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Training Overview

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.

Learning Outcomes:

  • RMP Structure – Learn all the details about the RMP structure and compilation
  • Risk Minimization – Discover the risk minimization measures
  • Signal Management – Get to know the EU Guidelines and the authorities expectation on Signal Management
  • EVDAS – Have a closer look at the signal detection and the MAH experience in EVDAS

Who should attend?

  • Individuals involved in risk management planning, risk minimization development, and post-authorization safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
  • Risk communication experts
  • Qualified Persons responsible for Pharmacovigilance (QPPVs)
  • Individuals involved in pharmacovigilance, safety database, signal management and information management

Trainer

DIMITRIS ZAMPATIS
DIMITRIS ZAMPATISAssociate Director, Signal and Risk Management Process at Merck Biopharma

Download the Agenda

Download detailed Agenda - Risk & Pharmacovigilance MasterClass