Download or read book Proceedings of the First International Conference on Harmonisation written by and published by . This book was released on 1992 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Transnational Economic Governance Regimes written by Christian Tietje and published by BRILL. This book was released on 2009-10-14 with total page 1105 pages. Available in PDF, EPUB and Kindle. Book excerpt: Non-governmental organizations, transnational business associations, private standard-setting bodies, public-private partnerships, and institutionalized incentive schemes now occupy a central place in the regulation and governance of transnational economic affairs alongside states and intergovernmental organizations. Much of the literature on these new and emerging patterns of governance has focused on the legal, political, and normative implications of this rapidly evolving landscape. The Handbook of Transnational Economic Governance Regimes expands on this scholarship by identifying, describing, and analysing more than 85 of the most significant actors in transnational governance. The Handbook examines the origins, evolution, structure, membership, financing, and strategies of key organizations and regulatory networks in almost every sphere of global economic activity, and analyses their role and influence in contemporary transnational economic governance.

Download or read book Focus on Pharmaceutical Research written by José Luis Valverde and published by IOS Press. This book was released on 1999 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Commission's Fifth Framework Programme for Research and Technological Development (1998-2002) has been recently launched. As often the case with new programmes, the time allows for a careful evaluation of the work concluded in the previous programme. This volume, the first in a series on Pharmaceuticals, policy and law, takes stock of the experience gathered in the field of pharmaceutical research in the BIOMED 2 Programme of the EU Fourth Framework Programme(1994-1998) , and attempts an analysis of the needs, opportunities and perspectives in the field from the various points of view of the academia, pharmaceutical industry, regulatory authorities, consumers and patients, including those suffering from rare diseases. The case for a robust system for pharmacovigilance in modern pharmacotherapy and underpinning research is defended.

Download or read book Proceedings of the Second International Conference on Harmonisation written by Patrick Francis D'Arcy and published by . This book was released on 1994 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Download or read book The Handbook of Transnational Governance written by Thomas Hale and published by John Wiley & Sons. This book was released on 2018-02-12 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: When we speak of global governance today, we no longer mean simply state-to-state diplomacy, international treaties, or intergovernmental organizations like the United Nations. Alongside these ‘traditional' elements of global politics are a host of new institutions ranging from global networks of governmental officials, to private codes of conduct for corporations, to action-oriented partnerships of NGOs, governments, corporations, and other actors. These innovative mechanisms offer intriguing solutions to pressing transnational challenges as diverse as climate change, financial governance, workers' rights, and public health. But they also raise new questions about the effectiveness and legitimacy of transnational governance. An expanding body of scholarship has sought to identify and assess these new forms of governance, but this young body of work has lacked a sense of the larger picture. This volume seeks to fill that need by presenting a comprehensive overview of new forms of transnational governance. This resource is essential for those who want to explain why transborder governance has changed and to understand what implications these changes have for global politics.

Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Download or read book The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines written by S.R. Walker and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.

Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2001 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Download or read book Regulating Medicines in Europe written by John Abraham and published by Routledge. This book was released on 2014-04-04 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms Volume 4 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2010-11-09 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: These OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries and some non members associated with the work.

Download or read book Translational Medicine written by Dennis Cosmatos and published by CRC Press. This book was released on 2008-12-17 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in

Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms Volume 2 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2006-07-24 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: These OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries.

Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.