Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices Review

Average Reviews:

(More customer reviews)written in a technically precise and easy-going manner, it covers well all items listed in the index. Allocation of tables and pictures sometimes far from the page one is reading, but no harm done. Overall it is an excellent book to align a team of RA professionals with the basics of the area.

Click Here to see more reviews about: Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

"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, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Get 15% OFF

Click here for more information about Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Read More...

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition Review

Average Reviews:

(More customer reviews)Amazon lists a 2003 paperback as 2nd edition and this hardback 2008 as "second edition." This hardback 2008 is clearly a later edition although both are so called second editions. Maybe the other should be called first edition, or maybe the mere fact the other was a paper back printing triggers a not-very-accurate second edition logo.
Well done book. The earlier (2003/2005) edition is available on kindle but not the 2008.
BQ

Click Here to see more reviews about: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.FDA Regulatory Affairs:provides a blueprint to the FDA and drug, biologic, and medical device developmentoffers current, real-time information in a simple and concise formatcontains a chapter highlighting the new drug application (NDA) processdiscusses FDA inspection processes and enforcement optionsincludes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDAThree all-new chapters cover:clinical trial exemptionsadvisory committeesprovisions for fast track

Click here for more information about FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

Read More...