Legal foundations, core responsibilities, and practical application
Webcode 26072052
Dr. Tanja Peters
Bavarian Nordic GmbH, GERMANY
EU/UK/DE QPPV and Head Global Clinical Safety and Pharmacovigilance ad interim; Dr Tanja Peters is a clinical pharmacologist with more than 25 years' experience in the pharmaceutical industry. Since 2025, she has been working at Bavarian Nordic as the EU and UK Qualified Person for Pharmacovigilance (QPPV) and as the company's Stufenplanbeauftragte (German Graduated Plan Officer). Previously, she held a range of positions spanning research and development, regulatory affairs, and pharmacovigilance at Merck KGaA and Boehringer Ingelheim. In her role as Deputy EU QPPV and Head of PV Intelligence at Boehringer Ingelheim, she led the implementation of EU Good Pharmacovigilance Practices (EU GVP), developed the company's Pharmacovigilance System Master File (PSMF), and, in collaboration with regional pharmacovigilance organisations, established a PV intelligence network to monitor, evaluate, and translate emerging pharmacovigilance requirements into local and global PV systems.
Reinhold Schilling
Wörwag Pharma GmbH & Co. KG, Böblingen, GERMANY
Head of Global Pharmacovigilance, EU-QPPV, 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.
01 - 02/07/2026
01 - 02/07/2026
09:00 - 17:00 CEST (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 online two-day 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 and ensure 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 actively participate in the discussions.
After the seminar, you can complete a multiple-choice test in our Learning Space to demonstrate your learning progress. Upon passing, you will receive a certificate of attendance and an additional certificate stating that you are an "EU Qualified Person for Pharmacovigilance (EU QPPV)".
of 5 stars of all ratings from 2025
of 5 stars on Trustpilot = good
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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!
