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Session 3 - 1
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 Report – has it achieved what it set out to do?
Álmath Spooner, PHD
AbbVie, Ireland
Director of Regulatory Policy and Intelligence
Presenting signal evaluations and presenting risk assessments in the PBRER – interdependencies with signal management
Menno Van Der Elst, PHARMD, PHD
MEB, Netherlands
Head of EU Committees Department
Practical suggestions to optimise content: industry perspective
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety