This specific ISBN edition is currently not available.View all copies of this ISBN edition:
"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.
"synopsis" may belong to another edition of this title.
"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)About the Author:
J.J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company employing several 100 people who develop and manufacture in vitro diagnostic reagents. Dr. Tobin therefore has extensive experience of working within an FDA and European medical device regulatory framework. Gary Walsh is a senior lecturer in industrial biochemistry at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical industry, as well as extensive teaching and non-laboratory based research interests in the pharmaceutical biotechnology arena. He has published a number of books, book chapters and journal articles relevant to this publication. He also teaches elements of pharmaceutical science and regulatory affairs on an annual course provided by the University of Limerick to an international medical device company with a manufactoring facility based in the region.
"About this title" may belong to another edition of this title.
Book Description Wiley-Blackwell, ., 2008. Hardcover. Condition: New. 1st Edition. Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. New. Seller Inventory # 000360
Book Description Wiley-VCH 2008-07-09, Weinheim :|Chichester, 2008. hardback. Condition: New. Seller Inventory # 9783527318773
Book Description Wiley VCH, 2008. HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FW-9783527318773
Book Description Condition: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Seller Inventory # ABOCT-52531
Book Description Condition: New. New. US edition. Perfect condition. Customer satisfaction our priority. Seller Inventory # ABE-SEP-113092
Book Description Condition: Brand New. New. US edition. Customer Satisfaction guaranteed!!. Seller Inventory # SHUB113092
Book Description Wiley-Blackwell, 2008. Hardcover. Condition: New. 1. Seller Inventory # DADAX3527318771
Book Description Condition: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship fro the US or other locations in India depending on your location and availability. Seller Inventory # AUOCT-52531
Book Description Condition: Brand New. New. US edition. Excellent Customer Service. Seller Inventory # ABEUSASEP19-113092
Book Description Vch Verlagsgesellschaft Mbh, 2008. Hardcover. Condition: Brand New. new edition. 260 pages. 9.50x6.75x0.75 inches. In Stock. Seller Inventory # __3527318771