from hereon called Apple. Finally, the influence of Web 2.0 in the process of post-purchase evaluation was examined. Web 2.0 is a version of the Internet and it encourages towards user engagement on websites such as Facebook. Methodology A critical review of the litera...

Quick change: post-transcriptional regulation in Pseudomonas.

Science.gov (United States)

Grenga, Lucia; Little, Richard H; Malone, Jacob G

2017-08-01

Pseudomonas species have evolved dynamic and intricate regulatory networks to fine-tune gene expression, with complex regulation occurring at every stage in the processing of genetic information. This approach enables Pseudomonas to generate precise individual responses to the environment in order to improve their fitness and resource economy. The weak correlations we observe between RNA and protein abundance highlight the significant regulatory contribution of a series of intersecting post-transcriptional pathways, influencing mRNA stability, translational activity and ribosome function, to Pseudomonas environmental responses. This review examines our current understanding of three major post-transcriptional regulatory systems in Pseudomonas spp.; Gac/Rsm, Hfq and RimK, and presents an overview of new research frontiers, emerging genome-wide methodologies, and their potential for the study of global regulatory responses in Pseudomonas. © FEMS 2017.

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Government & Policy-Makers

Science.gov (United States)

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary brings together the relevant key findings for government and policy-makers from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and…

Danish and Chinese adolescents’ perceptions of healthy eating and attitudes toward regulatory measures

DEFF Research Database (Denmark)

Chan, Kara; Prendergast, Gerard; Grønhøj, Alice

2011-01-01

to be most effective in discouraging the consumption of soft drink. There were age, gender and market differences in attitudes toward selected regulatory measures that discourage the consumption of soft drinks. Research implications – Health educators and public health campaign designers should design health...... attempt to examine adolescents’ perception of healthy eating and attitudes toward food regulatory measures in more than one consumer market....

Market efficiency, competition, and communication in electric power markets. Experimental results

International Nuclear Information System (INIS)

Chapman, D.; Mount, T.D.; Vossler, C.A.; Barboni, V.; Thomas, R.J.; Zimmerman, R.D.

2004-01-01

Economic theory gives no clear indication of the minimum number of producers necessary for a market to define competitive price-quantity equilibria, which approximate price equal to marginal cost. Previous work and Federal Energy Regulatory Commission (FERC) guidelines generally suggest that 6-10 suppliers may be workably competitive. Our experiments with PowerWeb suggest that a higher number of suppliers may be necessary to approximate competitive market solutions, this in the absence of any communication among producers. As communications rules are altered to parallel differing types of antitrust enforcement, market results with 24 participants approach pure monopoly values

Mexico's Geothermal Market Assessment Report

Energy Technology Data Exchange (ETDEWEB)

Flores-Espino, Francisco [National Renewable Energy Lab. (NREL), Golden, CO (United States); Booth, Sarah [Booth Clean Energy LLC, Denver, CO (United States); Graves, Andrew [Dept. of Energy (DOE), Washington DC (United States)

2017-03-29

This report is intended to help U.S. companies in the geothermal sector understand potential business opportunities created by recent changes in the Mexican energy market and regulatory environment. can also provide a variety of technology products and services for export into the Mexican market. This report will help U.S. companies identify the many public and private sector stakeholders in the United States and Mexico, which can help U.S. companies navigate the new regulatory and permitting environment, build new partnerships, and identify vehicles for financial assistance and risk mitigation.

Telecommunications Reform in Nigeria: The Marketing Challenges ...

African Journals Online (AJOL)

Telecommunications Reform in Nigeria: The Marketing Challenges. ... Journal of Research in National Development ... This paper discusses the telecommunications reforms process, the role of the regulatory body (Nigeria Commission, the current state of the telecommunication sector and the marketing challenges in ...

Market and policy barriers to energy storage deployment :

Energy Technology Data Exchange (ETDEWEB)

Bhatnagar, Dhruv; Currier, Aileen B.; Hernandez, Jacquelynne; Ma, Ookie; Kirby, Brendan

2013-09-01

Electric energy storage technologies have recently been in the spotlight, discussed as essential grid assets that can provide services to increase the reliability and resiliency of the grid, including furthering the integration of variable renewable energy resources. Though they can provide numerous grid services, there are a number of factors that restrict their current deployment. The most significant barrier to deployment is high capital costs, though several recent deployments indicate that capital costs are decreasing and energy storage may be the preferred economic alternative in certain situations. However, a number of other market and regulatory barriers persist, limiting further deployment. These barriers can be categorized into regulatory barriers, market (economic) barriers, utility and developer business model barriers, crosscutting barriers and technology barriers. This report, through interviews with stakeholders and review of regulatory filings in four regions roughly representative of the United States, identifies the key barriers restricting further energy storage development in the country. The report also includes a discussion of possible solutions to address these barriers and a review of initiatives around the country at the federal, regional and state levels that are addressing some of these issues. Energy storage could have a key role to play in the future grid, but market and regulatory issues have to be addressed to allow storage resources open market access and compensation for the services they are capable of providing. Progress has been made in this effort, but much remains to be done and will require continued engagement from regulators, policy makers, market operators, utilities, developers and manufacturers.

Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

Science.gov (United States)

Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

2017-12-01

Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

77 FR 32159 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate...

Science.gov (United States)

2012-05-31

... the proposed rule change is available on the Exchange's Web site ( http://www.c2exchange.com/Legal... responsibilities. To more accurately reflect the current regulatory and compliance functions of the Regulatory... market and a national market system, and, in general, to protect investors and the public interest. The...

The PV market

International Nuclear Information System (INIS)

Hammond, B.

