According to GVP Module XVI (Rev 3) and Addenda I and II
Webcode 26122052
Dr. Martin Huber
-requested- Senior Expert Pharmacovigilance
Head of Pharmacovigilance; Head of "PRAC, Legal Classification, Adverse Reaction Reporting, Medication Safety (AMTS)" and former PRAC Member; Dr. Huber is a pharmacist and public health professional with many years of experience spanning clinical practice, public administration, and committee work. After completing his studies and spending three years at Zurich University Hospital, he has worked in public administration since 2010. He has been a delegate to the Pharmacovigilance Risk Assessment Committee (PRAC) since 2012 and served as its Deputy Chair from 2018 to 2024. In addition, he chairs the CMDh Task Force on non-prescription medicines. Dr. Huber is an associate member of the Drug Commission of the German Medical Association (AkdÄ) and is active in several professional societies, including ISoP, DGRA, DPhG, and DGPPN.
Angela Schmidt-Mertens
Eisai GmbH
EU QPPV & General Safety Officer; Angela Schmidt-Mertens is a specialist physician with over 25 years of experience in pharmacovigilance and drug safety. Since 2019, she has been serving as the EU-QPPV and General Safety Physician at Eisai. Previously, she held senior roles at Boehringer Ingelheim and Sanofi and was Head of Drug Safety at UCB Pharma. In addition, since 2020, she has been actively engaged with the Drug Safety Subcommittee of the German Association of Research-Based Pharmaceutical Companies (VfA). Her expertise includes conducting pharmacovigilance audits, and she served for many years as Chair of the Drug Safety Committee at the German Medicines Manufacturers' Association (BAH).
04/12/2026
04/12/2026
09:00-17:00 CET
You may dial in 30 min before the course starts
online
online
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.
Nadja Wolff
Konferenzmanagerin Pharma & Healthcare
+49 6221 500-696
n.wolff@forum-institut.de
In this online seminar, you will learn how to design, implement and evaluate effectively (additional) risk minimisation measures ((a)RMMs). You will gain a clear understanding of current regulatory expectations based on GVP Module XVI (Rev 3) and Addenda I and II, and learn how (a)RMMs are selected, developed and monitored in practice.
This compact online seminar provides a comprehensive overview of modern risk minimisation in the context of patient safety and pharmacovigilance. You will gain a solid understanding of the practical application of the current regulatory framework, defined in:
After attending, you will:
08:45 - 09:00
09:00
09:15
Dr Martin Huber
10:15
Dr Martin Huber
10:45 - 11:00 Coffee break
11:00
Angela Schmidt-Mertens
12:00
Angela Schmidt-Mertens
12:30 - 13:30 Lunch break
13:30
Dr Martin Huber
14:30
Angela Schmidt-Mertens
15:00 - 15:15 Coffee break
15:15
Dr Martin Huber
15:45
Angela Schmidt-Mertens
16:45
Both speakers
17:00 End of seminar
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