This training course will provide a unique insight into the functioning of the EU Pharmacovigilance Risk Assessment Committee (PRAC) and advice on how best to interact with this important committee. The focus will be on the procedures covered by the PRAC mandate, in particular on safety referrals, data sources in post-marketing surveillance and risk management and risk minimization. The program will also include new ways of generating evidence, surveillance in special populations and initiatives aiming at strengthening patient engagement. This interactive course is recommended for those who have some experience in pharmacovigilance and wish to develop their skills to enhance the safe and effective use of medicines.
Understand how the PRAC works
Get an overview of the comprehensive EU legislation, guidance and procedures
Explore data sources, signal detection and scientific methods utilized in post-authorisation surveillance
Gain detailed knowledge of the complex referral procedure
Discuss and work on a safety referral procedure