Strategies for successful PV (remote) inspections in Germany, Europe and worldwide
Webcode 25032052
Angela Hartmann
Senior Expert Pharmacovigilance, Darmstadt, GERMANY
Audit, Inspection, Deviation and CAPA Manager Ms Hartmann has many years of experience in drug safety in international pharmaceutical companies, including case handling, process management, pharmacovigilance database management, global literature research, clinical trials, audits and inspections.
Per-Holger Sanden
Merck Healthcare KGaA, Darmstadt, GERMANY
Inspection Management Lead Per-Holger Sanden is an experienced and dedicated physician with extensive expertise in pharmaceutical quality assurance and process optimisation. He has been Head of Inspection Management at Merck Healthcare KGaA for almost eight years, where he coordinates over 160 inspection teams worldwide in the areas of GCP, GVP and GLP. A pragmatic troubleshooter and adept mediator, he brings not only his extensive expertise but also his passion for quality risk management and computer system validation.
Dr. Kimberley Sherwood
-requested- Senior Expert Pharmacovigilance, Bonn
Senior Expert Pharmacovigilance
24/03/2025
24/03/2025
09:00-17:30 CET
You may dial in 30 min before the session
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
Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.
To ensure that marketing authorisation holders comply with their pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specified intervals. This online course provides an insight into current (remote) pharmacovigilance inspection strategies.
This seminar will equip you to prepare for pharmacovigilance inspections professionally, adhering to legal requirements and best practices.
Engage with experts from authorities and industry to discuss your questions and find the answers you need.
After the seminar, you will gain a thorough understanding of current pharmacovigilance inspection strategies and be able to enhance your processes in Germany, Europe and worldwide.
08:45
09:00
FORUM Institut
09:15
Dr Kimberley Sherwood
09:45
Per-Holger Sanden
10:45 Coffee break
11:00
Per-Holger Sanden
11:45
Per-Holger Sanden, Angela Hartmann
12:15 Lunch break
13:00
Per-Holger Sanden, Angela Hartmann
13:30
Dr Kimberley Sherwood
14:30
Per-Holger Sanden, Angela Hartmann
15:45 Coffee break
16:00
Angela Hartmann
16:30
All speakers
17:15
17:30 Seminar ends
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Necessary PV documents, contents and a medical writing checklist as a short overview.
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We provide flexible education and training with high-quality e-Learning programmes for several topics.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
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All speakers provided excellent content and explanation of the content.
Very useful to get an overview of the procedure.
Good & clear training in pharmacovigilance inspection readiness. Clear and very good speakers.
Bita Mangin
Sanofi Aventis Groupe, Paris
Practical examples related to PV inspection requests.
Sharing of examples from recent experiences.
Possibility to hear from other companies about their inspection experiences.
