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Regulation of the pharmaceutical industry

Author: John Abraham; Helen Lawton Smith
Publisher: Houndmills, Basingstoke, Hampshire ; New York : Palgrave Macmillan, 2003.
Series: Studies in regulation.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Database:WorldCat
Summary:
This unique collection brings together the work of social scientists, ethicists, lawyers and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe and developing countries are discussed, including case studies of norplant, interferon and anti-fertility vaccines. The contributors analyse several key  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Regulation of the pharmaceutical industry.
Houndmills, Basingstoke, Hampshire ; New York : Palgrave Macmillan, 2003
(DLC) 2002032770
(OCoLC)50782411
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: John Abraham; Helen Lawton Smith
ISBN: 9780230372597 0230372597 6613960632 9786613960634 128364813X 9781283648134
OCLC Number: 759110535
Description: 1 online resource (x, 278 pages).
Contents: List of Tables and Figures --
Notes on the Contributors --
Acknowledgements --
Introduction; J. Abraham --
Regulatory Laws and Political Culture in the United States and Germany; A. Daemmrich --
Europeanization of Medicines Regulation; J. Abraham & G. Lewis --
Globalization of Medicines Control; J. Abraham & T. Reed --
Sales Licensing Documentation and Trade Secrecy: The Case of Norplant Contraceptives; E. Ollila & E. Hemminki --
Biological Medicines in the Age of Biotech: Public Policy Issues; N. Morris --
New Molecules, Markets and Changing Drug Regulatory Practices; T. Peters --
Users' Involvement in Regulating Contraceptive Innovation: The Design of Anti-Fertility Vaccines; J.van Kammen --
Regulations for Ethical Purposes: Medical Research on Humans; C. Foster --
The Limitations of Current Ethical Regulations; O. Corrigan --
Mergers and Joint Ventures in the Pharmaceutical Industry; H. Kelly & M. Hadden. Regulatory laws and political culture in the United States and Germany / Arthur Daemmrich --
Europeanization of medicines regulation / John Abraham and Graham Lewis --
Globalization of medicines control / John Abraham and Tim Reed --
Sales licensing documentation and trade secrecy : the case of Norplant[superscript R] contraceptives / Eeva Ollila and Elina Hemminki --
Biological medicines in the age of biotech : public policy issues / Norma Morris --
New molecules, markets and changing drug regulatory practices / Toine Pieters --
Users' involvement in regulating contraceptive innovation : the design of anti-fertility vaccines / Jessika van Kammen --
Regulation for ethical purposes : medical research on humans / Claire Foster --
The limitations of current ethical regulations / Oonagh Corrigan --
Mergers and joint ventures in the pharmaceutical industry / Helen Kelly and Morven Hadden.
Series Title: Studies in regulation.
Responsibility: edited by John Abraham and Helen Lawton Smith.
More information:

Abstract:

This unique collection brings together the work of social scientists, ethicists, lawyers and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe and developing countries are discussed, including case studies of norplant, interferon and anti-fertility vaccines. The contributors analyse several key dimensions of the debate: national political culture; the Europeanization of regulatory decision-making; the globalization of scientific standard-setting and intellectual property rights in drug development; the impact of industrial innovation strategies on regulatory practices' secrecy and public accountability of regulatory agencies; the regulatory influence of users on medical technology; the ethics of drug development and research and the oligopolization of the industry. This book will be of great interest to all those concerned about how pharmaceuticals and medical technologies should be developed and controlled.

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