John J.Tobin,GaryWalsh
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
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- Condition: Brand new
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- More about Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Medical Product Regulatory Affairs is a comprehensive and practical guide to medical regulatory affairs for professionals involved in bringing new products to market. It covers drug development, regulatory strategy, manufacturing license application and retention, and regulation in the USA, EU, and other major global markets. The Second Edition includes new EU regulations on the safe use of medical devices.
Format: Hardback
Length: 336 pages
Publication date: 11 October 2023
Publisher: Wiley-VCH Verlag GmbH
Medical Product Regulatory Affairs is a comprehensive and practical guide for professionals involved in bringing new products to market. It provides a hands-on approach to navigating the complex jungle of medical regulatory affairs across major global markets. The Second Edition of this book builds upon the success of the first, expanding its scope to cover new EU regulations on the safe use of medical devices.
The book begins with an overview of drug development, followed by comprehensive sections dedicated to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics covered include CDER, CBER, marketing and manufacturing licenses, the ICH process, and Good Laboratory/Clinical/ Manufacturing Practices.
Medical Product Regulatory Affairs offers valuable information on various aspects of regulation, including the aims and structure of regulation, regulatory strategy, drug discovery and development, non-clinical studies, clinical trials, and FDA communications. The wide coverage of different product types and the main global markets makes this book an essential resource for anyone involved in the pharmaceutical and medical devices industry.
Whether you are a regulatory professional, a scientist, a marketer, or a business executive, Medical Product Regulatory Affairs provides you with the knowledge and tools you need to ensure the successful development and commercialization of medical products in compliance with global regulations.
Weight: 790g
Dimension: 176 x 255 x 22 (mm)
ISBN-13: 9783527333264
Edition number: 2 ed
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