戻る Agenda
Session 2 - 1
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 the PRAC
Jolanta Gulbinovic
State Medicines Control Agency , Lithuania
Chief Expert in Drug Safety; PRAC Member
Experience with operation of the new PSUR assessment procedure at Health Canada
Christopher Turner, MD, FRCPC
Health Canada / EMA, Canada
Director General