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Pharmacovigilance and Risk Management Strategies Conference

Session 6: Clinical Trial Issues

    Session Chair(s)
      Annette  Stemhagen, DrPH, FISPE

      Annette Stemhagen, DrPH, FISPE

      • Senior Vice President, Safety, Epidemiology, Registries & Risk Management
      • 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).
      Sandra  Mitchell, PhD

      Use of Common Toxicity AE Terminology and Patient-Reported Outcomes in Clinical Trials

      Sandra Mitchell, PhD

      • Research Scientist & Program Director, Outcomes Research Branch
      • Division of Cancer Control and Population Sciences National Cancer Institute, United States
      Robert M Baker

      Global Harmonization of Pragmatic Safety Requirements, with Information from the Transcelerate Project

      Robert M Baker

      • Vice President, Global Patient Safety
      • Eli Lilly and Company, United States
      Sadiqa Hafeez Mian, MD, MPH


      Sadiqa Hafeez Mian, MD, MPH

      • Executive Medical Director, Head Safety Management
      • Amgen Inc., United States
      Michelle  Bulliard, BSN

      Implications of the Upcoming New EU Clinical Trials Regulation on Post-Authorization Safety Studies (PASS)

      Michelle Bulliard, BSN

      • Vice President, Global Head Real-World Evidence Strategy Unit
      • IQVIA, Switzerland