Core PSMF vs local annexes
Webcode 25012052
Dr. Petra Lerner-Hiller
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, and QPPV Relations Lead, Darmstadt, GERMANY
Dr Petra Lerner-Hiller has more than 20 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 Quality and QPPV Relations Lead, responsible for pharmacovigilance quality management and audits and communication with local QPPVs.
Ivana Vukic, MPharm
Senior Pharmacovigilance & Quality Expert, Munich, GERMANY
Senior Pharmacovigilance & Quality Expert
23/01/2025
23/01/2025
09:00-17:00 CET
You may dial in 30 min before the course starts
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.
Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, 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 now widely used and accepted globally. However, specific local requirements must be addressed separately. There are even additional documents required within Europe, such as in France. The creation and maintenance of a core PSMF and local annexes is therefore becoming increasingly important and challenging.
This seminar will equip you with the skills to create, maintain, and optimise an effective PSMF. You will also gain insights into the specific requirements of the EU, French, EAEU, and Arab PSMFs. Benefit from the expertise of our Big Pharma professionals.
This online-seminar will make you knowledgeable about
08:45 - 00:00
09:00
09:10
Dr Petra Lerner-Hiller
10:30 Coffee break
10:45
Ivana Vukic, MPharm
12:15 Lunch
13:30
Dr Petra Lerner-Hiller
14:45 Coffee break
15:00
Ivana Vukic, MPharm
16:00
Dr Petra Lerner-Hiller, Ivana Vukic, MPharm
17:00 End of course
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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Necessary PV documents, contents and a medical writing checklist as a short overview.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
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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!
