Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

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John Wiley & Sons, Sep 2, 2008 - Science - 297 pages
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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.
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 dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
 

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Contents

Preface XIII
6
Regulatory Strategy
21
Medical Product Regulatory Affairs John J Tobin and Gary Walsh
43
NonClinical Studies
57
Clinical Trials
73
Authorisation of Veterinary Medicines
129
Medical Devices
167
Authorisation of Medical Devices
187
Good Manufacturing Practice GMP
209
Oversight and Vigilance
237
Index
277
Copyright

Other editions - View all

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical ...
John J. Tobin,Gary Walsh
Limited preview - 2011

Common terms and phrases

according action active administration adverse animals Annex application appropriate approval assessment biological body changes Chapter Class clinical trials Code Committee Competent Authorities conducted contain Directive distribution documents drug drug product effects efficacy ensure equipment establish European evaluation example existing facilities Figure final guidance human identified indications initial inspection intended investigations involved issues labelling maintained manufacturing marketing authorisation materials measures medical devices medicinal products Member methods operations outlined packaging patient performance person pharmaceutical Phase practice prevent principles procedures proposed protocol quality system records reference regulations regulatory relating relevant requirements residues responsible risk safety samples shown specific sponsor Stability standards studies subjects submission submitted substance Summary Table testing therapeutic Title treatment validation veterinary medicinal

About the author (2008)

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.

Bibliographic information

QR code for Medical Product Regulatory Affairs
TitleMedical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
AuthorsJohn J. Tobin, Gary Walsh
Editionillustrated
PublisherJohn Wiley & Sons, 2008
ISBN3527318771, 9783527318773
Length297 pages
Subjects ›  › 

Science / Life Sciences / Cell Biology
Science / Life Sciences / Microbiology
  
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