Risk & Pharmacovigilance MasterClass

The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor’s point of view in evaluating an RMP. On the second day participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools, as also on the EMA pilot phase using Eudravigilance Data Analysis System (EVDAS). Finally, during this training, an outlook of current and future challenges in pharmacovigilance focusing on the impact of the coming into force of the General Data Protection (GDPR) Regulation in May 2018 will be given and discussed.

The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor’s point of view in evaluating an RMP. On the second day participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools, as also on the EMA pilot phase using Eudravigilance Data Analysis System (EVDAS). Finally, during this training, an outlook of current and future challenges in pharmacovigilance focusing on the impact of the coming into force of the General Data Protection (GDPR) Regulation in May 2018 will be given and discussed.