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Post-Authorisation Safety and Efficacy Studies: Scientific Challenges and Factors for Success
Session Chair(s)
Linda J. Scarazzini, MD, RPh
Vice President, Pharmacovigilance and Patient Safety, AbbVie, United States
The new EU pharmacovigilance legislation increased the focus on scrutiny of post-authorisation activities to assist in the ongoing benefit-risk evaluation of medicines. Post-Authorisation Safety Studies (PASS) play an increasingly important role in characterising and better understanding safety concerns and are now an integral part of understanding the effectiveness of risk minimisation measures. Post-authorisation efficacy study guidance is still under development but it is clear that design of these studies and PASS need to be scientifically robust in order that they achieve the desired objective as described in the legislation. This session will explore the scientific challenges that these requirements pose.
Speaker(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Corinne de Vries, PhD, MA, MSc
EMA liaison official to the US FDA, European Medicines Agency, Netherlands
Scientific Challenges for Post-Authorisation Safety and Efficacy Studies
Ryan Dean Kilpatrick, PhD
Global Head, Epidemiology, AbbVie, United States
In the World of Expedited Pathways, will PAES and PASS substantiate Benefit-Risk?
Magdalena Matusiak, MPharm
Manager, Clinical Development; Pharmacovigilance Team Lead, KCR SA, Poland
PASS – Is the Ongoing Surveillance a Blessing or a Curse?
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