戻る Agenda
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
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Scientific Challenges for Post-Authorisation Safety and Efficacy Studies
Corinne de Vries, PHD, MA, MSC
European Medicines Agency, Netherlands
EMA liaison official to the US FDA
In the World of Expedited Pathways, will PAES and PASS substantiate Benefit-Risk?
Ryan Dean Kilpatrick, PHD
AbbVie, United States
Global Head, Epidemiology
PASS – Is the Ongoing Surveillance a Blessing or a Curse?
Magdalena Matusiak, MPHARM
KCR SA, Poland
Manager, Clinical Development; Pharmacovigilance Team Lead