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Evaluation ViewAttendees 11

Biopharmaceuticals (includes Biologics and Drugs)

Conversation Starters

Pediatric Drug Development: Failure is not an Option

Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT
Location/Room: 513B
Intermediate Level
Description: Product development in pediatrics is challenging, however bringing a product to market that addresses safety and efficacy in pediatrics is tremendously rewarding. Creation and coordination of the regulatory pathway which results in an approved product that addresses pediatric needs is grounded on engagement with the regulators early and often. This interactive session will actively engage the audience through scenario planning to highlight strategic imperatives, pitfalls, and insights into the FDA and EU policies, regulations and guidances.

*One lucky attendee will win a copy of RAPS Global Pediatric Development of Drugs, Biologics, and Medical Devices book.

Learning Objectives:

  • Explore the latest updates to US and EU requirements
  • Mitigate the regulatory risks (ie. divergent EMA and FDA recommendations)
  • Exploit the benefits (ie. rare pediatric designation, priority review)