The Pharmacovigilance System Master File (PSMF) in a Global Environment

The PSMF is now used and recognised worldwide. Nevertheless, relevant local peculiarities have to be presented separately. There are even additional documents within Europe. Therefore, the creation and maintenance of a core PSMF and the local annexes is becoming
increasingly important and challenging.
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This online-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
#responsibilities for content and maintenance of the PSMF worldwide

Themen

- Concept of a global PSMF
- Structure and content of a core PSMF
- Local annexes - practical hints and pitfalls
- Effective maintenance: Impact assessment,
ad-hoc updates and change control
- QPPV oversight vs. local PV officer