Detection, evaluation and data processing in line with GVP Module IX
Webcode 26092052
Larissa Kopp
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Langen, GERMANY
Paul-Ehrlich-Institut (PEI); After completing her studies in Biochemistry and Molecular Medicine, Larissa Kopp specialised in the safety assessment of vaccines, monoclonal antibodies, and allergen products, primarily post-marketing authorisation. Her main responsibilities include processing and analysis of cases of suspected adverse events, signal management and the assessment of safety reports. She is also a member of the Global Advisory Committee on Vaccine Safety (GACVS) of the World Health Organization (WHO) and supports the development of pharmacovigilance systems internationally as part of the work of the WHO and EMA.
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 online seminar, you will learn best practices in signal management based on PRAC case examples and discover how to use digital tools such as EudraVigilance, programmable data analysis and artificial intelligence effectively. The complementary perspectives of competent authority and marketing authorisation holder provide valuable insights for your daily practice.
Signal management is a central component of pharmacovigilance and is among the most frequent critical findings during inspections. In this seminar, you will learn how to fulfil regulatory requirements reliably while designing your processes in an efficient and lean way.
On the first day, the focus is on the regulatory foundations and the signal management process. Step by step, the process is worked through and discussed based on practical case examples, including PRAC cases.
The second day is dedicated to more advanced topics such as communication with authorities, the use of EudraVigilance, data driven analyses, digital automation and artificial intelligence in signal management.
A particular highlight: the alternating perspectives of marketing authorisation holder and authority provide well founded insights from both sides, which is also a valuable addition for experienced professionals.
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
15:15 - 15:30 Coffee break
15:30
16:45
Both speakers
17:00 End of the training 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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