1992-01-01

This paper forecasts the photovoltaic (PV) market growth for the 1990s. Ten years of PV history are reviewed and used to establish market trends in terms of average selling price (ASP) and kilowatts shipped by market segment. The market is segmented into indoor consumer, stand-alone, and grid-connected applications. Indoor consumer presently represents a saturated market and is fairly predictable. The stand-alone market (i.e. not connected to the utility grid) is fairly stable and predictable. The utility PV market however is highly dependent on a number of market factors such as the cost of conventional energy the cost of PV systems utility acceptance of PV and regulatory controls. Government and institutional regulations, environmental issues, and OPEC and Middle East politics will have the greatest impact on the cost of conventional fuels. Private and federal investment in PV technology development could have a significant impact on the cost of PV systems. Forecasts are provided through the year 2000 for indoor consumer stand-alone and utility markets

Security of supply in the liberalized energy market

International Nuclear Information System (INIS)

Boffa, Federico

2007-01-01

The incentive schemes in the liberalized energy markets do not ensure short-term security of supply. The paper analyzes the regulatory measures suitable to tackle the issue, and evaluates their effects on market power [it

18 CFR 35.37 - Market power analysis required.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Market power analysis required. 35.37 Section 35.37 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Wholesale Sales of Electric Energy, Capacity and Ancillary Services at Market-Based Rates § 35.37 Market...

The post-transcriptional regulatory system CSR controls the balance of metabolic pools in upper glycolysis of Escherichia coli.

Science.gov (United States)

Morin, Manon; Ropers, Delphine; Letisse, Fabien; Laguerre, Sandrine; Portais, Jean-Charles; Cocaign-Bousquet, Muriel; Enjalbert, Brice

2016-05-01

Metabolic control in Escherichia coli is a complex process involving multilevel regulatory systems but the involvement of post-transcriptional regulation is uncertain. The post-transcriptional factor CsrA is stated as being the only regulator essential for the use of glycolytic substrates. A dozen enzymes in the central carbon metabolism (CCM) have been reported as potentially controlled by CsrA, but its impact on the CCM functioning has not been demonstrated. Here, a multiscale analysis was performed in a wild-type strain and its isogenic mutant attenuated for CsrA (including growth parameters, gene expression levels, metabolite pools, abundance of enzymes and fluxes). Data integration and regulation analysis showed a coordinated control of the expression of glycolytic enzymes. This also revealed the imbalance of metabolite pools in the csrA mutant upper glycolysis, before the phosphofructokinase PfkA step. This imbalance is associated with a glucose-phosphate stress. Restoring PfkA activity in the csrA mutant strain suppressed this stress and increased the mutant growth rate on glucose. Thus, the carbon storage regulator system is essential for the effective functioning of the upper glycolysis mainly through its control of PfkA. This work demonstrates the pivotal role of post-transcriptional regulation to shape the carbon metabolism. © 2016 John Wiley & Sons Ltd.

2015 Bioenergy Market Report

Energy Technology Data Exchange (ETDEWEB)

Warner, Ethan [National Renewable Energy Lab. (NREL), Golden, CO (United States); Moriarty, Kristi [National Renewable Energy Lab. (NREL), Golden, CO (United States); Lewis, John [National Renewable Energy Lab. (NREL), Golden, CO (United States); Milbrandt, Anelia [National Renewable Energy Lab. (NREL), Golden, CO (United States); Schwab, Amy [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2017-02-28

This report is an update to the 2013 report and provides a status of the markets and technology development involved in growing a domestic bioenergy economy as it existed at the end of 2015. It compiles and integrates information to provide a snapshot of the current state and historical trends influencing the development of bioenergy markets. This version features details on the two major bioenergy markets: biofuels and biopower and an overview of bioproducts that enable bioenergy production. The information is intended for policy-makers as well as technology developers and investors tracking bioenergy developments. It also highlights some of the key energy and regulatory drivers of bioenergy markets.

Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

Science.gov (United States)

Sakoulas, G

2009-12-01

The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

Application of Resource Portfolio Concept in Nuclear Regulatory Infrastructure Support

International Nuclear Information System (INIS)

Lee, Y. E.; Ha, J. T.; Chang, H. S.; Kam, S. C.; Ryu, Y. H.

2010-01-01

As the new entrants in the global nuclear construction market are increasing and the establishment of an effective and sustainable regulatory infrastructure becomes more important, they have requested international assistance from the international nuclear communities with mature nuclear regulatory programmes. It needs to optimize the use of limited resources from regulatory organization providing support to regulatory infrastructure of new comers. This paper suggests the resource portfolio concept like a GE/Mckinsey Matrix used in business management and tries to apply it to the current needs considered in the regulatory support program in Korea as the case study

Displacement in new economy labor markets: Post-displacement wage loss in high tech versus low tech cities.

Science.gov (United States)

Davis, Daniel J; Rubin, Beth A

2016-11-01

While scholars and politicians tout education as the salve to employment disruptions, we argue that the geography of the new economy, and the social closure mechanisms that geography creates, may be just as important as individuals' characteristics for predicting post-displacement wage loss (or gain). We use data from the 2012 Displaced Workers ement of the Current Population Survey and from the 2010 United States Census to test hypotheses linking local labor markets in different industrial contexts to post-displacement wage loss. Our results point to age as a closure mechanism, and to the partially protective effect of education in high-tech versus low-tech economic sectors. This study is the first to use national level data to examine how employment in high-tech cities influences post-displacement wages. These findings are relevant both for theorizing about the new economy and for public policy. Copyright © 2016 Elsevier Inc. All rights reserved.

Legal considerations for social media marketing by pharmaceutical industry.

Science.gov (United States)

Yang, Y Tony; Chen, Brian

2014-01-01

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

78 FR 56762 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and...

Science.gov (United States)

2013-09-13

... innovative pricing strategy. The Exchange notes that if the proposal results in a modest percentage increase... may apply to Market Makers including marketing fees, Options Regulatory Fees, market data, and...

Government intervention and market integration in Indonesian rice markets

OpenAIRE

Ismet, Mohammad; Barkley, Andrew P.; Llewelyn, Richard V.

1998-01-01

Long-run spatial price relationships in Indonesian rice markets and factors affecting the degree of market integration are evaluated using multivariate cointegration tests with weekly price data for the 1982-1993 period. The analysis includes evaluation of pre-self-sufficiency and post-self-sufficiency periods as well as for the entire period. The cointegration tests for entire Indonesian rice market, represented by the nine most relevant price series, indicate that relative to the pre-selfsu...

Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

Science.gov (United States)

Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

2011-12-01

The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

Science.gov (United States)

DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

2015-11-01

We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

76 FR 47630 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

Science.gov (United States)

2011-08-05

... data and other products available to persons that are not members of the self-regulatory organization... in self-regulatory organization governance was mandated by the Act, non-members should be given the... the evolution of self-regulatory organization governance and competitive market structure have...

A New Higher Education Marketing Mix: The 7Ps for MBA Marketing

Science.gov (United States)

Ivy, Jonathan

2008-01-01

Purpose: The purpose of this paper is to present a new marketing mix based on MBA students' attitudes and opinions towards the marketing initiatives of business schools in South Africa. The post-graduate business education market is, and increasingly, getting more aggressive in their efforts to attract students on to their flagship degree, the…

Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

International Nuclear Information System (INIS)

2003-01-01

The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database

The Ontario Energy Marketers Association

International Nuclear Information System (INIS)

Baker, W.F.C.

1998-01-01

An overview of the role of the Ontario Energy Marketers Association (OEMA) and its future orientation was presented. Participants in the OEMA include agents, brokers, marketers, local distribution companies, public interest representatives, associations and government representatives. The role of the OEMA is to encourage open competition for the benefit and protection of all energy consumer and market participants. As well, the OEMA serves as a forum for key industry stakeholders to resolve market issues outside the regulatory arena, set standards and codes of practice, establish customer education programs, and develop industry input into public policy making

77 FR 25770 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

Science.gov (United States)

2012-05-01

... settings via Regulatory Bulletin. The Mechanism protects Market Makers from the risk associated with an...-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending NYSE Amex Options Rule 928NY Specifying That the Potential Range for the Settings Applicable to the Market Maker Risk...

Air Markets Program Data (AMPD)

Data.gov (United States)

U.S. Environmental Protection Agency — The Air Markets Program Data tool allows users to search EPA data to answer scientific, general, policy, and regulatory questions about industry emissions. Air...

Twin-Peak Financial Regulatory Regime in China: A Desirability Analysis

DEFF Research Database (Denmark)

Hu, Chenchen

2015-01-01

In the past two decades, the Chinese financial markets have witnessed an unprecedented development and expansion, changing the landscape of the whole financial markets. But it has also drawn controversy with many scholars warning the negative consequences of the behemoth size and the increasing...... speed of the expansion of shadow banking activities. The banking activity expansion and the emergence of financial conglomerates have been challenging the effectiveness of the current institutional regulatory structure: the fragmented "One Bank and Three Commissions" system and the "Joint Meeting...... as a "deep context". By drawing on the Australia experience of the twin-peak reform and discussing the new ecology of the Chinese financial markets, the article attempts to answer the question of the desirability of a twin-peak regulatory regime in China....

A brighter future: sustainable markets for solar

International Nuclear Information System (INIS)

Luther, Joachim

1997-01-01

At the recent Solar World Congress of the International Solar Energy Society (ISES) in Taejon, Korea, delegates heard how continuing improvement of renewable energy technologies are combining with regulatory changes in energy markets to establish new opportunities for sustainable markets for solar and renewable energy. (author)

76 FR 25381 - Postal Service Market Test

Science.gov (United States)

2011-05-04

... POSTAL REGULATORY COMMISSION [Docket No. MT2009-4; Order No. 720] Postal Service Market Test... test, pending Commission action on anticipated request for permanent status. This document grants a one... temporarily extend its Collaborative Logistics market test under 39 U.S.C. 3641(d).\\1\\ The Commission...

Decision support methods for the detection of adverse events in post-marketing data.

Science.gov (United States)

Hauben, M; Bate, A

2009-04-01

Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

European Electricity Markets in Crisis: Diagnostic and Way Forward

International Nuclear Information System (INIS)

Roques, Fabien

2013-01-01

The European electricity industry is going through a profound crisis as several factors combine to create a challenging operating environment for thermal plants. The key issue is that the regulatory and market framework create a climate of deep policy and regulatory uncertainty which will hamper investments and will not deliver on the long term objectives of decarbonization and competitiveness of the European economy. This report analyses both the short and long term challenges for the European electricity markets, and highlights some directions for reform. The report has three main parts. The first part describes the current status quo and challenges associated with the long term decarbonization of the European economy: Section 1 sets the scene by describing the current challenges for the European electricity industry and the challenges associated with the long term decarbonization of the European economy; Section 2 quantifies the investment challenge for the electricity industry and shows how the current regulatory uncertainty undermines investments and will likely not deliver on the stated policy objectives; The second part of the report focusses on the 'extrinsic' issues which affect electricity markets: Section 3 reviews the wider context for electricity market liberalization, which calls for a rethink of the European energy policy framework, including the recent developments in global energy markets, as well as the impact of rising energy prices on economic competitiveness; Section 4 presents the distortive effects of support policies for low carbon technologies and the issues with the European carbon Trading Scheme; The third and last part of the report concentrates on the 'intrinsic issues' with electricity markets: Section 5 details the experience to date with European electricity markets liberalization, and highlights the achievements as well as the shortcomings of the liberalization and integration process; Section 6 dwells into the 'intrinsic issues

Market and Policy Barriers to Energy Storage Deployment

Energy Technology Data Exchange (ETDEWEB)

Bhatnagar, Dhruv [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Currier, Aileen [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Hernandez, Jacquelynne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ma, Ookie [Dept. of Energy (DOE), Washington DC (United States) Office of Energy Efficiency and Renewable Energy; Kirby, Brendan [Consultant

2013-09-01

Electric energy storage technologies can provide numerous grid services; there are a number of factors that restrict their current deployment. The most significant barrier to deployment is high capital costs, though several recent deployments indicate that capital costs are decreasing and energy storage may be the preferred economic alternative in certain situations. However, a number of other market and regulatory barriers persist, limiting further deployment. These barriers can be categorized into regulatory barriers, market (economic) barriers, utility and developer business model barriers, cross-cutting barriers and technology barriers.

