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Virtual Event

02 nov 2020 1:00 p.m. - 04 nov 2020 4:25 p.m.

(Central Europe Standard Time)

4051 Basel, Switzerland

Pharmacovigilance Strategies Workshop

Session 8: Risk Minimisation Measures and Safety Communication

Session Chair(s)

Shahin  Kauser

Shahin Kauser

Leading Senior Scientific Assessor

MHRA, United Kingdom

Maarten  Lagendijk, MSc

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

Additional Risk Minimisation Measures (aRMM): Why do they matter?

Maarten Lagendijk, MSc

MSD, Netherlands

Deputy EU QPPV

Jan  Petracek, MD, MSc

Running Risk Minimisation Programs – Lessons Learned

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

Shahin  Kauser

Controlled Access Programmes

Shahin Kauser

MHRA, United Kingdom

Leading Senior Scientific Assessor

Inge  Zomerdijk, MSc

Measuring the Effectiveness of aRMM

Inge Zomerdijk, MSc

Medicines Evaluation Board (MEB), Netherlands

Pharmacovigilance Assessor

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