Detection, evaluation and data processing in line with GVP Module IX
Webcode 26092052
Larissa Kopp
Expert in Pharmacovigilance and Signal Management, WHO-Consultant; Self-employed
With a background in biochemistry and molecular medicine, Larissa has specialised since 2020 in post-marketing safety assessment of vaccines, monoclonal antibodies and allergen products. She worked at the Paul-Ehrlich-Institut (PEI), Germany’s federal institute for vaccines and biomedicines, until April 2026, where she processed and analysed suspected adverse reaction cases, performed signal management and assessed safety reports. Today, Larissa is self-employed and works, among other roles, as a freelance consultant for the World Health Organization (WHO). In addition, she supports the international development and strengthening of pharmacovigilance systems, for example in Lesotho.
Dr. Ulrich Vogel
Boehringer Ingelheim International GmbH, Ingelheim
Head Strategic Data Analysis, Global Pharmacovigilance, Member CIOMS Working Group VIII, Practical Aspects of Signal Detection in Pharmacovigilance; Grounded in his training as a physician, Uli is focusing on transforming pharmacovigilance data into insights for medical risk identification and management. He acts as the global process owner for signal management and Head of the Safety Analytics and Data Science teams in pharmacovigilance. Uli is passionate about (visual) data communication and tailoring access to information in response to stakeholder demands. He is an active coder in R and D3.js and a member of CIOMS Working Group VIII "Practical Aspects of Signal Detection in Pharmacovigilance".
17 - 18/09/2026
17 - 18/09/2026
09:00-17:00 CE(S)T each day
You may dial in 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
In this interactive two-day seminar, you will explore signal management best practices using PRAC case studies and learn how to effectively leverage digital tools such as EudraVigilance, programmable data analysis and AI. Complementary perspectives from both the marketing authorisation holder and the former authority provide valuable insights for your day-to-day work.
Signal management is a core component of pharmacovigilance and is among the most frequent critical findings during inspections. In this seminar, you will learn how to fulfil regulatory requirements while keeping your processes efficient and lean.
On the first day, the focus is on the regulatory fundamentals and the signal management process. Step by step, the process is worked through and discussed based on practical PRAC examples.
The second day covers advanced topics such as communication with authorities, the use of EudraVigilance, data-driven analyses, digital automation and the role of artificial intelligence in signal management.
A special highlight: Benefit from two complementary viewpoints: The marketing authorisation holder (MAH) perspective from global pharmacovigilance practice and the regulatory perspective from a former assessor.
After attending this online seminar, you will...
08:45 - 09:00
09:00
FORUM Institut
09:15
Larissa Kopp
10:15
Both speakers
10:45 - 11:00 Coffee break
11:00
Larissa Kopp
12:00
Dr. Ulrich Vogel
12:45 - 13:45 Lunch break
13:45
Dr. Ulrich Vogel
14:45
Dr. Ulrich Vogel
15:15 - 15:30 Coffee break
15:30
Dr. Ulrich Vogel
16:00
Larissa Kopp
17:00 End of day 1
09:00
09:05
Dr. Ulrich Vogel
10:00
Larissa Kopp
10:45 - 11:00 Coffee break
11:00
Dr. Ulrich Vogel
12:00
Larissa Kopp
13:00 - 14:00 Lunch break
14:00
Larissa Kopp
14:30
Dr. Ulrich Vogel
15:00
Dr. Ulrich Vogel
15:15 - 15:30 Coffee break
15:30
Dr. Ulrich Vogel
16:45
Both speakers
17:00 End of the course
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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