A broadened causality in variance approach to assess the risk dynamics between crude oil prices and the Jordanian stock market

International Nuclear Information System (INIS)

Bouri, Elie

2015-01-01

Within the new developed causality-in-variance approach, this paper builds up a broad methodological framework to more accurately capture the risk spillover effects between global oil prices and Jordanian stock market returns during the period 1 March 2003–31 January 2014. The sample period is divided, on the basis of the 2008 financial crisis, into pre-crisis and post-crisis periods. Results for the pre-crisis period show a lack of risk spillovers between global oil and the Jordanian stock market. After the crisis, however, we find evidence for one-way risk spillover running from the oil market. These findings have implications for the design of appropriate asset allocation and regulatory policies to manage risk spillover effects. -- Highlights: •A broad methodological framework accurately seizes dynamic risk spillover between oil prices and Jordanian stock returns. •We find insignificant risk spillover until the start of the financial crisis. •Crude oil transmits its risk to the Jordanian stock market

A Marketing Perspective on Mergers and Acquisitions : How Marketing Integration Affects Postmerger Performance

OpenAIRE

Homburg, Christian; Bucerius, Matthias

2004-01-01

Previous research on mergers and acquisitions (M&A) has neglected marketing issues by and large. This paper examines the effects of post merger integration (PMI) in marketing (ex tent and speed of marketing integration) on M&A performance mediated by integration outcomes (magnitude of cost savings and market-related performance). Results from a survey of 232 horizontal mergers and acquisitions show that market-related performance after the merger or acquisition has a much stronger impac...

47 CFR 63.10 - Regulatory classification of U.S. international carriers.

Science.gov (United States)

2010-10-01

... demonstrates that the foreign affiliate lacks 50 percent market share in the international transport and the... 47 Telecommunication 3 2010-10-01 2010-10-01 false Regulatory classification of U.S. international... and Supplements § 63.10 Regulatory classification of U.S. international carriers. (a) Unless otherwise...

MARKETING CHARACTERISTICS OF INSURANCE MARKET IN UKRAINE

Directory of Open Access Journals (Sweden)

А. Sabirova

2014-03-01

Full Text Available The current state of the insurance market of Ukraine in the post-crisis period, by comparison with the pre-crisis was investigated in the paper. The insurance market in the pre-crisis period grew rapidly, but was unable to withstand the economic crisis and suffered a crushing blow. The economic crisis of 2008-2009 led to a decrease of the demand for financial services in general and insurance services in particular. The lack of development of the insurance market created high barriers for responding and adapting to changes that occurred during the crisis.

State regulatory issues in acid rain compliance

International Nuclear Information System (INIS)

Solomon, B.D.; Brick, S.

1992-01-01

This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

The Greek Electricity Market Reforms: Political and Regulatory Considerations

International Nuclear Information System (INIS)

Danias, Nikolaos; Kim Swales, John; McGregor, Peter

2013-01-01

The paper tracks the evolution of the Greek electricity market since the beginning of the liberalization process. Its progress is benchmarked against the criteria suggested by Littlechild (2006b). The Littlechild framework highlights key remaining deficiencies in the stances and policies adopted which need to be resolved in order for liberalization to proceed successfully. The focus is on the agendas of the Greek government, other domestic political forces and the European Union. A central requirement is the clear commitment to liberalization by the Greek government. In particular the government needs to give up political control over the previous vertically integrated, state-controlled electricity firm, Public Power Company (PPC), and allow more decision making powers and genuine independence to the market regulator. Liberalization is rendered more difficult by the present financial and economic crisis in Greece. - Highlights: • Greek electricity market liberalization is benchmarked against the Littlechild standard electricity market reform model. • Although the majority of the model requirements are met, liberalization in Greece is only partially successful. • Some elements of liberalization are qualitatively more significant than others. • More fundamental political economy issues need to be addressed in order for the liberalization to progress. • Financial crisis in Greece adds extra challenges

77 FR 61463 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2012-10-09

... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule...

77 FR 61449 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2012-10-09

..., regulatory and other risks of this business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

Science.gov (United States)

Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

2017-12-01

Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

International Nuclear Information System (INIS)

2003-01-01

The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database. refs., tabs., figs

Integrating gas and electric markets and regulation

International Nuclear Information System (INIS)

Whitmore, C.S.

1998-01-01

The issues determining what energy companies must do to compete in an increasingly competitive energy market and what regulators must do to ensure fairness in competition were discussed. The similarities of gas and electric markets, and the factors driving their integration were highlighted. The importance of communications and customer service in the energy market and the nature of market power in the gas and electric industries was described. Three reasons were given why gas/electric mergers will be beneficial: (1) operating efficiency, (2) applying gas experience to electric markets, and (3) opportunity to exercise market power. Potential regulatory problems were also reviewed

Visions of regulatory renewal

International Nuclear Information System (INIS)

Edgeworth, A.

1998-01-01

The economic contribution of the CEPA (Canadian Energy Pipeline Association) member companies to Canada's trade balance was discussed. CEPA member companies transport 95 per cent of the crude oil and natural gas produced in Canada to domestic and export markets. This represents a total of 5.6 Tcf of gas annually. Half of Canada's natural gas and oil production is exported to U.S. markets. All of these exports are transported by pipeline. CEPA member companies operate 90,000 km of pipeline from British Columbia to Quebec. Expansions are needed as a result of a significant increase in demand for natural gas and crude oil since 1990. Several issues exist for regulatory renewal. They include the need to create a level playing field, the overseeing of tolls and contract renewal terms, changing risk/reward trade-offs, the right to confidentiality of information and price discovery mechanism. The drivers for regulatory reform at Westcoast Energy are the need for pricing flexibility, customers desire for toll certainty, decontracting and opposition to rolled-in expansions for gathering and processing. An overview of Westcoast Energy's negotiated toll settlement, its implications, and the components of Westcoast Energy's 'light handed regulation' (LHR) was presented

Innovations in Post-Marketing Safety Research

NARCIS (Netherlands)

Stefánsdóttir, G.

2012-01-01

Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

Science.gov (United States)

Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

2017-05-22

Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

Regulatory policy and structural change in the natural gas industry: A transaction cost perspective

International Nuclear Information System (INIS)

Sauer, D.G.

