EU Pharmacovigilance & PRAC Procedures

This training course will provide a unique insight into the functioning of the EU Pharmacovigilance Risk Assessment Committee (PRAC) and advice on how to best interact with this important committee. The course will cover the procedures covered by the PRAC mandate, with focus on signal management, periodic safety update reports (PSUR), risk management plans (RMP), post-authorisation safety studies (PASS) and referrals. This interactive course is recommended for those who have some experience in pharmacovigilance and wish to further develop their skills to enhance the safe surveillance of medicines.