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Wednesday
, February 6 • 10:15 - 10:45
#PS04: Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub
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An overview of the current status and trends in the Breakthrough Designation, PRIME and SAKIGAKE expedited review programs
Pedro Borga, MPharm
Early Actions granted by FDA: a review of the frequency and importance of NDA/BLA approvals in advance of DUFA action date
Camille Metais, MSc
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Camille Metais
Senior Director Regulatory Affairs, Alexion Pharma GmbH
Pedro Borga
Consultant, Lifescience Dynamics Ltd
Wednesday February 6, 2019 10:15 - 10:45 CET
Content Hub 4
Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
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