1991-01-01

The Federal Energy Regulatory Commission has recently promoted policy initiatives designed to substitute market responsive industry practices for the micro-management regulatory practices previously employed. These new policies are expected to generate a flexible gas pricing policy that more accurately reflects market supply and demand conditions. Historically, much of the regulation of this industry was enacted to ensure that pipeline companies would be able to recover the very large up-front investments in immobile equipment that characterize the production, transportation, storage, and distribution of natural gas. The institutional detail available from historical accounts of the development of the industry are used to describe structural change over time. Regulatory policy, the level of asset specificity, and the extent of secondary environmental uncertainty are all shown to exert significant effects on the level of integration into production, storage and marketing

Regulatory review of safety cases and safety assessments for near surface

International Nuclear Information System (INIS)

Nys, V.

2003-01-01

The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

Are households better off in liberalized electricity markets

DEFF Research Database (Denmark)

Olsen, Ole Jess; Johnsen, Tor Arnt; Pakkanen, Merja

wholesale market. Norway was first (1991), then came Finland and Sweden (1996) and Denmark was last (2000). Together with the UK the Nordic countries are now considered the avantgarde with respect to implementation of the European electricity market directives. The purpose of liberalization is to increase...... utilities mostly acted under very little surveillance and the authorities only intervened in specific cases of abuse. The separation of operational and regulatory functions was far from clear-cut - state and municipal agencies often had both functions. Today much more detailed principles of regulations...... administrated by independent regulatory agencies have been developed. The purpose of this paper is to analyze the situation for Nordic household consumers after liberalization of the electricity supply industry. A number of new regulatory principles have been introduced and some of them with particular regard...

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Tertiary Education Providers & School Educators

Science.gov (United States)

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary brings together the relevant key findings for tertiary education providers and school educators from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between…

Progress on mobility and instability of research personnel in Japan: scientometrics on a job-posting database for monitoring the academic job market

Energy Technology Data Exchange (ETDEWEB)

Kawashima, H.; Yamashita, Y.

2016-07-01

This study has two purposes. The first purpose is to extract statistics from a database of jobposting cards, previously little-used as a data source, to assess the academic job market. The second purpose is to connect statistics on the academic job market with monitoring of indicators of policy progress related to the mobility and instability of research personnel. The data source used in this study is a job-posting database named JREC-IN Portal, which is the de facto standard for academic job seeking in Japan. The present results show a growing proportion of fixed-term researchers in the Japanese academic job market and that job information is increasingly diverse. (Author)

76 FR 19355 - Notice of Staff Attendance at Southwest Power Pool Markets Operations Policy Committee Meeting

Science.gov (United States)

2011-04-07

...) Markets Operations Policy Committee (MOPC), as noted below. Their attendance is part of the Commission's... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at Southwest Power Pool Markets Operations Policy Committee Meeting The Federal Energy Regulatory Commission hereby...

77 FR 33788 - Proposed Post Office Structure Plan

Science.gov (United States)

2012-06-07

... Plan AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service request for an advisory opinion regarding its Post Office Structure Plan... Commission for an advisory opinion under 39 U.S.C. 3661 regarding its Post Office Structure Plan (POStPlan...

Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

Science.gov (United States)

Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

2017-09-12

A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

China to Step up Supervision of Futures Market

Institute of Scientific and Technical Information of China (English)

无

2010-01-01

China will intensify its supervision and regulation of the futures market,and severely crack down on insider trading and market manipulation,according to the country’ssecurities regulator. Jiang Yang,Assistant to Chairman of the China Securities Regulatory Commission(CSRC),said Friday at the sixth International

75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Science.gov (United States)

2010-05-13

... regulatory issues and their potential impact on investors and the securities markets. The Committee will lend... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Securities and...

Regulatory T Cells in Post-stroke Immune Homeostasis.

Science.gov (United States)

Liesz, Arthur; Kleinschnitz, Christoph

2016-08-01

The secondary neuroinflammatory response has come into focus of experimental stroke research. Immunological mechanisms after acute stroke are being investigated in the hope to identify novel and druggable pathways that contribute to secondary infarct growth after stroke. Among a variety of neuroimmunological events after acute brain ischemia, including microglial activation, brain leukocyte invasion, and secretion of pro-inflammatory factors, lymphocytes have been identified as the key leukocyte subpopulation driving the neuroinflammatory response and contributing to stroke outcome. Several studies have shown that pro-inflammatory lymphocyte subpopulations worsen stroke outcome and that inhibiting their invasion to the injured brain is neuroprotective. In contrast to the effector functions of pro-inflammatory lymphocytes, regulatory T cells (Treg) are critically involved in maintaining immune homeostasis and have been characterized as disease-limiting protective cells in several inflammatory conditions, particularly in primary inflammatory diseases of the central nervous system (CNS). However, due to the complex function of regulatory cells in immune homeostasis and disease, divergent findings have been described for the role of Treg in stroke models. Emerging evidence suggests that this discrepancy arises from potentially differing functions of Treg depending on the predominant site of action within the neurovascular unit and the surrounding inflammatory milieu. This article will provide a comprehensive review of current findings on Treg in brain ischemia models and discuss potential reasons for the observed discrepancies.

Regulatory Issues Surrounding Merchant Interconnection

International Nuclear Information System (INIS)

Kuijlaars, Kees-Jan; Zwart, Gijsbert

2003-11-01

We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections

Regulatory Issues Surrounding Merchant Interconnection

Energy Technology Data Exchange (ETDEWEB)

Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

2003-11-01

We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

77 FR 68185 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

Science.gov (United States)

2012-11-15

... importance and expense of the Exchange's regulatory efforts and competitive pricing pressures and to ensure... Exchange participates in a highly competitive market in which regulatory costs are continually increasing...

Market power monitoring and mitigation in the US wholesale power markets

Energy Technology Data Exchange (ETDEWEB)

Helman, Udi [Federal Energy Regulatory Commission, 888 First Street, N.E., Washington, DC 20426 (United States)

2006-05-15

Under current statutory requirements, the Federal Energy Regulatory Commission (FERC) must ensure that prices in US wholesale power markets are 'just and reasonable'. This has been interpreted by the agency and the courts as requiring the monitoring and mitigation of undue market power. This paper focuses on generation market power. Prior to electricity sector restructuring, wholesale bilateral power trading took place among vertically integrated monopoly utilities trading at the margin or between small independent producers and the utilities. Under those conditions, the authorization of trading at market prices, called 'market-based rates', required only that the generation supplier pass a simple market share screen for market power. As restructuring unfolded, and market conditions changed, there has been a steady evolution in FERC's market power mitigation rules, encompassing (a) changes in the market power assessment required for granting market-based rates and related methods for merger approval, and (b) development and refinement of new techniques for screening and mitigating offers into the organized day-ahead and real-time markets operated by Independent System Operators (ISOs) and Regional Transmission Organizations (RTOs). This paper reviews these changes to date, as FERC continues to clarify its approved rules and procedures. It also examines recent methods for quantitative market power analysis that could augment current procedures or supplant them, as found appropriate. (author)

Regulatory Capital: Why Is It Different?

NARCIS (Netherlands)

Schoenmaker, D.

2015-01-01

The global financial crisis has highlighted that deviations between the accounting and regulatory concepts of equity capital have gone too far. Accounting standards have been going too far in the application of fair value accounting. If there are no markets during times of crises, it does not make

Regulatory governance of telecommunications liberalisation in Taiwan

International Nuclear Information System (INIS)

Cheng, Kuo-Tai; Hebenton, Bill

2008-01-01

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Regulatory governance of telecommunications liberalisation in Taiwan

Energy Technology Data Exchange (ETDEWEB)

Cheng, Kuo-Tai [Department of Regional Studies in Humanity and Social Sciences, National Hsin-Chu University of Education, No. 521 Nan-Da Road, Hsin-Chu 300 (China); Hebenton, Bill [School of Law, University of Manchester, M13 9PP (United Kingdom)

2008-12-15

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Navigating the global carbon market

International Nuclear Information System (INIS)

Schneider, Malte; Hendrichs, Holger; Hoffmann, Volker H.

2010-01-01

From a slow start, the clean development mechanism (CDM) market has recently experienced enormous growth. However, the CDM market has been increasingly criticised, resulting in a lively debate about how to reform, complement, or replace it. In order to increase transparency and assist policy-makers in better understanding the current market, we depart from the traditional project-level perspective on CDM and analyse commercial activities by utilising data from UNEP Risoe's CDM Bazaar. To this end, we first establish a seven-step value chain by conducting a factor analysis on the commercial activities indicated in the Bazaar and, second, identify nine prevalent business models with a cluster analysis of all 495 participating organisations. Based on these analyses, we discuss potential impacts on the value chain of different policy scenarios that rely on carbon credits as incentive. We find that the importance of specific regulatory CDM know-how and general business activities such as finance varies strongly with the different policy scenarios. Our analysis serves to sensitise policy-makers and business about implications of different regulatory designs.

Contemporary Welfare Regimes in Baltic States: Adapting Post-Communist Conditions to Post-Modern Challenges

Directory of Open Access Journals (Sweden)

Anu Toots

2010-11-01

Full Text Available This article revises the conventional approach to welfare state development in the post-communist world, according to which the main challenge for the Eastern European states is to catch up with Western European welfare regimes. The article argues that adjustment to the new social risks and volatile markets is more important today than the catching-up scenario. Based on social and labour market statistics for Estonia, Latvia and Lithuania, the article analyses how the Baltic States are coping with this adjustment challenge. Adaptation to the post-modern conditions can be regarded as successful if the stability of welfare spending is accompanied by the expanding and flexible employment and by the stable or decreasing level of poverty. The findings suggest that the opportunities to increase the flexibility and equality of the labour market provided by the breakdown of the communist regime were not used. Instead, the Baltic welfare states continue to focus on protecting against the old social risks by combining neoliberal and post-communist principles. Poor performance in meeting new social risks poses a greater challenge for the post-communist welfare states than their lag in terms of gross welfare expenditure.

Bubbles, Post-Crash Dynamics, and the Housing Market

OpenAIRE

Crocker H. Liu; Adam Nowak; Stuart Rosenthal

2014-01-01

This paper documents and explains previously unrecognized post-crash dynamics following the collapse of a housing bubble. A simple model predicts that speculative developers ensure stable pre-crash relative prices between small and large homes while their post-crash exit allows small-home relative values to fall. Evidence from Phoenix supports the model. Although home prices doubled 2004-2006, relative prices of small-to-large homes remained nearly constant but then plummeted post-crash. As s...

Market surveillance in Ontario

International Nuclear Information System (INIS)

Chandler, H.

2002-01-01

On May 1, 2002 both wholesale and retail electricity markets in Ontario were opened to competition. Wholesale electricity market sales of 150 TWh were valued at over $11 billion with 27,500 MW in service installed capacity and 4,000 to 6,000 MW import/export capability with strong interconnections to the Quebec, the Midwest and the Northeast. The key players in Ontario's electricity market are the Ontario Energy Board (OEB), the Independent Electricity Market Operator (IMO), Ontario Power Generation, and Hydro One. The OEB regulatory framework includes licensing and front line, daily monitoring of whole sale market. Serious capacity problems in Ontario have manifested themselves in tight supply and demand situations and highly volatile prices. The paper included graphs of available reserves for 1996 to 2002, HOEP trends and frequency, HOEP comparison, and a sensitivity to demand forecast. 1 tab., 6 figs

Effect of business regulation on investment in emerging market economies

Directory of Open Access Journals (Sweden)

Birungi Korutaro

2013-01-01

Full Text Available This paper provides an empirical analysis of the business regulatory factors that influence investment in a selection of 29 emerging market economies. Both theoretical and empirical literature on the effect of the regulatory environment on investment is reviewed. A panel data analysis over the period 2003–2007 reveals that investment is influenced by secure property rights and the degree of business entry regulation. The results carry important policy implications for improving the investment climate of emerging market economies.

Energy-only and capacity markets and the economics of the power sector in a simulation of the Northwest European power market

International Nuclear Information System (INIS)

Hers, Sebastiaan; Redl, Christian; Wijk, Pieter van der; Slot, Thijs

2013-01-01

Rising concern with regard to generation adequacy and the ability of energy-only electricity markets to deliver required investments induced debates, regulatory interventions, and consideration of new market mechanisms in several EU member states. Results based on model simulations concerning guaranteed supply safety are presented. (orig.)

