
eBook - ePub
Medical Product Regulatory Affairs
Pharmaceuticals, Diagnostics, Medical Devices
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Medical Product Regulatory Affairs
Pharmaceuticals, Diagnostics, Medical Devices
About this book
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.
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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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh in PDF and/or ePUB format, as well as other popular books in Biological Sciences & Science & Technology Law. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Related title
- Title
- Copyright page
- 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