Proceedings of the Third International Conference on Harmonisation PDF Download

Author: Kevin Daimi
Publisher: Springer Nature
ISBN: 3031655222
Category :
Languages : en
Pages : 794

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Author: Patrick Francis D'Arcy
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1090

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Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9789051995008
Category : Drugs
Languages : en
Pages : 108

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Book Description
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.

Author: Gary L. Evink
Publisher:
ISBN:
Category : Corridors (Ecology)
Languages : en
Pages : 448

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Author: Christian Tietje
Publisher: BRILL
ISBN: 9004181563
Category : Business & Economics
Languages : en
Pages : 1105

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Book Description
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.

Author: Richard K. Rondel
Publisher: John Wiley & Sons
ISBN: 9780471983293
Category : Medical
Languages : en
Pages : 386

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Book Description
Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 0470745916
Category : Medical
Languages : en
Pages : 492

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Book Description
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.

Author: John P. Griffin
Publisher: John Wiley & Sons
ISBN: 047098726X
Category : Medical
Languages : en
Pages : 883

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Book Description
New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia

Author: Gary Edmond
Publisher: Routledge
ISBN: 1351937723
Category : Law
Languages : en
Pages : 340

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Book Description
This collection of essays examines the multi-faceted roles of experts and expertise in and around contemporary legal and regulatory cultures. The essays illustrate the complexity intrinsic to the production and use of expert knowledge, particularly during transition from specialist communities to other domains such as policy formulation, regulatory standard setting and litigation. Several themes pervade the collection. These include the need to recognize that: expert knowledge and opinion is often complex, controversial and contested; there are no simple criteria for resolving disagreements between experts; appeals to 'objectivity' and 'impartiality' tend to be rhetorical rather than analytical; contests in expertise are frequently episodes in larger campaigns; there are many different models of expertise and knowledge; processes designed to deal with expert knowledge are unavoidably political; questions around who is an expert and what should count as expertise are not always self-evident; and the evidence rarely 'speaks for itself'.

Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 9780120455553
Category : Medical
Languages : en
Pages : 566

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Book Description
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.