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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.

Chair

Earl Seltzer, MBA

Speaker

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



Speakers
avatar for Gina Calarco

Gina Calarco

Director, Operational Strategy and Planning, Rare Disease and Pediatric Team, 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

Pediatric Ethicist and Team Lead, Office of Pediatric Therapeutics, OC, FDA
Donna L. Snyder, MD, FAAP, is currently Pediatric Ethicist and Pediatric Ethics Team Lead in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. She is board certified in Pediatrics and a Fellow of the American Academy of Pediatrics... Read More →


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