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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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Component Type: Session



Speaker

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



Speakers
CM

Camille Metais

Senior Director Regulatory Affairs, Alexion Pharma GmbH
avatar for Pedro Borga

Pedro Borga

Consultant, Lifescience Dynamics Ltd


Wednesday February 6, 2019 10:15 - 10:45
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria