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DIA 2018 Global Annual Meeting


Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally

    Session Chair(s)
      Earl  Seltzer, MBA

      Earl Seltzer, MBA

      • Director, Global Feasibility-Site and Patient Access
      • Syneos Health, United States
    Planning for pediatric trials requires a deep understanding of the regulatory, medical, and operational aspects of study conduct in order to ensure these trials are conducted as sufficient as possible. This session will include members of a CRO and developer space.
    Learning Objective : Understand the ethical considerations and regulatory requirements when enrolling pediatric patients in research studies. Discuss pediatric extrapolation of efficacy from adult data and when it is appropriate. Describe the level of evidence needed to initiate studies in the pediatric population, including instances when the disease is rare, and the condition does not occur in adults.
    Speaker(s)
      Donna L. Snyder, MD

      Initiation and Development of Pediatric Clinical Trials: Regulatory and Ethical Issues

      Donna L. Snyder, MD

      • Pediatric Ethicist and Team Lead, Office of Pediatric Therapeutics, OC
      • FDA , United States
      Gina  Calarco, BSN, MPH

      DIY Toy Box: Operational Considerations and Insights for Pediatric Clinical Trials

      Gina Calarco, BSN, MPH

      • Associate Director, Pediatric Center of Excellence
      • IQVIA, United States