This package includes: (You don’t need to purchase them individually)
- 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
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.
This Certification is designed for graduates who have a scientific background (MD, Pharm D, nurses, BAC in science/biologic,… aspiring to make a career in Pharmacovigilance / Drug Safety/Patient Safety