Pharmacovigilance System Master File MasterClass

Pharmacovigilance System Master File MasterClass shall describe the pharmacovigilance system and support/document its compliance with the requirements. As well as fulfilling the requirements for a PSMF laid down in the legislation and guidance.

Key Elements:

• Registration and Maintainance of the PSMF
• Contents and Information that should contain
• Format and Layout
• Change control and versions
• Archiving and Storage
• Responsabilities of the MAH