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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.

The participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management session, pragmatic approaches, real-life examples, lessons learned, as also processes for signal management and eRMR assessment will be discussed.

During this training, an outlook of the interactions between Drug Safety and other internal (e.g. Regulatory Affairs) and external stakeholders (health Authorities) will be given. How we communicate efficiently signals, Emerging safety issues (ESISs), and other safety communications (i.e. DHPCs) will be discussed.

Learning Outcomes:

  • New GVP Guidelines – Update on new GVP guidelines for special populations
  • PV Practice Module IX – Good Pharmacovigilance Practice Module IX on Signal Management
  • Safety Communication – Safety Communication: signals, Emerging Safety Issues and DHPCs to the regulatory authorities
  • GVP V rev.2 – GVP V rev.2– regulators and industry point of view of the implementation of the revised RMP template

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


DIMITRIS ZAMPATISScientific Director, Safety Strategy Lead at Merck Biopharma

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