Dr. Monica Buchberger
CENCORA Pharmalex GmbH, Bad Homburg vor der Höhe, GERMANY
Senior Director Pharmacovigilance, Head of PV Department Dr Monica Buchberger is a registered pharmacist with over 25 years' experience in the pharmaceutical industry in global and local roles and activities. She has extensive experience in regulatory affairs, drug safety and quality systems. She specialises in international pharmacovigilance and regulatory affairs legislation, mergers/acquisitions/spin-offs (portfolio integration and separation) and, as head of the PV department, management strategies.
Stephan Hütter
CENCORA PharmaLex GmbH, Mannheim, GERMANY
Director Global Program Management / Regional Lead LATAM
More information please click here.
04-05/12/2024
04-05/12/2024
Day 1: 09:00-17:00
Day 2: 09:00-13:00
You may dial in 30 min. before the session
online
online
Veranstaltung - 1,590 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,590 € 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
Outsourcing of activities, tasks or positions in regulatory affairs and pharmacovigilance is often standard practice. In this seminar, you will not only learn all you need to work with service providers, but also how to set up and monitor an effective vendor oversight programme in practice.
Outsourcing in pharmacovigilance (PV) and regulatory affairs (RA) is standard practice. But the main responsibility for ensuring that the services meet regulatory requirements remains with the marketing authorisation holder (MAH). This raises a number of questions, which our experts will answer.
This seminar will enable you to
08:45
09:00 Seminar begins
09:00 Welcome
09:15
Dr Monica Buchberger, Stephan Hütter
09:30
Dr Monica Buchberger, Stephan Hütter
10:45 Coffee break
11:00
Dr Monica Buchberger, Stephan Hütter
12:30 Lunch break
13:30
Dr Monica Buchberger
15:15 Coffee break
15:30
Dr Monica Buchberger
16:45
17:00 End of day one
09:00 Day two begins
09:00
Stephan Hütter
09:15
Stephan Hütter
11:00
Stephan Hütter
12:45
Stephan Hütter
13:00 Seminar ends
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