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ViewAttendees 4

Pharmaceuticals

Domain: Product Development & Registration

Knowledge Area: Regulatory Guidance

Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?

Friday, May 12, 2023
14:00 – 15:00 CEST
Location: Pearl 1

Supported By
Description: Pregnant and breastfeeding individuals are consistently excluded from clinical development due to complex challenges (e.g., scientific, regulatory, ethical or legal challenges). Women require access to drugs during pregnancy and lactation and deserve to have timely information about the safe and efficacious use of medicines during these time periods. Current regulatory environment for generating data in this population is requiring post-approval activities which lead to delays in data availability and, thus, a paradigm shift to achieve earlier evidence generation is needed.
Similarly neonates or children with rare diseases would benefit of more attention knowing the scientific progress made in drug development. Despite increased drug development efforts, there is also still a lack of available medicines in the pediatric patient population, who would benefit of the scientific progress made.


Learning Objectives:

  • Understand the value to assess the needs for early development in these specific patient populations
  • Understand current regulatory trends and how such a development could look like
  • Understand the challenges of product development in such special populations
  • Understand some of the solutions to address these challenges