2nd Periodic Safety Update Report Information Day

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Session 3: Periodic Benefit Risk Evaluation Reporting in practice

Session Chair(s)

Enrica Alteri, MD

Head, Human Medicines Research and Development Support Division

European Medicines Agency, Netherlands

This session will focus on the main objectives of the PBRER with regard to the optimisation and effective use of medicines and will provide an overview of the expectations of the PRAC as regards the presentation of signals and the risk assessment. Practical suggestions on content optimisation will be highlighted from an industry perspective.

Speaker(s)

Periodic Benefit Risk Evaluation Reporting: industry perspective

Klaudija Marijanovic Barac, MD

Teva, Croatia (Hrvatska)

Senior Director, Teva Periodic Reports and Risk Management Centre

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