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.
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
Trusted by 375,005 students
Access to over 1.5 million titles for a fair monthly price.
Study more efficiently using our study tools.
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
Frequently asked questions
Yes, you can cancel anytime from the Subscription tab in your account settings on the Perlego website. Your subscription will stay active until the end of your current billing period. Learn how to cancel your subscription
No, books cannot be downloaded as external files, such as PDFs, for use outside of Perlego. However, you can download books within the Perlego app for offline reading on mobile or tablet. Learn how to download books offline
Perlego offers two plans: Essential and Complete
- Essential is ideal for learners and professionals who enjoy exploring a wide range of subjects. Access the Essential Library with 800,000+ trusted titles and best-sellers across business, personal growth, and the humanities. Includes unlimited reading time and Standard Read Aloud voice.
- Complete: Perfect for advanced learners and researchers needing full, unrestricted access. Unlock 1.5M+ books across hundreds of subjects, including academic and specialized titles. The Complete Plan also includes advanced features like Premium Read Aloud and Research Assistant.
We are an online textbook subscription service, where you can get access to an entire online library for less than the price of a single book per month. With over 1.5 million books across 990+ topics, we’ve got you covered! Learn about our mission
Look out for the read-aloud symbol on your next book to see if you can listen to it. The read-aloud tool reads text aloud for you, highlighting the text as it is being read. You can pause it, speed it up and slow it down. Learn more about Read Aloud
Yes! You can use the Perlego app on both iOS and Android devices to read anytime, anywhere — even offline. Perfect for commutes or when you’re on the go.
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
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 1.5 million books available in our catalogue for you to explore.