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EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

REGISTER EARLY! This Information Day is aimed at providing MAHs and MAAs with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.


Overview

The European Medicines Agency has published significant changes to EU pharmacovigilance guideline on risk management plans (GVP Module V and RMP Template Rev 2). These updates aim to further clarify the activities on which a risk management plan should focus to ensure optimal health promotion and protection based on a risk-proportionate planning of activities that directs resources to areas where the need for additional information and risk minimisation is greatest.
This Information Day is aimed primarily at providing marketing authorisation holders (MAHs) and marketing authorisation applicants (MAAs) with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.
Content requirements and procedural advice for RMP submission will be presented with practical examples provided, based on frequent questions from applicants, assessors, and EMA Risk Management Specialists. Highlights will include types of products with different legal basis application (e.g. generics, fixed dose combination products, biosimilars).

Feedback from the Industry will be discussed and EMA and PRAC view on topics raised will be provided.

The Q&A and panel discussion sessions will include the response to questions received in advance or raised during the presentations.


Participants are invited to send questions related to their experience with implementation of Rev 2 by 10 December to emaevents@diaglobal.org.


Featured topics

• Updates on risk management planning in the EU, with a focus on the recent revision of “Good Pharmacovigilance Guideline (GPV) Module V - Risk Management Systems”.
• RMP content requirements and practical advice on risk identification: new active substances, generics, biosimilars
• Procedural requirements for RMP updates
• Common elements in the RMP and PSUR safety specifications – building the justification for (re)classification of safety concerns

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), with a focus on medical writers building RMPs for new products or transitioning from Rev 1 to Rev 2 of the RMP Template
• Qualified Persons responsible for Pharmacovigilance (QPPVs)
• Assessors at National Competent Authorities (NCAs)
• Patients and Healthcare professional (HCP) group representatives

Program Committee

  • Enrica  Alteri, MD
    Enrica Alteri, MD Head, Human Medicines Research and Development Support Division
    European Medicines Agency, Netherlands
  • Emil Andrei  Cochino, MD, MHS
    Emil Andrei Cochino, MD, MHS Scientific Officer, Anti-infectives and Vaccines, SRM Department
    European Medicines Agency, Netherlands
  • Zaide  Frias, PharmD
    Zaide Frias, PharmD Head of Human Medicines Evaluation Division
    European Medicines Agency, Netherlands
  • Georgy  Genov, MD
    Georgy Genov, MD Head of Signal and Incident Management
    European Medicines Agency, Netherlands
  • Jordi  Llinares Garcia, MS
    Jordi Llinares Garcia, MS Head of Scientific and Regulatory Management
    European Medicines Agency, Netherlands
  • June Munro Raine, MD, MSc
    June Munro Raine, MD, MSc Chief Executive
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Sabine  Straus, MD, PhD, MSc
    Sabine Straus, MD, PhD, MSc PRAC Chair, Staff Member
    Medicines Evaluation Board (MEB), Netherlands
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+41 61 225 51 51


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Send Email
+41 61 225 51 51