Good Drug Regulatory Practices

A Regulatory Affairs Quality Manual

Helene I. Dumitriu (Autor)

Buch | Hardcover

440 Seiten

1997
Crc Press Inc (Verlag)
978-1-57491-051-3 (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

Erscheint lt. Verlag	30.9.1997
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	970 g
Themenwelt	Sachbuch/Ratgeber ► Gesundheit / Leben / Psychologie
ISBN-10	1-57491-051-5 / 1574910515
ISBN-13	978-1-57491-051-3 / 9781574910513
Zustand	Neuware