The Pharmacovigilance System Master File (PSMF) in a Global Environment
Core PSMF vs local annexes
- Build and maintain a robust core PSMF that works across regions
- Understand what local annexes should contain
- Real-world examples, exercises, and online test
- Certified to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
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.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
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.
This one-day online seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
Your speakers
Dr. Petra Lerner-Hiller
Senior Expert Pharmacovigilance, Darmstadt
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, PV System & QPPV Relations Lead;
Dr Petra Lerner-Hiller has more than 25 years of experience in leading…
Your speaker
Dr. Petra Lerner-Hiller
Senior Expert Pharmacovigilance, Darmstadt
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, PV System & QPPV Relations Lead;
Dr Petra Lerner-Hiller has more than 25 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs worldwide.
Stefanie Förster-Mathias
Merck Healthcare KGaA
PSC Manager DACH and Graduated Plan Officer (German QPPV);
After completing her degree in Biology, Ms Förster-Mathias began her career in pharmaceutical research in 2011 and moved…
Your speaker
Stefanie Förster-Mathias
Merck Healthcare KGaA
PSC Manager DACH and Graduated Plan Officer (German QPPV);
After completing her degree in Biology, Ms Förster-Mathias began her career in pharmaceutical research in 2011 and moved into pharmacovigilance in 2015. She initially worked as a classical PV Manager before being appointed as Stufenplanbeauftragte, a role she still holds. She is now also PSC Manager DACH, responsible for pharmacovigilance and related compliance in Germany, Austria and Switzerland. Since 2019, Ms Förster-Mathias has additionally been an active member of the vfa, contributing to the Expert Group Patient Safety.
What to Expect
- 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.
The 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.
Objective of the Event
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 course 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.
Your Benefit
This training course 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.
Programme
09:00-17:00 CE(S)T
You may dial in 30 min before the course starts
08:45 - 09:00
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.
09:00
FORUM Institut
09:15
Dr Petra Lerner-Hiller
- GVP Module II requirements for the PSMF
- Seven-day requirements
- Expectations of competent authorities and PSMF inspection findings
10:30 - 10:45
10:45
Stefanie Förster-Mathias
- 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
12:30 - 13:30
13:30
Dr Petra Lerner-Hiller
- Which QPPVs and local PV officers need to be involved?
- Who is responsible overall?
- Update planning and coordination and collaboration of contributors
14:45 - 15:00
15:00
Stefanie Förster-Mathias
- Body text vs annexes
- Impact assessment and quality control
- Management of ad hoc updates
- Change control, logbook, versions, and archiving
16:00
Both speakers
17:00
08:45 - 09:00
Technical warm-up
Technical warm-up
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.
Welcome and Introduction
09:15
Concept of a global PSMF
Concept of a global PSMF
Dr Petra Lerner-Hiller
- GVP Module II requirements for the PSMF
- Seven-day requirements
- Expectations of competent authorities and PSMF inspection findings
Coffee break
10:45
Core PSMF vs local annexes
Core PSMF vs local annexes
Stefanie Förster-Mathias
- 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
Lunch break
13:30
QPPV oversight
QPPV oversight
Dr Petra Lerner-Hiller
- Which QPPVs and local PV officers need to be involved?
- Who is responsible overall?
- Update planning and coordination and collaboration of contributors
Coffee break
15:00
Effective maintenance of a global PSMF
Effective maintenance of a global PSMF
Stefanie Förster-Mathias
- Body text vs annexes
- Impact assessment and quality control
- Management of ad hoc updates
- Change control, logbook, versions, and archiving
Workshop: Global PSMF - Dos and don'ts
End of course
Downloads
Request the documents using our form.
Abbreviation list Pharmacovigilance
Link list: Drug Safety Navigator
Further Informations
Benefits of a FORUM Institut training course
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
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This is what distinguishes this event
The overall impression of the event was rated 4.3/5 stars.
(9 June 2026)
The practical benefits of the event were rated 4.0/5 stars.
(9 June 2026)
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