Helene I Dumitriu

Good Drug Regulatory Practices

A Regulatory Affairs Quality Manual

• Broschiertes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 440
• Erscheinungstermin: 2. Dezember 2019
• Englisch
• Abmessung: 254mm x 178mm x 23mm
• Gewicht: 762g
• ISBN-13: 9780367448080
• ISBN-10: 0367448084
• Artikelnr.: 58440024

Autorenporträt

Dumitriu, Helene I.

Inhaltsangabe

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