2023-11-28 2023-11-28 , online online, 1,190 € zzgl. MwSt. Heike von Treichel https://www.forum-institut.de/seminar/24022051-the-pharmacovigilance-system-master-file-psmf-in-a-global-environment/referenten/24/24_02/24022051-course-global-psmf_von-treichel-heike.jpg 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.

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


Who should attend
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.
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 help you to create an optimal PSMF and also to maintain and further develop it.
Your benefit

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.

Course Global PSMF

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

Core PSMF vs local annexes: Dos and Don'ts

Benefits
  • Create a stable core PSMF
  • Practical, first-hand expertise
  • Excellent networking possibilities
  • We are following the IMI quality criteria

Webcode 24022051

Jetzt buchen

JETZT Buchen
Referenten

Heike von Treichel

Senior Expert Pharmacovigilance, Darmstadt, GERMANY

Senior Expert Pharmacovigilance

Ivana Vukic, MPharm

Senior Pharmacovigilance & Quality Expert, Munich, GERMANY

Senior Pharmacovigilance & Quality Exper

Alles auf einen Blick

Termin

26/02/2024

26/02/2024

Zeitraum



Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

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.

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


Who should attend
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.

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 help you to create an optimal PSMF and also to maintain and further develop it.

Your benefit

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.

Detailed programme


09:00

Introduction and technical warm-up

09:10

Heike von Treichel

Concept of a global PSMF
  • Expectations of competent authorities and PSMF inspection findings
  • GVP Module II requirements for the PSMF
  • Seven-day requirements

10:30 Coffee break


10:45

Ivana Vukic, MPharm

Core PSMF vs local annexes
  • Structure and content of a core PSMF
  • Local requirements for France, the EAEU (Eurasian Union), the Middle East and the UK
  • Global vs local requirements (overlap and discrepancies)
  • Creation of the PSMF
  • Practical tips and pitfalls

12:15 Lunch


13:30

Heike von Treichel

QPPV oversight
  • Which QPPVs and local PV officers need to be involved?
  • Who is responsible overall?
  • Update planning and coordination and collaboration of contributors

14:45 Coffee break


15:00

Ivana Vukic, MPharm

Effective maintenance of a global PSMF
  • Body text vs. annexes
  • Impact assessment and quality control
  • Management of ad hoc updates
  • Change control, logbook, versions and archiving

16:00

Both speakers

Workshop: Global PSMF - Dos and don'ts

17:00 End of seminar


Information

Pre-meeting and technology check

Familiarise yourself with our Learning Space and gain the confidence you need by attending one of our free pre-meetings. No registration is required. You will find all the pre-meeting dates and the access information in your customer account. Pre-meeting meetings give you the opportunity to explore our Learning Space. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

Overall impression: 100% % of the participants’ feedback was very good or good. (February 2023)

Practical relevance: 100% of the participants’ feedback was very good or good. (February 2023)

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Your feedback produced as result of 1.8 in 2022. Thank you!

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More on our quality criteria

Testimonials


Expected a basic overview, but this was exeeded. Great level of details covered.


All was perfect.


Great!!!


Informative, interactive day which has enabled me to improve my current.

Helen Burnell

Gilead Sciences International Ltd.


Fantastic! Interesting & informative.

Adele Sylvester

Gilead Sciences International Ltd.


Good group discussions and practical tips.

Kseniia Kozlova

Berlin-Chemie AG

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