Overview
This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
It is also possible to register for each of the 4 course modules separately:
Module 1: Definitions and Methods in Pharmacovigilance
Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
Module 3: Signal Detection and Management
Module 4: Risk Management
"Very well organized course that covered the basics of PV. Materials seemed good but I did not use them during the lectures because most of the presentations were interactive and the faculty was presenting their topics very well."
Martti Ahtola, PV Network Coordinator, European Pharminvent Services
"Very valuable! Useful insight of both regulator/ industry perspective & good cover across all areas of PV. Case studies & interactive examples were great to enhance understanding."
Program Committee
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Gaby L. Danan, MD, PhD Pharmacovigilance Expert
GLD, France -
Phil Tregunno Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
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