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

• 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

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.

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

This online-seminar will be of benefit to all those in the pharmaceutical industry involved in preparing and maintaining the PMSF in accordance with product changes and new requirements. A good knowledge of the European PV framework is recommended.