Pediatric Drug Development MasterClass - US edition

We will navigate the intricacies of trial design, ethical conduct, regulatory frameworks, and the pursuit of evidence-based medicines tailored to the needs of pediatric populations, which includes neonates, adolescents, young adults, and pregnant women.

13-14 March, 2024, Virtual

Time Zone : Eastern Daylight Time (EDT) - UTC−04:00

Overview

Physicians often find themselves facing a challenging dilemma: how to provide the best possible care for their youngest patients when the toolbox of approved medicines for children remains frustratingly sparse. The issue of off-label drug use in pediatrics looms large, with over 40% and up to 90% of drugs in some healthcare settings prescribed without the assurance of specific pediatric approvals. In an effort to transform this landscape, significant strides have been taken, such as in the United States through legislative acts like the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the RACE for Children Act. These initiatives have pushed the boundaries of pediatric clinical research, but the path forward remains challenging. This course is designed to provide a comprehensive understanding of the medical, legal, operational, and participant elements at the heart of pediatric clinical research. Join us where you’ll gain insights into the complexities of pediatric clinical trials and the vital role they play. Together, we’ll navigate the intricacies of trial design, ethical conduct, regulatory frameworks, and the pursuit of evidence-based medicines tailored to the needs of pediatric populations, which includes neonates, adolescents, young adults, and pregnant women.

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RECOMMENDATION

Who should attend?

• Clinical development professionals
• Project Delivery & Management
• Scientific & Medical Affairs
• Clinical Trial Site personnel
• Patient Engagement
• Parent and Patient Advocates
• Regulatory Affairs
• IRB members
• Academics and Researchers
• Healthcare professionals