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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)
Irmgard Eichler, DrMed
Senior Scientific Officer Paediatric Medicines, European Medicines Agency, Netherlands
How is Convergence on Timing between EU-US Possible?
Christina Bucci-Rechtweg, MD
Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Advancing Pediatric Product Development Through International Collaboration
Jean Temeck, MD
Lead Medical Officer, Office of Pediatric Therapeutics, OC, FDA, United States
Discussion between EMA and FDA on PIP and Rare Diseases
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