Advanced concepts for effective risk management
Webcode 26012050
Dr. Martin Huber
Senior Expert Pharmacovigilance, Bonn
Expert in Benefit-Risk Assessment in Pharmacovigilance and PRAC Member; Being a pharmacist by training as well as holding a Master of Public Health and spending three years at the University Hospital Zurich, Dr Huber has been working in the public sector since 2010. Since 2013, he has been responsible for PRAC-related matters, adverse reaction reporting, legal classification of medicines, and drug therapy safety. He has been the German delegate to the Pharmacovigilance Risk Assessment Committee (PRAC) since 2012 and served as its vice-chair from 2018 to 2024. Additionally, he is chair of the CMDh Task Force on non-prescription medicines and serves as the representative to the "Committee of Experts on the Classification of Medicines as Regards Their Supply" (CD-P-PH/PHO) at the EDQM. Dr Huber is an associate member of the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft - AkdÄ) and actively contributes to several professional societies, including ISoP, DGRA, DPhG, and DGPPN.
Anika Staack
ARC-Traicoa UG, Überlingen
Founder and PV Expert,
Consultant, EU-QPPV and local QPPV;
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining of pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regards to PV and also for PV inspections. Anika has been working in the pharmaceutical industry since 2003, holding positions of increasing responsibility. She has extensive experience in clinical research operations and holds a Master of Science degree in biology from Marburg University
More information please click here.
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim
Principal Pharmacovigilance Writer;
Tiziana von Bruchhausen started working in pharmacovigilance in 2008 and has gained extensive hands-on experience with the EU Pharma Package. She worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies, covering various roles in a contract research organization and as a freelance writer. She is currently working as a principal pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on RMPs, PSURs and their assessment reports.
Tiziana is an active volunteer at the European Medical Writers Association (EMWA), where she has been chairing the Pharmacovigilance Special Interest Group Committee since 2017. She was Vice President of EMWA in 2017-2018 and President in 2018-2019.
More information please click here.
29/01/2026
29/01/2026
09:00-17:00 CET
You may dial in 30 min before the session
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? In this course, you will enhance your practical skills in preparing, assessing, and managing RMPs and PSURs, and learn about the latest requirements of GVP Module XVI (Rev. 3) and the new Implementing Regulation (EU) 2025/1466.
This seminar will enhance your expertise in RMP and PSUR preparation, assessment, and regulatory management.
The updated GVP Module XVI "Risk Minimisation Measures (Rev. 3)" and the new "Implementing Regulation (EU) 2025/1466" have entered into force. Together with our expert speakers, FORUM Institut ensure that all recent updates are integrated into the training in a clear and comprehensible manner.
By participating, you will refresh your knowledge of the current European guidelines in line with EMA Modules V and XVI, while also gaining valuable insights into new safety concerns and best practices for additional risk minimisation measures.
You will explore pharmacovigilance documents from a QPPV perspective and benefit from our speakers’ extensive experience with global authorities, as well as in drafting and harmonising RMPs and PSURs.
After completing the online seminar, you will
08:45 - 09:00
09:00
FORUM Institut
09:15
Dr Tiziana von Bruchhausen
09:45
Dr Tiziana von Bruchhausen, Dr Martin Huber
10:30 - 10:45 Coffee break
10:45
Dr Tiziana von Bruchhausen, Dr Martin Huber
11:15
Anika Staack
11:45
Dr Martin Huber
12:00 - 13:00 Lunch break
13:00
Dr Tiziana von Bruchhausen
13:30
Anika Staack
14:00
Anika Staack
14:45 - 15:00 Coffee break
15:00
Dr Martin Huber
16:00
Anika Staack
16:45
All speakers
17:00 End of 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.
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation.
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My expectations were to have an open discussion on these matters and to check if we, as a company, are aligned with the other companies. these were fully met.
My initial expectations were about the identification of the important safety concerns according to the new GVP module V rev.2 and the identification of the additional PV activities and their possible effectiveness measures. All topics were discussed with a high level of detail.
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Great interactions.
Open atmosphere for discussions.
