Legal foundations, core responsibilities, and practical application
Webcode 27022051
Dr. Tanja Peters
Bavarian Nordic GmbH
Head Global Clinical Safety and EU/UK/DE QPPV; Dr Peters is a clinical pharmacologist with over 25 years’ experience in the pharmaceutical industry across Research and Development, Regulatory Affairs and Pharmacovigilance, having held roles at Boehringer Ingelheim, Merck KGaA and Bavarian Nordic. As Deputy EU QPPV and Head of PV Intelligence at Boehringer Ingelheim, she implemented EU GVP and the global PSMF, and, in collaboration with regional PV organisations, established a PV intelligence network to analyse emerging pharmacovigilance requirements and translate them into local and global PV systems. Within Medical Safety, she championed the development of signal management, risk management and safety communications. She is particularly passionate about coaching and developing early-career talent. Dr Peters currently serves as Head of Global Drug Safety and EU/UK QPPV at Bavarian Nordic.
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG
Head of Global Pharmacovigilance, EU-QPPV, and local QPPV; Reinhold Schilling is a recognised expert in the field of pharmacovigilance, with over a decade of experience in drug safety and regulatory requirements. Holding dual master's degrees in Chemistry and Drug Regulatory Affairs, he has been heading the global drug safety department of Wörwag Pharma GmbH & Co. KG as Head of Global Pharmacovigilance since 2021. In addition to his work in industry, Reinhold Schilling is also active in academia, serving as a lecturer in pharmacovigilance at Reutlingen University and at the Goethe Business School. As an active member of the BPI Pharmacovigilance Working Group, he contributes his expertise to the further development of regulatory frameworks.
17 - 18/02/2027
17 - 18/02/2027
09:00 - 17:00 CET Both days
You may join 30 min before the session starts
online
online
Event - 2,090€ 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 with an additional certificate upon passing.
Event - 2,090€ 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 with an additional certificate upon passing.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
This two-day online course equips new, aspiring, and practising QPPVs with a clear understanding of their role under EU pharmacovigilance legislation, focusing on key responsibilities, strategic planning, and effective oversight. Learn what it takes to perform the role in practice while ensuring ongoing compliance.
The Qualified Person for Pharmacovigilance (QPPV) holds a pivotal role for every Marketing Authorisation Holder (MAH) in the EU, carrying significant responsibility and a wide range of duties.
This course provides concise and practical guidance on the QPPV's responsibilities, grounded in the relevant legal framework. Upon completion, you will have a clear understanding of the expectations and regulatory obligations associated with this role, and you will be equipped to apply this knowledge confidently in your daily work. Real-life case studies, practical exercises, and interactive workshops will help you to successfully transfer what you have learnt into professional practice.
This online course will...
08:45 - 09:00
09:00
FORUM Institut
09:15
Reinhold Schilling
10:45 Coffee break
11:00
Dr Tanja Peters
12:00
Reinhold Schilling
12:30 Lunch break
13:30
Reinhold Schilling
15:00 Coffee break
15:15
Both speakers
16:15
Dr Tanja Peters
16:45
Both speakers
17:00 End of Day 1
09:00
Both speakers
09:15
Reinhold Schilling
10:45 Coffee break
11:00
Dr Tanja Peters
11:45
Reinhold Schilling
12:30 Lunch break
13:30
Dr Tanja Peters
14:15
Reinhold Schilling
15:00 Coffee break
15:30
Dr Tanja Peters
16:00
Both speakers
16:45
Both speakers
17:00 End of the seminar
This course combines solid theoretical foundations with hands-on workshops and lively, interactive discussions. To help you get the most out of the online format, we kindly ask you to keep your camera on whenever possible and to participate actively in the discussions.
After the seminar, you may complete a multiple-choice test in our Learning Space to demonstrate your learning progress. All participants will receive a certificate of attendance. If you pass the test, you will also receive an additional certificate confirming successful completion of the course "The EU Qualified Person for Pharmacovigilance (EU QPPV)".
of 5 stars of all ratings from 2025
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The training was comprehensive and provided lots of hands-on advice. The instructors were very knowledgeable and had a lot of practical experience. I really liked it and would definitely recommend it to new and even seasoned QPPVs.
You gave us a lot of input and information about how to improve our PV system. Experienced speakers.
In-depth training, excellent information provided, prepares for a good theoretical knowledge.
Good overview, practical examples, working sessions, individual questions were answered.
Lots of practical items and clear message were provided, speakers were engaged and have a lot of know-how.
It gave an overall broad overview of tasks and responsibilities of QPPV/deputy QPPV. Good examples - practical advise - workshop!
