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Pediatric Plans: The Challenges Between Regulations and Reality
Session Chair(s)
Darryl L'Heureux, PhD, MPharm, MSc
Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States
Clinical requirements children are different from adults and the strategy to implement a pediatric study has many challenges, in terms of ethical, operational, and scientific issues. Working with a uniquely vulnerable patient population provides additional complexity, with numerous regulatory requirements. The authoring of key documents to optimize pediatric drug development for regulatory approval is being integrated earlier in the drug development process. This forum features three speakers who will describe the current regulatory framework and changes in drug development in pediatric oncology, the challenges in safety reporting in pediatric clinical trials. and key documents that outline the strategy for developing a drug in pediatric patients.
Learning Objective : Describe the key regulations governing development of trials in pediatric patients; Describe the structure and required content of a PIP and a PSP; Identify changes in oncology development for pediatric patients and opportunities for scientific collaboration; Identify challenges for accurate safety reporting in pediatric clinical trials.
Speaker(s)
Regulatory Changes in Oncology Pediatric Trials
Mark W. Kieran, DrMed, MD, PhD
Bristol-Myers Squibb, United States
Clinical Trail Lead, Pediatrics Program Oncology Clinical Development
Solid Planning to Optimize Patient Safety and Clinical Outcomes
Judith A. Blacklidge, BSN, MSN, RN
ExecuPharm, Inc., United States
Clinical Quality Management
Key Documents For Pediatric Drug Development
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
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