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