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Regulation of Medical Productsby John Griffin; John O'Grady
Blackwell Publishing Ltd. 2008; US$ 75.95A concise but comprehensive text explaining the processes involved in regulation of drugs with particular emphasis on EU, USA and Australia. more...
International Pharmaceutical Registrationby Alan A. Chalmers
Informa Healthcare 2000; US$ 299.95The increasing globalization of pharmaceutical markets and continuing consolidation within the pharmaceutical industry have highlighted the challenges of rapidly evolving regulatory requirements and created a much greater appreciation of the need for regulatory awareness throughout the industry. This book provides a practical overview and guide to the complexities of international pharmaceutical registration. With individual country chapters written by experts within that country drawn from regulatory authorities, international pharmaceutical companies, and regulatory consultants, the book comprehensively covers regulations across the globe. more...
The Law and Ethics of the Pharmaceutical Industryby M.N.G. Dukes
Elsevier 2005; US$ 170.00As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second... more...
International Trade and Health Protectionby T. Epps
Edward Elgar Publishing 2008; US$ 40.00Examines and critiques the WTO's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), asking whether it strikes an appropriate balance between conflicting domestic health protection and trade liberalization objectives. This book includes an historical overview of disputes over trade and health since the 1800s. more...
Global Regulatory Issues for the Cosmetics Industryby C.E. Betton
Elsevier 2007; US$ 140.00Global Regulatory Issues for the Cosmetics Industry more...
Intellectual Property Rights and Food Securityby M. Blakeney
CAB International 2009; US$ 170.00Intellectual Property Rights (IPRs) play an important role in the struggle for food security and encouraging agricultural research and development. This book examines these roles as well as the international relationship between IPRs, agricultural biotechnology, access to biological resources, food security and globalisation. more...
The Right to Food and the TRIPS Agreementby Hans Morten Haugen
BRILL 2007; US$ 382.00Analyses relationships between patent rights and human rights, focusing on the right to food. This book, using different techniques of assessing treaty conflict, analyses whether the TRIPS Agreement and the International Covenant on Economic, Social and Cultural Rights actually conflict. more...
Regulation of Functional Foods and Nutraceuticalsby Clare M. Hasler
John Wiley & Sons, Inc. 2008; US$ 245.00Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets. International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within... more...
Medical Product Regulatory Affairsby John J. Tobin; Gary Walsh
Wiley-VCH 2008; US$ 114.95"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." — Microbiology Today , May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers everything pharmacologists,... more...
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