2023-02-02 2023-02-02 , online online, 1,190 € zzgl. MwSt. Mara Dinkel https://www.forum-institut.de/seminar/23022051-the-pharmacovigilance-system-master-file-psmf-in-a-global-environment/referenten/23/23_02/23022051-course-global-psmf_dinkel-mara.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
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 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
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.

Course Global PSMF

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

Benefits
  • Interactive online format
  • Practical, first-hand expertise
  • Excellent networking possibilities
  • We are following the IMI quality criteria

Webcode 23022051

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JETZT Buchen

Referenten


Alles auf einen Blick

Termin

27/02/2023

27/02/2023

Zeitraum

09:00-17:00 online-seminarYou may di...

09:00-17:00 online-seminar
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Henriette Wolf-Klein
Conference Manager

+49 6221 500-680
h.wolf-klein@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
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 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

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.

Detailed programme

09:00-17:00 online-seminar
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually

09:00

Introduction and technical warm-up

09:05

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

Mara Dinkel

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

Mara Dinkel

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


This distinguishes our events

Overall impression: 100% % of the participants’ feedback was very good or good. (February 2022)

Practical relevance: 100% of the participants’ feedback was very good or good. (February 2022)

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Quality guaranteed!

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