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Session 2 -2
Session Chair(s)
Álmath Spooner, PHD
Director of Regulatory Policy and Intelligence
AbbVie, Ireland
This session will focus on the experience of the implementation and operation of the ICH E2C (R2) guideline on the “Periodic Benefit/Risk Evaluation Report (PBRER)” from regulators’ and industry perspective.
Speaker(s)
Experience with operation of the new PSUR assessment procedure at PMDA
Yoshihiko Sano
University of Tokyo, Indonesia
Graduate School of Pharmaceutical Sciences
Reflections from a pharmaceutical industry perspective on the implementation and operation of the new PBRER format
Laurent Auclert, MD
France
Pharmacovigilance Expert