International Pharmaceutical Product Registration, Second Edition

International Pharmaceutical Product Registration, Second Edition

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Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.... European Commission Enterprise and Industry Directorate-General, Unit F2, Pharmaceuticals Reference: Service Contract No: FIF.20040739 Submitted by ... Annex C. Template for EU Risk Management Plan (EU-RMP) EMEA/192632/ 2006 September 27th 2006. ... Geneva 2005. http://www. September 23, 2008.

Title:International Pharmaceutical Product Registration, Second Edition
Author:Anthony C. Cartwright, Brian R. Matthews
Publisher:CRC Press - 2009-08-26


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