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Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally
Session Chair(s)
Earl Seltzer, MBA
Senior Director, Partnerships and Innovation
CTI, 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 : Evaluate and characterize the risk profile of pediatric clinical trials; Establish a realistic operational delivery strategy in light of the risk profile; Identify the medical, regulatory, and operational barriers to pediatric clinical trial feasibility on a global scale.
Speaker(s)
Initiation and Development of Pediatric Clinical Trials: Regulatory and Ethical Issues
Donna Snyder, MD
WCG, United States
Executive Physician
DIY Toy Box: Operational Considerations and Insights for Pediatric Clinical Trials
Gina Calarco, BSN, MPH
Covance, United States
Director of Pediatric Strategy and Planning
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