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Course Global PSMF
PSMF in a global
environment
2020-02-13 2020-02-13 Hotel Frankfurt Messe (ehem. QGREENHOTEL by Meliá) Katharinenkreisel 60486 Frankfurt conference.qgreen.frankfurt@melia.com +49 69 70730-0 +49 69 70730-333

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

Core PSMF vs local annexes: Dos and Don'ts

This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
Topics
  • 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

This distinguishes our event

100%
Overall impression: % of the participants’ feedback was very good or good. (May 2019)

Aims and objectives

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 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.


Who should attend
This 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.
Your speakers
Mara Dinkel
PharmaLex GmbH, Friedrichsdorf, Germany

Heike von Treichel
Senior Expert Pharmacovigilance, Darmstadt, Germany


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