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SESSION 3: COLLABORATION BETWEEN EMA AND FDA
Session Chair(s)
Mette Due Theilade Thomsen, PhD
CEO
PIP Adviser, Denmark
Collaboration between EMA and FDA
Speaker(s)
How is Convergence on Timing between EU-US Possible?
Irmgard Eichler, DrMed
European Medicines Agency, Netherlands
Senior Scientific Officer Paediatric Medicines
Advancing Pediatric Product Development Through International Collaboration
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Discussion between EMA and FDA on PIP and Rare Diseases
Jean Temeck, MD
FDA, United States
Lead Medical Officer, Office of Pediatric Therapeutics, OC
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