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Wednesday, June 27 • 10:30am - 11:30am
#337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-646-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Earl Seltzer, MBA


Initiation and Development of Pediatric Clinical Trials: Regulatory and Ethical Issues
Donna L. Snyder, MD

DIY Toy Box: Operational Considerations and Insights for Pediatric Clinical Trials
Gina Calarco, BSN, MPH

avatar for Gina Calarco

Gina Calarco

Director of Pediatric Strategy and Planning, Covance
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics... Read More →
avatar for Donna Snyder

Donna Snyder

Senior Pediatric Ethicist and Team Leader, Office of Pediatric Therapeutics, OC, FDA
Donna L. Snyder, MD. MBE is the Senior Pediatric Ethicist and Team Leader in the Office of Pediatric Therapeutics (OPT) in the Office of the Commissioner (OC) at the US Food and Drug Administration (FDA). She is a standing member of the FDA Pediatric Review Committee (PeRC) and the... Read More →

Wednesday June 27, 2018 10:30am - 11:30am EDT
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Forum