FDA Clinical Data Summary Pilot Program

FDA Clinical Data Summary Pilot Program

What did the FDA put forward to enhance Transparency? Background   On 16. January 2018, FDA Commissioner, Scott Gottlieb announced the FDA’s intention to evaluate how they could share Clinical Documents of Pivotal Phase III studies following a successful...
PHUSE Utrecht SDE 2019

PHUSE Utrecht SDE 2019

Meet us at the PHUSE Utrecht SDE 2019 on 10 October   Jean-Marc Ferran will be presenting with Bjarke Klein (Ferring Pharmaceuticals) on implementing a Life Cycle Management process for programs in LSAF on Thursday, 10 October: Managing Program Development Life...