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Millennium Chelsea Harbour Hotel

May 10, 2017 9:00 AM - May 11, 2017 5:30 PM

Chelsea Harbour, London, SW10 0XG, United Kingdom

Pharmacovigilance Conference

Pharmacovigilance Update: Practical Approaches to Current Challenges - Interactive Session and Workshop Series

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Session 7: Workshop on Risk Minimisation Measures and Effectiveness Evaluation

Session Chair(s)

Maarten Lagendijk, MSc

Maarten Lagendijk, MSc

Deputy EU QPPV, MSD, Netherlands

Inge Zomerdijk, MSc

Inge Zomerdijk, MSc

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands

This 2- part intensive workshop will look into detailed practices in risk minimisation and give insights to effectiveness evaluation from both regulator and industry perspective. Attendees will get an overview of the regulatory framework and learn about the tools that can be used in different situations. Practical considerations related to standardisation, patient and healthcare professional materials will be addressed and the difference between aRMM at authorisation and aRMM post-marketing will be discussed. Furthermore, the implementation in different countries, local requirements, harmonisation and convergence between authorities will be explored, effectiveness measurement discussed, and participants will debate at what degree and when implementation is completed.

Speaker(s)

Maarten Lagendijk, MSc

Session 7 - Quiz

Maarten Lagendijk, MSc

Deputy EU QPPV, MSD, Netherlands

Inge Zomerdijk, MSc

Implementation of risk minimisation measures

Inge Zomerdijk, MSc

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands

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