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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 1A: Workshop on Benefit-Risk Assessment in PSUR: Discussion on Practices

Session Chair(s)

Sarah Morgan

Sarah Morgan

Benefit-Risk Management Group Manager

MHRA, United Kingdom

Doris Irene Stenver, MD, MPA

Doris Irene Stenver, MD, MPA

Independent Pharmacovigilance Adviser

Unique Advice, Denmark

In the PSUR it is expected to provide a practical evaluation of the benefit-risk of the medicinal product. This evaluation is frequently given in general terms. How could we improve and present this assessment taking into consideration a competent authority and PRAC expectations?

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