Good Drug Regulatory Practices

A Regulatory Affairs Quality Manual

Helene I. Dumitriu (Autor)

Buch | Softcover

440 Seiten

2019
CRC Press (Verlag)
978-0-367-44808-0 (ISBN)

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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.

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in your company.

Dumitriu, Helene I.

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

Erscheinungsdatum	03.12.2019
Verlagsort	London
Sprache	englisch
Maße	178 x 254 mm
Gewicht	453 g
Themenwelt	Sachbuch/Ratgeber ► Gesundheit / Leben / Psychologie
Themenwelt	Naturwissenschaften ► Biologie
ISBN-10	0-367-44808-4 / 0367448084
ISBN-13	978-0-367-44808-0 / 9780367448080
Zustand	Neuware