Energy-only and capacity markets and the economics of the power sector in a simulation of the Northwest European power market

Energy Technology Data Exchange (ETDEWEB)

Hers, Sebastiaan; Redl, Christian; Wijk, Pieter van der; Slot, Thijs [DNV KEMA Energy and Sustainability, Arnhem (Netherlands)

2013-11-01

Rising concern with regard to generation adequacy and the ability of energy-only electricity markets to deliver required investments induced debates, regulatory interventions, and consideration of new market mechanisms in several EU member states. Results based on model simulations concerning guaranteed supply safety are presented. (orig.)

Changing patterns of competition in European gas markets

International Nuclear Information System (INIS)

Heren, P.

1996-01-01

Despite a period of statism in the European natural gas market, the author argues that economic, political and regulatory pressures are approaching which will force dramatic change in the market, and identifies factors relating to pipeline capacity, competition, prices and market changes and fuel use which will drive the changes. A historical perspective is used as a framework to explain the inevitability of these changes. (UK)

Structure, control and regulation of the formal market for medicinal plants' products in Nigeria.

Science.gov (United States)

Oguntade, Adegboyega E; Oluwalana, Isaac B

2011-01-01

There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

Methodology for the identification, evaluation and prioritization of market handicaps which prevent the implementation of Demand Response: Application to European electricity markets

International Nuclear Information System (INIS)

Alcázar-Ortega, Manuel; Calpe, Carmen; Theisen, Thomas; Carbonell-Carretero, José Francisco

2015-01-01

This paper presents a methodology for the identification, analysis and comparative assessment of the handicaps which nowadays prevent the higher implementation of Demand Response (DR) in the electricity market. Its application provides a hierarchical organization of handicaps from the most critical to the less critical and then, from the easiest to the most difficult to overcome. This makes possible to determine which barriers would be a priority, which may indicate the direction of regulatory changes to properly address these handicaps and so, stimulating a higher participation of the demand side in electricity markets. After applying the methodology to three European countries, 34 handicaps have been identified, analyzing which of these handicaps affect such stakeholders as grid operators, retailers and customers and how these stakeholders are affected. For each handicap, the criticality and difficulty to overcome the different handicaps have been studied, based on detailed information coming from personal interviews to experts representing the different stakeholders in the electricity trading chain. Regulatory barriers have been identified as the most critical and difficult to overcome. Together with regulatory changes, the promotion of aggregators and the training of customers on DR applications are some of the most significant initiatives. - Highlights: • Market handicaps prevent the application of Demand Response in electricity markets. • A methodology to identify and organize such market handicaps has been developed. • The evaluation and quantification of criticality and difficulty to overcome is done. • A hierarchical list prioritizing handicaps to be addressed is obtained. • Market handicaps of three European countries were evaluated through this methodology.

Can preapproval jump-start the allowance market

Energy Technology Data Exchange (ETDEWEB)

Dudek, D.J.; Goffman, J.

1992-06-01

With compliance deadlines approaching in three years, utility, environmental and financial planners and their regulators are in the process of grappling with the requirements imposed, and opportunities created, by the acid rain program established under Title 4 of the Clean Air Act amendments of 1990. The novel element of the program - emissions or allowance trading through a nationwide allowance market - presents great challenges for utilities and their regulators. Perhaps the foremost challenge is establishing the allowance market. If state utility commissions subject utilities' compliance strategies to traditional after-the-fact prudence reviews, as tradition would impel them to do, the attendant regulatory risks are likely to push utilities toward more conservative compliance schemes that underuse allowance trading (as the exchange at the head of this article demonstrates). If that happens, the market will fail to develop, and its full potential for environmental benefit at least cost will go unrealized. This, in turn, is likely to strengthen the case for non-market regulatory mechanisms - a vicious circle. In this paper, the authors suggest a way out of this.

Can preapproval jump-start the allowance market?

International Nuclear Information System (INIS)

Dudek, D.J.; Goffman, J.

1992-01-01

With compliance deadlines approaching in three years, utility, environmental and financial planners and their regulators are in the process of grappling with the requirements imposed, and opportunities created, by the acid rain program established under Title 4 of the Clean Air Act amendments of 1990. The novel element of the program - emissions or allowance trading through a nationwide allowance market - presents great challenges for utilities and their regulators. Perhaps the foremost challenge is establishing the allowance market. If state utility commissions subject utilities' compliance strategies to traditional after-the-fact prudence reviews, as tradition would impel them to do, the attendant regulatory risks are likely to push utilities toward more conservative compliance schemes that underuse allowance trading (as the exchange at the head of this article demonstrates). If that happens, the market will fail to develop, and its full potential for environmental benefit at least cost will go unrealized. This, in turn, is likely to strengthen the case for non-market regulatory mechanisms - a vicious circle. In this paper, the authors suggest a way out of this

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.

What is the optimum social marketing mix to market energy conservation behaviour: an empirical study.

Science.gov (United States)

Sheau-Ting, Low; Mohammed, Abdul Hakim; Weng-Wai, Choong

2013-12-15

This study attempts to identify the optimum social marketing mix for marketing energy conservation behaviour to students in Malaysian universities. A total of 2000 students from 5 major Malaysian universities were invited to provide their preferred social marketing mix. A choice-based conjoint analysis identified a mix of five social marketing attributes to promote energy conservation behaviour; the mix is comprised of the attributes of Product, Price, Place, Promotion, and Post-purchase Maintenance. Each attribute of the mix is associated with a list of strategies. The Product and Post-purchase Maintenance attributes were identified by students as the highest priority attributes in the social marketing mix for energy conservation behaviour marketing, with shares of 27.12% and 27.02%, respectively. The least preferred attribute in the mix is Promotion, with a share of 11.59%. This study proposes an optimal social marketing mix to university management when making decisions about marketing energy conservation behaviour to students, who are the primary energy consumers in the campus. Additionally, this study will assist university management to efficiently allocate scarce resources in fulfilling its social responsibility and to overcome marketing shortcomings by selecting the right marketing mix. Copyright © 2013 Elsevier Ltd. All rights reserved.

