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Vol 21 No 10 Oct/Nov 2016

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Regulatory Data Protection in the Pharmaceuticals Industry

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ISBN13: 9780752006680
ISBN: 0752006681
Published: December 1999
Publisher: Sweet & Maxwell Ltd
Country of Publication: UK
Format: Hardback
Price: Out of print



This Special Report clearly explains the principles of data exclusivity and the complex law surrounding this fast-changing area of intellectual property. Of special relevance to the pharmaceutical and biotech sectors, the work examines the legislative framework and recent case law to provide the practitioner with a comprehensive guide to maximising the protection of test data and data generated from clinical trials. * The only detailed study of this rapidly developing area * A one-stop guide, including commentary as well as legislative and case law materials * Important international perspective, comparing the legal regime in key jurisdictions.

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Contents:
Narrative: the legal regimes in Europe, the US, Australia, New Zealand and the rest of the world. Appendices: legislation and case law.