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Pharmaceutical Sector (pharmaceutical + sector)
Selected AbstractsCredible Commitment in Non-Independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and FoodstuffsEUROPEAN LAW JOURNAL, Issue 5 2004Sebastian Krapohl Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products. [source] Review: Microscale methods for high-throughput chromatography development in the pharmaceutical industryJOURNAL OF CHEMICAL TECHNOLOGY & BIOTECHNOLOGY, Issue 7 2009Sunil Chhatre Abstract Demands within the pharmaceutical sector to cut costs and improve process efficiencies have grown considerably in recent years. Major challenges exist for companies trying to establish financially viable and robust manufacturing processes for increasingly complex therapeutics. These issues have driven the investigation of miniaturised process-design techniques by which to identify suitable operating conditions using small volumes of feed material typical of that available in the early stages of bioprocess development. Such techniques are especially valuable for the optimisation of chromatographic separations, which often represent a significant percentage of manufacturing costs and hence for which there is a pressing need to determine the best operating policies. Several methods employing microlitre volumes of sample and resin have been explored recently, which are aimed at the high-throughput and cost-effective exploration of the design space for chromatographic separations. This methodology paper reviews these microscale approaches and describes how they work, gives examples of their application, discusses their advantages and disadvantages and provides a comparative assessment of the different methods, along with a summary of the challenges that remain to be overcome in relation to these techniques. Copyright © 2009 Society of Chemical Industry [source] Professional development of statisticians in the pharmaceutical sector: evolution over the past decade and into the futurePHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 3 2008Trevor Lewis CStat Abstract The adoption of The International Conference on Harmonization Tripartite Guideline: Statistical Principles for Clinical Trials (ICH-E9) has provided a foundation for the application of statistical principles in clinical research and raised awareness of the value of a statistical contribution to the wider pharmaceutical R&D process. In addition, over the past decade globalization of the pharmaceutical R&D process and the measures taken to address reduced productivity and spiralling costs have impacted on the roles and career opportunities for statisticians working in the pharmaceutical sector. This has enhanced the need for continuing professional development to equip statisticians with the skills to fully contribute to creating innovative solutions. In the future, key areas of focus are the establishment of professional standards for statistical work and increasing the collaboration between statisticians working in industry, regulatory agencies and academia. In addition, the diversity of roles and potential career paths for statisticians embarking on a career in the pharmaceutical sector emphasizes the importance of mentoring and coaching. For the more experienced statisticians, there are unprecedented opportunities to lead and innovate. Copyright © 2008 John Wiley & Sons, Ltd. [source] An aviation perspective of safety in the pharmaceutical sector,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2008Tor Krokstad No abstract is available for this article. [source] Management tools for the evaluation of compliance and costs in the production of chemical,pharmaceutical companiesQUALITY ASSURANCE JOURNAL, Issue 3 2005Franziska Rank Abstract Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical,pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical,pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright © 2005 John Wiley & Sons, Ltd. [source] Patents and Pharmaceutical R&D: Consolidating Private,Public Partnership Approach to Global Public Health CrisesTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 4 2010Chidi Oguamanam Intellectual property (IP) is a reward and incentive market-driven mechanism for fostering innovation and creativity. The underlying, but disputed, assumption to this logic is that without IP, the wheel of innovation and inventiveness may grind to a halt or spin at a lower and unhelpful pace. This conventional justification of IP enjoys, perhaps, greater empirical credibility with the patent regime than with other regimes. Despite the inconclusive role of patents as a stimulant for research and development (R&D), special exception is given to patent's positive impact on innovation and inventiveness in the pharmaceutical sector. This article focuses on that sector and links the palpable disconnect between the current pharmaceutical R&D agenda and global public health crises, especially access to drugs for needy populations, to a flaw in the reward and incentive theory of the patent system. It proposes a creative access model to the benefits of pharmaceutical research by pointing in the direction of a global treaty to empower and institutionalize private,public partnerships in health care provisions. Such a regime would restore balance in the global IP system that presently undermines the public-regarding considerations in IP jurisprudence. [source] Effect of the TRIPS-Mandated Intellectual Property Rights on Foreign Direct Investment in Developing Countries: A Case Study of the Indian Pharmaceutical IndustryTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 5-6 2008Rajnish Kumar Rai The Agreement on Trade-Related Aspects of Intellectual Property Rights is the most important as well as the most controversial instrument to date concerning intellectual property protection. What is not clear is the impact it will have on developing countries and whether it will actually meet its objective in the ", promotion of technological innovation and to the transfer and dissemination of technology ,". The proponents of a strong patent regime vehemently argue that strengthening patent protection will lead to greater technology transfer in developing countries, and consequently inflow of foreign direct investment (FDI) as it is the most important channel for technology transfer. This article takes the Indian pharmaceutical industry as an example to examine the above assertion, and argues that simply enhancing patent protection may not necessarily result in a corresponding increase in FDI in the Indian pharmaceutical sector. It shows that in addition to strong patent protection, there are equally or even more important factors that have a bearing on the inflow of FDI. [source] TRIPS-Plus Implications for Access to Medicines in Developing Countries: Lessons from Jordan,United States Free Trade AgreementTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 6 2007Hamed El-Said Since the establishment of the World Trade Organization (WTO) in 1995 and implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as a result, the United States (US) sought to impose still higher levels of intellectual property rights on developing countries, a phenomenon that is commonly known today as TRIPS-Plus. The Jordan,US FTA, signed in 2001, contains several TRIPS-Plus rules that restrict the poor's access to medicines, and is today touted by US officials and the US Trade Representative (USTR) as a success, and providing a wide range of benefits. These benefits not only include a higher growth rate, but also more specific benefits to the pharmaceutical sector in particular, such as an improved ability to develop generic medicine and engage in new innovative research, as well as increasing the presence of and collaboration with multinational drug makers. This article analyzes in detail the TRIPS-Plus provisions of the Jordan,US FTA. It challenges the claims that the FTA brings general and specific benefits to developing countries, and provides fresh evidence which strongly suggests that benefits from the Jordan,US FTA have been largely exaggerated while the costs underestimated. [source] The Political Economy of AIDS Treatment: Intellectual Property and the Transformation of Generic SupplyINTERNATIONAL STUDIES QUARTERLY, Issue 3 2007Kenneth C. Shadlen This article examines the relationship between intellectual property (IP) and public health, with a focus on the extension of AIDS treatment in the developing world. While most of the literature on IP and health examines the conditions affecting poor countries' capacities to acquire essential medicines, I show the distinct,and more complicated,political economy of production and supply. IP regulations alter the structure of generic pharmaceutical sectors in the countries capable of supplying essential medicines, and changes in market structure affect actors' economic and political interests and capacities. These new constellations of interests and capacities have profound implications for the creation and maintenance of political coalitions in support of on-going drug supply. The result is that the global AIDS treatment campaign becomes marked by mismatches of interests and capacities: those actors capable of taking the economic, legal, and political steps necessary to increase the supply and availability of essential drugs have diminished interest in doing so, and those actors with an interest in expanding treatment may lack the capacities to address the problem of undersupply. By focusing centrally on actors' interests in and capacities for economic and political action, the article restores political economy to analysis of an issue-area that has been dominated by attention to international law. And by examining the fragility of the coalitions supporting the production and supply of generic drugs, the article points to the limits of transnational activist networks as enduring agents of change. [source] | ||||||||||