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Session 8: Risk Minimisation Measures and Safety Communication
Session Chair(s)
Shahin Kauser
Leading Senior Scientific Assessor, MHRA, United Kingdom
Maarten Lagendijk, MSC
Deputy EU QPPV, MSD, Netherlands
Revision 2, of GVP Module XVI, provide guidance use of additional risk minimisation measures including the selection tools and their evaluation of their effectiveness. Additional risk minimisation measures include educational materials, controlled access programmes and controlled distribution systems. This session will explore some examples of such measures and the measurement of effectiveness to help stimulate discussion. There will be perspectives from Industry and the UK regulatory agency. In addition to hearing from the speakers, attendees will be encouraged to share their experience as part of the Panel Discussion.
Speaker(s)
Maarten Lagendijk, MSC
Deputy EU QPPV, MSD, Netherlands
Additional Risk Minimisation Measures (aRMM): Why do they matter?
Jan Petracek, MD, MSC
CEO, iVigee Services a.s., Czech Republic
Running Risk Minimisation Programs – Lessons Learned
Shahin Kauser
Leading Senior Scientific Assessor, MHRA, United Kingdom
Controlled Access Programmes
Inge Zomerdijk, MSC
Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands
Measuring the Effectiveness of aRMM