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Virtual

Dec 10, 2025 1:00 PM - Dec 10, 2025 5:30 PM

(Central Europe Standard Time)

Risk Management Information Day

This live virtual information day is structured to transition from conceptual discussions to practical applications, focusing on the key themes of GVP Module XVI rev 3.

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Overview

Revision 3 of Good pharmacovigilance practices (GVP) Module XVI has been in effect in the EU for over a year. The guideline describes a lifecycle approach in development, execution and evaluation of risk minimisation measures (RMMs) to ensure their effective implementation.

The programme committee has structured this interactive Risk Management Information Day to transition from conceptual discussions to practical applications, focusing on the key themes of GVP Module XVI rev 3 and providing practical solutions to support their application.

Ample time is foreseen for Q&A. The faculty invites participants to submit questions by 26 November 2025 latest to emea.meetings@diaglobal.org.

Featured topics

  • Determining the key themes of revision 3 of GVP Module XVI
  • Practical solutions to support application of GVP Module XVI
  • Understanding the impact of implementation science on RMM effectiveness

Who should attend?

This virtual live information day is designed for:

  • Individuals experienced in risk management and RMM development and evaluation at small to medium enterprises (SMEs)
  • Marketing authorisation applicants (MAAs)/marketing authorisation holders (MAHs) for generic products
  • Marketing authorisation applicants (MAAs)/ marketing authorisation holders (MAHs) for innovator products
  • Contract Research Organisations (CROs)
  • Assessors at National Competent Authorities (NCAs)
  • Risk communication experts
  • Patients and Healthcare Professional (HCP) group representatives
  • Qualified persons responsible for Pharmacovigilance (QPPVs)

Need Approval in Order to Attend?

Download and fill out our justification letter to advocate to your supervisor why this is a must-attend event.

 

Download letter (CLICK HERE)

Program Committee

  • Robert Massouh, MPharm, RPh
    Robert Massouh, MPharm, RPh Head of Safety (PV) Risk Management and Benefit/Risk Evaluation
    GSK, United Kingdom
  • Priya Bahri, PhD, RPh
    Priya Bahri, PhD, RPh Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
    European Medicines Agency, Netherlands

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