2023-12-04 2023-12-04 , online online, 1,190 € plus tax Heike von Treichel https://www.forum-institut.com/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

Book now

JETZT Buchen

Speakers

Everything at a glance

Appointment

26/02/2024

26/02/2024

Period

09:00-17:00; You may dial in 30 min....

09:00-17:00; You may dial in 30 min. before the session

Venue

online

online

Downloads

Fee

Inhouse-offers

Your contact

Course Global PSMF

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

09:00-17:00; You may dial in 30 min. before the session

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

100%

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

100%

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

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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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