Workshop: Pediatric Drug Development

Regulatory and development experts will engage with participants at this special one day pediatric workshop to acknowledge the unique challenges of pediatric drug development with focus on hot topics for successful pediatric drug development. This workshop will highlight innovative perspectives from top pediatric thought leaders in areas of toxicology, formulation, pharmacokinetics/pharmacodynamics, biostatistics, extrapolation, safety, regulation and operations. In addition, Dr. Lynne Yao, Director of the Division of the Pediatric and Maternal Health at US Food and Drug Administration, will give a “future horizons” keynote talk. This pediatric-focused workshop is open to interested professionals, particularly the medical product developer, reviewer, clinician, scientist, trialist, investor or payer who seeks a survey of innovative pediatric drug development reaching beyond the boundaries of traditional pharmaceuticals. It would be especially valuable to those who plan careers in the field or who work in pediatric drug development.

Administrative details

Each year, in addition to its course, ACDRS also presents a workshop that is open to all interested parties.

• The workshop topic changes from year to year. (To be notified of new workshops, email [email protected] with your request.)
• It is scheduled so that it is convenient for current ACDRS participants to attend, but you don’t need to be enrolled in ACDRS to attend.

Previous workshop

Substantial Evidence in 21st Century Regulatory Science: Borrowing Strength from Accumulating Data

Questions?

Please contact [email protected].