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How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End
Session Chair(s)
Judith Ulett Cope, MD, MPH
Lead Medical Officer in the Office of Biostatistics and Epidemiology, CBER
FDA, United States
Pediatric Safety Monitoring: Role of IRBs and DSMBs
Learning Objective : Determine which FDA-regulated products are covered by legislation to have pediatric-focused safety reviews with presentation to FDA’s PAC; Explain why postmarket surveillance of adverse events in the pediatric population is crucial in identifying safety signals which were not identified in clinical trials; Discuss the role of IRBs and DSMBs; Discuss pharmaceutical product safety surveillance and risk management planning for products used in children.
Speaker(s)
Pediatric Safety Monitoring: Role of IRBs and DSMBs
Kathryn Elaine Bohannon
Syneos Health, United States
Senior Vice President, General Medicine
Pediatric Safety Monitoring: Industry Perspective
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Panelist
Mary Dianne Murphy, MD
FDA, United States
Director, Office of Pediatric Therapeutics, Office of Special Medical Programs
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