The advanced course in Risk Management
Webcode 26012050
Dr. Martin Huber
-requested- Senior Expert Pharmacovigilance, Bonn, GERMANY
Senior Expert Pharmacovigilance German PRAC member
Anika Staack
ARC-Traicoa UG, Überlingen, GERMANY
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 held positions of increasing responsibility for the past 15 years in the pharmaceutical industry, with extensive experience in the clinical research operations sector. Anika holds a Master of Science degree in biology from Marburg University.
More information please click here.
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, GERMANY
Principal Pharmacovigilance Writer;
Dr Tiziana von Bruchhausen began her career in pharmacovigilance in 2008. Over the years, she has worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies, held various roles in contract research organisations, and worked as a freelance safety writer.
Currently serving as Principal Pharmacovigilance Writer at Boehringer Ingelheim, her responsibilities encompass both pre- and post-submission activities. These include global strategic planning and the preparation of key PV documents such as RMPs, PSURs, or DSURs.
Dr von Bruchhausen is also an active member of the European Medical Writers Association (EMWA). Since 2017, she has chaired the Pharmacovigilance Special Interest Group Committee. Additionally, she served as EMWA's President elect from 2017 to 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? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!
This seminar deepens your knowledge in RMP and PSUR preparation, assessment and regulatory management.
The updated GVP Module XVI - Risk minimisation measures (Rev 3) came into force on 6 August 2024. The FORUM Institute and our speakers guarantee that we will incorporate all updates into the training in an understandable way!
By attending this seminar, you will refresh your knowledge of the current European guidelines according to EMA Modules V and XVI. You will also learn new aspects of safety concerns and best practices for additional risk minimisation measures.
Take a look at pharmacovigilance documents from a QPPV perspective and benefit from our speakers' many years of experience with global authorities or in writing and harmonising RMP and PSUR!
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
12:15 - 13:15 Lunch break
13:15
Dr Tiziana von Bruchhausen
13:45
Anika Staack
14:15
Anika Staack
15:00 - 15:15 Coffee break
15:15
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.
of 5 stars of all ratings from 2024
of 5 stars on Trustpilot = good
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Necessary PV documents, contents and a medical writing checklist as a short overview.
Details
Many abbreviations are used in all regulatory areas. Download the list of the most important ones.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
Details
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.
The interaction between speakers and the content was very lively.
Great interactions.
Open atmosphere for discussions.
