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Has the New Format PSUR/PBRER Achieved What Was Originally Intended?
Session Chair(s)
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety
Eli Lilly and Company Ltd, United Kingdom
With the implementation of the European Good Pharmacovigilance Regulation and adoption of ICH E2C (R2), the content and purpose of the periodic safety update report (PSUR) has fundamentally changed. Increasingly, the periodic benefit-risk evaluation report (PBRER) is accepted by regulatory authorities around the world as the acceptable format for the PSUR. This session will review the process for developing the PBRER, lessons learned and discuss the impact of the PBRER on managing the benefit risk balance of medicines.
Learning Objective : Discuss practical implications of applying the new PSUR format to ensure an integrated approach to benefit risk analysis; Identify effective strategies for signal and risk evaluation, benefit evaluation and integrated benefit-risk analysis; Recognize what increased transparency of PSUR outcomes means for stakeholders; Describe the impact of the PBRER on managing benefit risk of medicines post-approval.
Speaker(s)
Update from the ICH E2C (R2) Expert Working Group
Álmath Spooner, PhD
AbbVie, Ireland
Director of Regulatory Policy and Intelligence
Almost Three Years On, Has the New Periodic Safety Update Report (PSUR) Achieved What Was Originally Intended?
Shelley Gandhi, MSc
Eliquent Life Sciences, United Kingdom
Partner & PV trainer
Global Perspective
William Gregory, PhD
Pfizer Inc, United States
Senior Director, Safety and Risk Management