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OverviewWritten by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use. Full Product DetailsAuthor: Cheng Yee Lowe (Oxon, UK)Publisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 15.60cm , Height: 2.50cm , Length: 23.40cm Weight: 0.562kg ISBN: 9781574910643ISBN 10: 1574910647 Pages: 278 Publication Date: 28 February 1998 Audience: General/trade , General Format: Hardback Publisher's Status: Out of Print Availability: Out of stock  Table of ContentsIntroduction. The European Union. Pharmaceutical Legislation. Marketing Authorization. Registration Procedures. Abridged Applications. Variations. Renewals. Community Referral. Decision-Making Process. Appendices.ReviewsAuthor InformationLowe\, Cheng Yee Tab Content 6Author Website:Countries AvailableAll regions |
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