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Session 6: Clinical Trial Issues
Session Chair(s)
Annette Stemhagen, DrPH, PHD, FISPE
Chief Science Officer, UBC, United States
The current regulatory framework and expectations for good pharmacovigilance practices are changing in key markets, which create new challenges for all stakeholders. This session will examine the expanding importance of patient perspectives on tolerability as the safety profile of an investigational product is developed. In addition, progress on global harmonization of pragmatic safety requirements will be addressed, and the impact of changes in clinical trial regulations on design of Post Authorization Safety Studies (PASS).
Speaker(s)
Sandra Mitchell, PHD
Research Scientist & Program Director, Outcomes Research Branch, Division of Cancer Control and Population Sciences National Cancer Institute, United States
Use of Common Toxicity AE Terminology and Patient-Reported Outcomes in Clinical Trials
Robert M Baker
Deputy Chief Medical Officer, Eli Lilly and Company, United States
Global Harmonization of Pragmatic Safety Requirements, with Information from the Transcelerate Project
Sadiqa Mian, MD, MPH
Executive Medical Director, Head Safety Management, Amgen Inc., United States
Speaker
Michelle Bulliard, BSN
Vice President, Global Head Real-World Evidence Strategy Unit, IQVIA, Switzerland
Implications of the Upcoming New EU Clinical Trials Regulation on Post-Authorization Safety Studies (PASS)