This module is part of the learning path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)
M0 Pharmacovigilance Introduction and Basics
M1 Drug Safety Regulation and Good Pharmacovigilance Practices
M2 Pharmacovigilance and Drug Safety Operations
M3 Safety Medical Writing, Quality and Compliance
Why should I choose this course?
The course will be delivered by experienced trainers in the field who know the most critical aspects affecting PV employees firsthand. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach, our course will treat another different subject such as the international context of pharmacovigilance, and sources of information in pharmacovigilance, in order to document signal detection, ICSRs, PSURs, Referrals and more, presenting practical situations which may impact on daily activities. We will also be talking about the latest updates national and international guidance (FDA, EMA,…) for signal detection in pharmacovigilance, with practical examples of medical evaluation in signal management, focusing also on the issues most frequently encountered.