Good Drug Regulatory Practices - A Regulatory Affairs Quality Manual

This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). It covers regulatory affairs regarding global product development for the European Union, Japan, and the United States.

List of contents

Part I: The Regulatory Affairs Quality System 1. Historical Overview 2. Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs 3. Check Your Quality System Part II: The Regulatory Affairs Quality Manual 4. The Quality Manual Explained 5. The Philosophy behind the Policies 6. Policies 7. Standards

About the author

Dumitriu, Helene I.

Summary

This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). It covers regulatory affairs regarding global product development for the European Union, Japan, and the United States.

Product details

• Authors: Helene I Dumitriu, Helene I. Dumitriu
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 02.12.2019
• EAN: 9780367448080
• ISBN: 978-0-367-44808-0
• No. of pages: 440
• Subjects: Guides > Health > Illnesses, therapies; Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine