Overview:
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.
What you’ll learn:
- How PIPs and PSPs support pediatric access and regulatory alignment
- Practical use of PRAM for early and ongoing risk identification
- Strategies to manage protocol risks in pediatric clinical development
- How to apply tools and resources across different stages of pediatric programs
Register now to reserve your spot and gain practical insights into risk mitigation and regulatory planning.
Who should attend:
This webinar is aimed at professionals with an interest in pediatric research including those working in the following areas:
- Research and development
- Clinical research
- Medical affairs
- Scientific affairs
- Regulatory affairs
- Clinical affairs
- Project management
- Clinical operations
- Risk management
- Executives
- Health care professionals
- Patient advocacy groups and their members
- Anyone with an interest in the future of pediatric research
Speakers:
Heather Peterson, RN, BSN
Ms Peterson has a diverse background in clinical research, both as a registered nurse (RN) and in clinical operations. 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.
Jo Dewhurst
Jo 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.