Core PSMF vs local annexes
Webcode 26062054
Dr. Petra Lerner-Hiller
Senior Expert Pharmacovigilance, Darmstadt, GERMANY
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, PV System & QPPV Relations Lead; Dr Petra Lerner-Hiller has more than 25 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs word-wide.
Stefanie Förster-Mathias
Merck Healthcare KGaA PSC Manager DACH and Graduated Plan Officer (Stufenplanbeauftragte)
PSC Manager DACH and Graduated Plan Officer (Stufenplanbeauftragte); After completing her degree in Biology, Ms Förster-Mathias began her career in pharmaceutical research in 2011 and moved into pharmacovigilance in 2015. She initially worked as a classical PV Manager before being appointed as Stufenplanbeauftragte, a role she still holds. She is now also PSC Manager DACH, responsible for pharmacovigilance and related compliance in Germany, Austria and Switzerland. Since 2019, Ms Förster-Mathias has additionally been an active member of the vfa, contributing to the Expert Group Patient Safety.
09/06/2026
09/06/2026
09:00-17:00 CEST
You may dial in 30 min before the course starts
online
online
Event - 1,290€ plus tax
The fee includes high-quality course material and a certificate for download, access to the Learning Space as well as technical support including a test meeting.
Event - 1,290€ plus tax
The fee includes high-quality course material and a certificate for download, access to the Learning Space as well as technical support including a test meeting.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
The PSMF is widely recognised and used worldwide. However, specific local requirements must be considered separately. In Europe, for example, some countries, such as France, mandate additional documents. Managing a core PSMF alongside local annexes is therefore becoming increasingly important and complex.
This seminar will provide you with the skills to develop, maintain, and optimise a global PSMF while integrating local requirements. You will gain valuable insights into regional regulations in the UK, France, the EAEU (Eurasian Union), and Arab countries. Benefit from the expertise of our Big Pharma professionals.
This online-seminar will make you knowledgeable about
08:45 - 09:00
09:00
FORUM Institut
09:15
Dr Petra Lerner-Hiller
10:30 - 10:45 Coffee break
10:45
Stefanie Förster-Mathias
12:30 - 13:30 Lunch break
13:30
Dr Petra Lerner-Hiller
14:45 - 15:00 Coffee break
15:00
Stefanie Förster-Mathias
16:00
Dr Petra Lerner-Hiller, Stefanie Förster-Mathias
17:00 End of course
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Overall impression: 100% of participants rated with 5 stars out of 5 stars (February 2024)
Practical benefit:100% of participants rated with 4 or 5 stars out of 5 stars (February 2024)
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It was very helpful and extensive, in particular with respect to local vs. global requirements. I liked the fact that the local PSMF requirements in different non-EU countries were presented seperately and in detail.
Well-structured course that provides insights and tips for good management of the PSMF according to all international and local regulations.
Informative, interactive, great group with lot of interessting questions.
Great preparation of the speakers and their ability to involve all the paticipants!
