Established Principles and New Developments in Good Pharmacovigilance Practices
Webcode 26112054
Dr. Eva Bauer
DREHM Pharma GmbH
Head of Medical Writing and Medical Affairs;
After studying biomedicine and biotechnology, Eva Bauer initially spent several years in research. During her PhD studies, her passion for writing deepened, which is why she has now been working as a medical writer and medical affairs manager for the Austrian consultancy DREHM Pharma GmbH for over 8 years. She is now head of the associated department and has not only accompanied numerous vigilance writing projects in her past, but has also spent several months as case manager.
More information please click here.
Anika Staack
ARC-Traicoa UG
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 pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regarding 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. Stefan Zohmann
DREHM Pharma GmbH
Joint Owner and CEO;
Stefan Zohmann joined the pharmacovigilance department of service provider DREHM Pharma in 2006 as a PSUR author and case manager. Since 2007 he has been working as a QPPV for numerous national and international companies and has set up pharmacovigilance systems of all sizes. In recent years, his focus has increasingly shifted towards auditing, from marketing authorisation holders to distributors and licensors. Stefan Zohmann is now Co-CEO and co-owner of DREHM Pharma.
More information please click here.
10 - 11/11/2026
10 - 11/11/2026
Both days: 09:00-17:00 CET
You can join 30 min before the course starts
online
online
Event - 2,090€ plus tax
The fee includes high-quality course material for download, a certificate of participation, access to our Learning Space and technical support, including a test meeting.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test incl certificate upon passing.
Event - 2,090€ plus tax
The fee includes high-quality course material for download, a certificate of participation, access to our Learning Space and technical support, including a test meeting.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test incl certificate upon passing.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
The Good Pharmacovigilance Practices (GVP) Modules published by the European Medicines Agency (EMA) are the key reference for pharmacovigilance practice in Europe. This two-day online course offers a comprehensive and practice-oriented refresher on established requirements, current updates, and recent developments across the GVP Modules.
The Good Pharmacovigilance Practices Modules (GVP Modules), published and regularly updated by the European Medicines Agency (EMA), set out the standards and measures for the effective fulfilment of pharmacovigilance responsibilities and serve as a key reference for drug safety in Europe.
Refresh and expand your knowledge of GVP in this course and apply what you learn directly in practical workshops. The course covers a broad range of topics, from pharmacovigilance systems in general to key documents such as the PSMF and PSURs, as well as quality and risk management.
Each topic is discussed in direct relation to the relevant GVP Modules, ensuring that all modules, including annexes, are thoroughly covered.
This online course will
08:45 - 09:00
09:00
FORUM
09:15
Dr Stefan Zohmann
10:00
Anika Staack
10:45 - 11:00 Coffee break
11:00
Dr Stefan Zohmann
11:45
Anika Staack
12:30 - 13:30 Lunch break
13:30
Dr Eva Bauer
14:15
Anika Staack
15:15 - 15:30 Coffee break
15:30
Dr Stefan Zohmann
16:00
Anika Staack
17:00 End of Day 1
09:00
Anika Staack, Dr Stefan Zohmann
09:15
Dr Stefan Zohmann
10:45 - 11:00 Coffee break
11:00
Anika Staack, Dr Stefan Zohmann
11:45
Anika Staack, Dr Stefan Zohmann
12:30 - 13:30 Lunch break
13:30
Dr Stefan Zohmann
14:15
Dr Stefan Zohmann
15:00 - 15:15 Coffee break
15:15
Anika Staack
16:45
Anika Staack, Dr Stefan Zohmann
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.
of 5 stars of all ratings from 2025
of 5 stars on Trustpilot = good
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All three speaker very knowledegable in their field of expertise and the topics, they presented. Mr. Zohmann and Ms. Staak provided for all topics their insights and practical approach, which is very helpful for daily PV business.
Dr. Nicole Leib
Fresenius Kabi Deutschland GmbH
04.07.2025
Fantastic 2 days of GVP-training with a lot of insights and full of content.
04.07.2025
Very well organized and overall an excellent training.
04.07.2025
