Identifying and mitigating risks in pediatric protocol development: Strategies, tools & access planning

Achieving equal access to medical treatment for children requires strategic planning and regulatory insight. Pediatric clinical development presents unique risks and challenges that are often difficult to manage, particularly when resources are limited.

In this webinar, presenters will explore the regulatory strategies and tools needed to ensure pediatric access to medical treatment, focusing on Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs), which are key components in aligning pediatric and adult treatment pathways.

The webinar will also introduce the Pediatric Risk Assessment Map (PRAM), an interactive, reusable tool developed by ICON’s Centre for Pediatric Clinical Development (CPCD). Designed to fill gaps in pediatric-focused resources, PRAM helps confirm, quantify, and assess risks at any stage of a pediatric-inclusive program.

Register now to reserve your spot and gain practical insights into risk mitigation and regulatory planning.

Speakers

Heather Peterson, RN, BSN, Pediatric Strategy Liaison, Director, Centre for Pediatric Clinical Development, Maternal Fetal Medicine Unit, ICON

Ms. Heather Peterson has a diverse background in clinical research, both as a registered nurse (RN) and in implementing clinical trials at the site and CRO level. She applies her expertise in pediatric populations to assist in strategic review of protocol development, ensuring critical pediatric content is thoughtfully measured and consistent with governing bodies while incorporating patient-family centric considerations. She previously served as the lead clinical research coordinator at Renown Regional Medical Center, a non-profit hospital in Reno, Nevada, where she coordinated and managed clinical trials of varied phases and indications. She worked across several therapeutic specialties to streamline scientific review committees and institutional review boards (IRB) submission processes. She brings a site and patient perspective that is valuable in developmental aspects of patient recruitment, enrollment and retention.

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Jo Dewhurst, Director, Centre for Pediatric Clinical Development, Drug Development Services, ICON

Jo Dewhurst has over 20 years of experience in the CRO industry, mainly in global regulatory affairs, including 15+ years’ experience supporting pediatric clinical trials in a broad range of indications, including rare diseases. Her current focus is on pediatric clinical development, supporting sponsors with all aspects of pediatric clinical development. Jo has a Bachelor of Science degree from the University of Glasgow and a Law degree from the University of Strathclyde.

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