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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)
Use of Common Toxicity AE Terminology and Patient-Reported Outcomes in Clinical Trials
Sandra Mitchell, PhD
Division of Cancer Control and Population Sciences National Cancer Institute, United States
Research Scientist & Program Director, Outcomes Research Branch
Global Harmonization of Pragmatic Safety Requirements, with Information from the Transcelerate Project
Robert M Baker
Eli Lilly and Company, United States
Deputy Chief Medical Officer
Speaker
Sadiqa Mian, MD, MPH
Amgen Inc., United States
Executive Medical Director, Head Safety Management
Implications of the Upcoming New EU Clinical Trials Regulation on Post-Authorization Safety Studies (PASS)
Michelle Bulliard, BSN
IQVIA, Switzerland
Vice President, Global Head Real-World Evidence Strategy Unit