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
98% of 2017 course participants would recommend this course to a colleague or a friend
"I would like to praise Jan Petracek and Gaby Danan for their knowledge and enthusiasm transformed in presentation."
Maja Vovk, PV coordinator, Medis d.o.o., Slovenia
"Very good course, a lot of materials with explanations and examples, the faculty members were excellent, the organisation was brilliant and the venue was very appropriate. Great! Thank you!"
Iliyana Mitova, Pharmacovigilance Assistant, Pharma Support Services Ltd., Bulgaria
"I really liked the presentation skills of Jan Petracek, even though I was less familiar with the topics presented by him, they were presented in a very clear, transparent manner. I did not get bored during the presentation and found the topics very interesting."
"Very good presentation skills of the knowledgeable experts."
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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