Organized and delivered in collaboration with the Dutch Medicines Evaluation Board (MEB), this face-to-face interactive training course covers the major pharmacovigilance processes as outlined in GVP I to XVI at intermediate level. The course provides in-depth training on post-market safety surveillance per EU Good Pharmacovigilance Practices. Topics cover expedited and periodic safety reporting, MedDRA coding and special situation reporting, PV quality systems (PSMF, QPPV, audits/inspections), signal detection/management, and risk management planning .

Other than lectures and exercises it gives a lot of room for interaction with the trainers and each other to ensure participants questions are answered. It is designed to strengthen foundation knowledge in all key aspects of European Post-Marketing Safety regulatory requirements for marketed products as well as marketed products in clinical trials.

Outcome: Participants gain a strong foundation in all key aspects of European PV requirements, able to describe reporting obligations in clinical development and post-market, implement robust PV quality systems, manage signals, and fulfill risk management duties. Furthermore, it includes highlights and updates on the pharmacovigilance legislation as well as the latest news on the ICH activities in pharmacovigilance.