UID:
almafu_9959328117702883
Format:
1 online resource (xiii, 283 pages) :
,
illustrations
ISBN:
9783527623044
,
3527623043
,
9783527644711
,
3527644717
Content:
"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.
Note:
Medical Product Regulatory Affairs; Contents; Preface; 1 The Aims and Structure of Regulations; 2 Regulatory Strategy; 3 Drug Discovery and Development; 4 Non-Clinical Studies; 5 Clinical Trials; 6 Marketing Authorisation; 7 Authorisation of Veterinary Medicines; 8 Variations to the Drug Authorisation Process; 9 Medical Devices; 10 Authorisation of Medical Devices; 11 Good Manufacturing Practice (GMP); 12 Oversight and Vigilance; Index.
Additional Edition:
Print version: Tobin, Jack (John J.). Medical product regulatory affairs. Weinheim : Wiley-Blackwell, ©2008 ISBN 9783527318773
Additional Edition:
ISBN 3527318771
Language:
English
Keywords:
Electronic books.
;
Electronic books.
;
Electronic books.
DOI:
10.1002/9783527623037
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9783527623037
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9783527623037
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9783527623037
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