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European Medicines Agency

Apr 29, 2014 8:00 AM - Apr 29, 2014 5:00 PM

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

2nd Periodic Safety Update Report Information Day

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Session 2 -2

Session Chair(s)

Álmath Spooner, PhD

Álmath Spooner, PhD

Head of Europe Regulatory Policy & Intelligence (RPI)

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)

Yoshihiko Sano

Experience with operation of the new PSUR assessment procedure at PMDA

Yoshihiko Sano

University of Tokyo, Indonesia

Graduate School of Pharmaceutical Sciences

Laurent Auclert, MD

Reflections from a pharmaceutical industry perspective on the implementation and operation of the new PBRER format

Laurent Auclert, MD

France

Pharmacovigilance Expert

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