Old and New in the Good Pharmacovigilance Practices
Webcode 24102053
Anika Staack
Consultant and ARC-Traicoa UG, Überlingen, Germany
Independent PV Expert, EU-QPPV and local QPPV; Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining of pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regards to PV and also for PV inspections. Anika has held positions of increasing responsibility for the past 15 years in the pharmaceutical industry, with extensive experience in the clinical research operations sector. Anika holds a Master of Science degree in biology from Marburg University.
Dr. Stefan Zohmann
DREHM Pharma GmbH, Vienna, AUSTRIA
Joint Owner and CEO
More information please click here.
Dr. Eva Bauer
DREHM Pharma GmbH, Vienna, AUSTRIA
Head of Medical Writing and Medical Affairs; After studying biomedicine and biotechnology, Eva Bauer initially spent several years in research. During her PhD studies, her passion for writing deepened, which is why she has now been working as a medical writer and medical affairs manager for the Austrian consultancy DREHM Pharma GmbH for over 8 years. She is now head of the associated department and has not only accompanied numerous vigilance writing projects in her past, but has also spent several months as case manager.
07-08/10/2024
07-08/10/2024
Both days: 09:00-17:00
You can dial in 30 min before the course starts
online
online
Event - 1,890 € plus tax
The fee includes high-quality course materials (also available for download), a certificate of participation, access to our Learning Space and technical support, including a test meeting.
Event - 1,890 € plus tax
The fee includes high-quality course materials (also available for download), a certificate of participation, access to our Learning Space and technical support, including a test meeting.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.
The Good Pharmacovigilance Practices modules (GVP modules), published and regularly updated by the European Medicines Agency (EMA), compile standard practices and measures to facilitate the execution of pharmacovigilance duties, serving as a key reference in European drug safety.
Update your knowledge of GVP in this course and apply what you learn directly in the practical workshops. A broad range of topics, from general pharmacovigilance systems to important documents like the PSMF and PSURs, as well as quality and risk management, await you.
This online course will
08:45
09:00
FORUM
09:15
Dr. Stefan Zohmann
10:00
Anika Staack
10:45 Coffee break
11:00
Dr. Stefan Zohmann
11:45
Anika Staack
12:30 Lunch
13:30
Dr. Eva Bauer
14:15
Anika Staack
15:15 Coffee break
15:30
Dr. Stefan Zohmann
16:00
Anika Staack
17:00 End of Day 1
08:45 Day 2 begins
09:00
Anika Staack, Dr. Stefan Zohmann
09:15
Dr. Stefan Zohmann
10:45 Coffee break
11:00
Anika Staack, Dr. Stefan Zohmann
11:45
Anika Staack, Dr. Stefan Zohmann
12:30 Lunch
13:30
Dr. Stefan Zohmann
14:15
Dr. Stefan Zohmann
15:00 Coffee break
15:15
Anika Staack
16:45
Anika Staack, Dr. Stefan Zohmann
17:00 End of course
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