Are All Marketers Liars ?

OpenAIRE

Sunanto, Sandra

2006-01-01

Today, consumers demand higher levels of quality, reliability, and durability of product A marketer must understand consumer's expectations and try to satisfy those and retain the consumer's loyalty.The shift from golden age of marketing to post age creates new challenge for marketer because consumers do not trust television commercials anymore. In this age consumers love being told a storyTo tell a story marketer must understand what is a great story. A great story must true, authentic, trus...

76 FR 76712 - Notice of Staff Attendance at Southwest Power Pool Markets and Operations Policy Committee Meeting

Science.gov (United States)

2011-12-08

.... Markets and Operations Policy Committee. Their attendance is part of the Commission's ongoing outreach... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at Southwest Power Pool Markets and Operations Policy Committee Meeting The Federal Energy Regulatory Commission...

Regulatory and institutional challenges of corporate governance in ...

African Journals Online (AJOL)

Regulatory and institutional challenges of corporate governance in post banking consolidation Nigeria. ... PROMOTING ACCESS TO AFRICAN RESEARCH ... From a banking industry perspective, good corporate governance demands

The perspectives of the French biogas market

International Nuclear Information System (INIS)

2012-05-01

After having outlined that France is the fourth European producer of biogas, that regulatory evolutions have been adopted in 2012 to support the market, and that operators are trying to take place on this market, this document proposes the table of content of a market study which addresses the following topics: definition, resources and valorisation modes, legal framework and support measures taken by public authorities, investments, costs and profitability of a biogas project, current status of production and valorisation of biogas in France and market perspectives, presentation of main actors and of their development strategies

Spanish generation market: structure, design and results

International Nuclear Information System (INIS)

Agosti, L.; Padilla, A. J.; Requejo, A.

2007-01-01

This paper provides an overview of the structure, design and outcome of the Spanish generation market from 1998, when the market was liberalised, to date. More precisely, this paper reviews the history of the liberalisation process; describes the structure of the generation market and its evolution over time; analyses the existence of market power; and evaluates the outcome of the liberalisation process from the viewpoint of its impact on al locative efficiency, productive efficiency and dynamic efficiency. The paper concludes with a brief summary of recent regulatory reforms. (Author)

What do implementers need in terms of regulatory safety criteria for the post-closure phase?

International Nuclear Information System (INIS)

Cahen, B.

2010-01-01

Bruno Cahen, Director Safety Division (ANDRA) presented the point of view of the NEA Integration Group for the Safety Case (IGSC) on 'What do implementers need in terms of regulatory safety criteria for the post-closure phase?' B. Cahen acknowledged that the national experience in siting and developing conceptual designs of geological disposal is growing rapidly. It implies increasing opportunities for interactions between implementers and regulators. There has been large development of international guidance in the recent years. Many regulators have already developed a regulatory framework. The implementers need practical, transparent and deliverable regulations. These regulations should draw on experiences gained from development of geological disposal projects. The IGSC has identified five key questions that the RF may focus on: 1. Over what time frame are the waste deemed to present a hazard? 2. Over what time frames are regulatory criteria applied and do they change over time? 3. Over what time frame(s) are safety assessments required to be conducted? 4. How do implementers have to address uncertainties in the long time frames? 5. What happens after cut-offs: are additional analyses needed? What types of arguments are to be used? Stable, understandable and practical criteria mean, namely, that they need to be developed on a strong scientific and societal basis, that there is consistency of safety options and requirements for different types of waste, that, in the longer time frames, the emphasis is given to robust systems, passive safety and multiple safety functions and that the criteria should fit the various phases of the project (siting, designing, operating, closure and post-closure). Experience feedback from safety cases shows that safety priorities depend very much on time frames. The derived safety criteria for the individual components should lead to measurable, verifiable specifications. The assessment of geological repository post-closure safety

Deferred Tax Assests and Bank Regulatory Capital

NARCIS (Netherlands)

Gallemore, J.

2012-01-01

Abstract: In this study, I examine three issues: (1) whether the probability of bank failure is increasing in the proportion of regulatory capital composed of deferred tax assets (DTA), (2) whether market participants incorporate the increased failure risk associated with the DTA component of

Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

Science.gov (United States)

2011-01-01

Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA) and abscisic acid (ABA) are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up-regulated by both GA and seed

Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

Directory of Open Access Journals (Sweden)

Lin Li

2011-06-01

Full Text Available Abstract Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA and abscisic acid (ABA are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up

Muddling up the Market: New Exempt- Market Regulations may do more Harm than Good to the Integrity of Markets

Directory of Open Access Journals (Sweden)

Jack M. Mintz

2014-11-01

Full Text Available From private debt and equity markets to crowd funding, exempt markets have been used to raise more money for Canadian enterprises in recent years than all public offerings put together. Vastly more: Between 2010 and 2012, exempt-market offerings raised four times as much capital as the initial and secondary public offerings during the same period. The precise reasons behind the immense popularity of exempt markets can only be guessed at; it may well be due to the desire, by both issuers and by investors, to avoid the regulatory costs associated with raising capital in public markets. We are left to speculate, however, because the Canadian exempt market remains relatively unstudied, despite its enormous role in funding capital investments in Canada. The lack of information about exempt markets, however, is not stopping provincial regulators in Canada’s largest markets from charging ahead with new proposals for rules that would govern exempt markets. Unfortunately, with so little information available about these markets, whatever the aim of the reforms in pursuing the goals of effective market regulation, they may end up being more harmful than helpful. Ontario is proposing to broaden the category of investors eligible to participate in these markets under a new exemption. But the category will remain stricter than in many other markets and Ontario proposes to also put very low limits on how much each investor is allowed to put at risk. Quebec, Alberta and Saskatchewan are also proposing the same $30,000 limit for any given 12-month period. And Ontario will prohibit the sale of exemptmarket securities by agents that are related to, or affiliated with, the registrant, even if measures are employed that have previously been accepted in managing and mitigating conflicts of interest. This will have a direct and damaging impact on exempt-market dealers, who are only allowed to sell exempt-market securities. All of these proposals are intended to

Federal Trade Commission Semiannual Regulatory Agenda