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Transatlantic Collaboration on Pediatric Study Plan/Pediatric Investigation Plan: Recent Experience
Session Chair(s)
Vibeke Bjerregaard, MS
Senior Regulatory Policy Manager
Novo Nordisk A/S, Denmark
This session will discuss the US Pediatric Study Plan (PSP) and the EU Pediatric Investigation Plan (PIP), the timing of submissions, and the significant differences that still remain in the specific requirements from the two regulatory agencies.
Attendees are welcome to submit questions of interest to the speakers by emailing annualmeetingprogram@diaglobal.org; subject line: PSP/PIP Q/A
Learning Objective : Identify the differences in requirements from EMA versus FDA for the pediatric plans; Discuss the obstacles that these different requirements may cause to industry striving to get the pediatric investigation plan/pediatric study plan approved by both regions; Describe what would be needed to reduce these differences in requirements.
Speaker(s)
Advancing Pediatric Product Development Through International Collaboration
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Global Pediatric Development: Current and Future Initiatives for Increased Convergence Between Regions - FDA Perspective
Mary Dianne Murphy, MD
FDA, United States
Director, Office of Pediatric Therapeutics, Office of Special Medical Programs
Global Pediatric Development: Current and Future Initiatives for Increased Convergence Between Regions - EMA Perspective
Kristina Larsson, MS
European Medicines Agency, Netherlands
Head of Orphan Medicines, Division for Human Medicines Evidence Generation