戻る Agenda
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
Senior Director, Teva Periodic Reports and Risk Management Centre