The Pharmacovigilance System Master File (PSMF) in a Global Environment - Core PSMF vs local annexes: Dos and Don'ts

The PSMF is now used and recognised
worldwide. Nevertheless, relevant local
peculiarities have to be presented sepa-
rately. There are even additional docu-
ments within Europe. Therefore, the
creation and maintenance of a core
PSMF and the local annexes is becoming
increasingly important and challenging.

This seminar will make you knowledgeable
about:
- the regulatory requirements for a global
PSMF;
- how to structure a core PSMF;
- the local peculiarities that need to be
presented in the PSMF and what the
local annexes should look like;
- how to effectively design life cycle
management worldwide; and
- responsibilities for content and
maintenance of the PSMF worldwide.