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How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End

Clinical Safety and Pharmacovigilance

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:

Room Number:



How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End

Judith Ulett Cope, MD, MPH
Medical Officer, Office of Pediatric Therapeutics, Office of the Commissioner
FDA, United States

This symposium will provide a background of federal legislation for FDA pediatric-focused safety reporting to FDA's Pediatric Advisory Committee (PAC). It will review why postmarketing safety assessments are crucial, how the FDA tracks and plans which products are reviewed, provides examples of why FDA would contact sponsors before PAC meetings and provide a summary of the past decade of reporting. The roles of IRBs and DSMBs will be examined and how they help ensure the safety of children in trials. Industry perspective is provided. The importance of long-term surveillance and registries will be reviewed.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Pediatric Safety Monitoring: Role of IRBs and DSMBs
Kathryn Bohannon
Theorem Clinical Research, Inc., United States

Pediatric Safety Monitoring: Industry Perspective
Christina Bucci-Rechtweg, DrMed, MD
Global Head, Pediatric and Maternal Health Policy
Novartis Pharmaceuticals Corporation, United States

Dianne Murphy, MD
Director, Office of Pediatric Therapeutics, OSMP, OMPT, OC
FDA, United States