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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 - 1

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)

Jolanta Gulbinovic

Experience with operation of the new PSUR assessment procedure at the PRAC

Jolanta Gulbinovic

State Medicines Control Agency , Lithuania

Chief Expert in Drug Safety; PRAC Member

Christopher Turner, MD, FRCPC

Experience with operation of the new PSUR assessment procedure at Health Canada

Christopher Turner, MD, FRCPC

Health Canada / EMA, Canada

Director General

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