2026-03-19 2026-03-19 , online online, 1,290 € zzgl. MwSt. The Pharmacovigilance System Master File (PSMF) in a Global Environment

This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!

Themen
  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes: Practical hints and common pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight and duties of local PV officers


Who should attend
This course will be conducted in English.

This online seminar is valuable for anyone in the global pharmaceutical industry involved in the preparation and maintenance of the PSMF. It is aimed at both global and local PV functions.

Familiarity with the European PV framework is recommended for participants.
Ziel der Veranstaltung
The PSMF is widely recognised and used worldwide. However, specific local requirements must be considered separately. In Europe, for example, some countries, such as France, mandate additional documents. Managing a core PSMF alongside local annexes is therefore becoming increasingly important and complex.

This seminar will provide you with the skills to develop, maintain, and optimise a global PSMF while integrating local requirements. You will gain valuable insights into regional regulations in the UK, France, the EAEU (Eurasian Union), and Arab countries. Benefit from the expertise of our Big Pharma professionals.
Teilnehmerkreis

This online-seminar will make you knowledgeable about

  • the regulatory requirements and the responsibilities for the content and maintenance of a global PSMF .
  • how to structure a core PSMF.
  • the local peculiarities that must be addressed in the PSMF and what the local annexes should contain.
  • how to effectively manage the PSMF lifecycle on a global scale.

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

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

Core PSMF vs local annexes

Benefits
  • Create a stable core PSMF
  • Practical, first-hand expertise
  • Includes workshop "Global PSMF - Dos and don'ts"
  • Certified to ISO 9001 and ISO 21001 standards

Webcode 26062054

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Alles auf einen Blick

Termin

09/06/2026

09/06/2026

Zeitraum

09:00-17:00 CE(S)T
You may dial in 30 min before the course starts

09:00-17:00 CE(S)T
You may dial in 30 min before the course starts
Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Event - 1,290€ plus tax
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test including a certificate upon passing.

Event - 1,290€ plus tax
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test including a certificate upon passing.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!

Themen

  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes: Practical hints and common pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight and duties of local PV officers


Who should attend
This course will be conducted in English.

This online seminar is valuable for anyone in the global pharmaceutical industry involved in the preparation and maintenance of the PSMF. It is aimed at both global and local PV functions.

Familiarity with the European PV framework is recommended for participants.

Ziel der Veranstaltung

The PSMF is widely recognised and used worldwide. However, specific local requirements must be considered separately. In Europe, for example, some countries, such as France, mandate additional documents. Managing a core PSMF alongside local annexes is therefore becoming increasingly important and complex.

This seminar will provide you with the skills to develop, maintain, and optimise a global PSMF while integrating local requirements. You will gain valuable insights into regional regulations in the UK, France, the EAEU (Eurasian Union), and Arab countries. Benefit from the expertise of our Big Pharma professionals.

Teilnehmerkreis

This online-seminar will make you knowledgeable about

  • the regulatory requirements and the responsibilities for the content and maintenance of a global PSMF .
  • how to structure a core PSMF.
  • the local peculiarities that must be addressed in the PSMF and what the local annexes should contain.
  • how to effectively manage the PSMF lifecycle on a global scale.