Webcode 23032052
Dr. Martin Huber
Senior Expert Pharmacovigilance, Bonn, Germany
Senior Expert Pharmacovigilance German PRAC member
Dr. Sabine Jeck-Thole
Freelance Senior Safety Advisor, Switzerland
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, Germany
Principal Pharmacovigilance Writer;
Tiziana von Bruchhausen specialised over almost 15 years in pharmacovigilance and 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.
22/03/2023
22/03/2023
09:00-17:00 online-seminar You may d...
09:00-17:00 online-seminar You may dial in 30 min. before the session
online
online
Event - 1,190 € plus tax
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Event - 1,190 € plus tax
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Dr. Henriette Wolf-Klein
Conference Manager
+49 6221 500-680
h.wolf-klein@forum-institut.de
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
This seminar provides insights in particular into RMP and PSUR preparation, assessment and regulatory management.
After completing the online seminar, you will
This online seminar is intended for those working in the pharmaceutical industry already having profound knowledge of pharmacovigilance writing (with a focus on PSUR and RMP). QPPVs and people responsible for national pharmacovigilance are also invited to join the intensive discussion.
09:00
09:10
Dr Tiziana von Bruchhausen
09:40
Dr Tiziana von Bruchhausen, Dr Martin Huber
10:20
Dr Sabine Jeck-Thole, Dr Martin Huber
11:00 Coffee break
11:20
Dr Martin Huber
11:50
Dr Tiziana von Bruchhausen, Dr Sabine Jeck-Thole
12:20
Dr Tiziana von Bruchhausen
12:45 Lunch break
14:00
Dr Sabine Jeck-Thole
14:40 Coffee break
15:00
Dr Martin Huber
16:00
Dr Sabine Jeck-Thole
16:40
All speakers
17:00 Seminar ends
Overall impression: 100% of the participants’ feedback was very good or good. (March 2022)
Course content: 100% of the participants’ feedback was very good or good. (March 2022)
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Comments of participants (March 2020)
Since I am relatively new to the field, I wanted to learn more about RMP and PSUR life cycle management in general. I learned many things that I can use for my daily work. The seminar met my expectations.
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.
The great interactions.
This is what participants in (November 2018) liked most about the event.
Topics, interactive presentations.
