Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual

Dumitriu, Helene I.

ISBN 10: 1574910515 ISBN 13: 9781574910513

Casa editrice: CRC Press, 1997

Riassunto

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.

Su questo libro

Contenuti:

Chapters cover:
o Policy
o Auditing & Compliance
o Application for Clinical Trial License
o Application for Marketing Authorization
o Archiving Management
o Change Alert/Authorization Process
o Contact Report
o Contact with Regulatory Authority
o Crisis Management
o Documents for Regulatory Purposes
o Dossier
o Education/Training
o Electronic Submission
o Environmental Protection
o Global Dossier
o Import/Export
o Information Management
o Information Technology
o Inspection
o Labeling
o Outsourcing
o Periodic Safety Update Report (PSUR)
o Project Assignments
o Promotion/Advertising Compliance
o Regulations & Guidelines
o Regulatory Strategy
o Submission
o Terminology
o Tools

Product Description:

Brand New

Su questa edizione

• Editore: CRC Press
• Data di pubblicazione: 1997
• ISBN 10: 1574910515
• ISBN 13: 9781574910513
• Rilegatura: A fogli intercambiabili
• Numero edizione: 1
• Numero di pagine: 440