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EMA Information Day on Risk Management Planning


The focus of this Information Day will be on providing an update of ongoing Agency’s activities with regard to medicines’ risk management. This Risk Management Plan (RMP) Information Day will be an opportunity to provide marketing authorisation holders (MAHs) and marketing authorisation applicants (MAAs) practical advice on RMP drafting in view of the full implementation of the RMP revision 2 template after the transitional period has elapsed, as well as to interactively exchange experiences on the revision 2 RMP format between the regulators and industry.

The increasing number of biosimilars being authorised highlighted a need to better streamline the safety specification for biologicals so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. A dedicated session of the Information Day will also serve as a platform to discuss the streamlining of safety specification for biologicals with a special focus on biosimilars.

Updates on the work on the risk management aspects of the new GVP guidance on special populations such as children and elderly will be provided.

Other topics include risk communication as a key instrument for risk management coupled with the systematic publication of RMP summaries to ensure that the European system communicates risks effectively and in a timely and transparent manner.

The panel is happy to answer questions from the audience submitted to by 25 September 2018 latest.

Featured topics

  • GVP V rev.2  practical session – regulators and industry perspective on the implementation of the revised RMP template
  • Identifying safety concerns for biologicals and biosimilars
  • Update on new GVP guidelines in development (Paediatrics, Older people, Pregnancy and breastfeeding)
  • Risk communication

Who should attend?

  • Individuals involved in risk management planning, risk minimisation development and post authorisation safety studies at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)
  • Qualified Persons responsible for Pharmacovigilance (QPPVs)
  • Assessors at National Competent Authorities (NCAs)
  • Risk communication experts
  • Patients and Healthcare professional (HCP) group representatives

Program Committee

  • Zaide  Frias, PharmD
    Zaide Frias, PharmD Head of Human Medicines Evaluation Division
    European Medicines Agency, Netherlands
  • Sabine  Straus, MD, PhD, MSc
    Sabine Straus, MD, PhD, MSc PRAC Chair, Staff Member
    Medicines Evaluation Board (MEB), Netherlands
  • Jordi  Llinares Garcia, MS
    Jordi Llinares Garcia, MS Head of Scientific and Regulatory Management
    European Medicines Agency, Netherlands
  • Peter  Arlett, MD, FRCP
    Peter Arlett, MD, FRCP Head of Pharmacovigilance and Epidemiology Department
    European Medicines Agency, Netherlands
  • Marin  Banovac
    Marin Banovac Scientific Officer
    European Medicines Agency, Netherlands
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+41 61 225 51 51

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