#None #Toronto #Xtalks #Pediatric Study Plans #Pediatric Investigation Plans

Strategies and Tools for Pediatric Protocol Development

On October 15, 2025, Xtalks will host a critical webinar aimed at addressing the complexities involved in pediatric protocol development. This free event will feature discussions about Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs), which play an essential role in establishing greater access to medical treatment for children. The webinar will provide valuable insights into effectively identifying and mitigating risks during pediatric clinical development.

Understanding the Challenges in Pediatric Protocol Development

Pediatric clinical trials are marked by unique challenges. Unlike adult studies, the enrollment of children often involves stricter regulatory requirements and ethical considerations. Moreover, there are inherent risks owing to the limited population size and differing physiological responses compared to adults. As a result, creating pediatric protocols requires a nuanced approach that balances compliance with regulatory frameworks and the ethical and medical needs of younger patients.

Key Strategies for Risk Management

The upcoming webinar will focus on multiple strategies designed to manage these complexities. One of the primary tools that will be discussed is the Pediatric Risk Assessment Map (PRAM). Developed by ICON's Centre for Pediatric Clinical Development (CPCD), this interactive tool aims to assist researchers in confirming, quantifying, and assessing risks at various stages of a pediatric-focused program. Participants will discover how to effectively utilize PRAM to enhance risk management, leading to better regulatory alignment and ultimately improved access to pediatric care.

Registration and Event Details

This event will feature two prominent speakers:

• - Heather Peterson, RN, BSN - Pediatric Strategy Liaison and Director at ICON’s Centre for Pediatric Clinical Development.
• - Jo Dewhurst - Director at ICON's Centre for Pediatric Clinical Development.

Both speakers bring a wealth of experience in pediatric clinical development and will share their expert knowledge on employing effective tools and strategies. Attendees will benefit from their insights on aligning pediatric protocols with adult treatment pathways, ensuring that both groups can receive adequate medical care without compromising safety and efficacy.

The webinar will take place on Wednesday, October 15, 2025, at 10 AM EDT (4 PM CEST). Registration is currently open, and those interested are encouraged to reserve their spot early to gain access to practical insights into pediatric protocol development and risk mitigation strategies.

Importance of PIPs and PSPs

PIPs and PSPs are crucial frameworks that facilitate the regulatory procedures necessary for conducting pediatric trials. They allow for the identification and integration of pediatric needs into the development of new treatments and ensure that children can access these innovations subsequently. These plans also serve as a roadmap for compliance with global regulatory bodies, allowing sponsors to manage their responsibilities effectively while navigating the complexities involved.

Conclusion

This webinar promises to be an invaluable resource for professionals involved in pediatric research, regulatory affairs, and clinical development. With the contributions from experienced practitioners in the field, attendees will leave equipped with the knowledge and tools necessary to enhance the effectiveness of pediatric protocol development in their work. Xtalks continues to be a leading platform for connecting industry experts and providing cutting-edge educational resources tailored to the evolving field of life sciences.

For more information about the event and to reserve your spot, visit the official Xtalks website. Don’t miss this opportunity to enhance your understanding and application of pediatric clinical protocols!

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