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Towards Instantaneous Regulatory Decisions and Better Predictability
Session Chair(s)
Dominique Lagrave, PHARMD
Chief Regulatory Officer
Accumulus Technologies, United States
An interactive sesion to reimagine regulatory frameworks and streamline product approvals globally. This session will focus on focus on data transparency, collaboration, process optimization and technology to accelerate medicine development and patient access.
Learning Objective : Recognize the power of data to accelerate submissions; Initiate pilot projects aiming at sharing data, not documents, and lay the groundwork for dynamic reviews; Create better pre-competitive collaborations to share more safety data and endpoints.
Speaker(s)
Panelist
Debra Yeskey
CEPI, United States
Head of Regulatory Policy and Intelligence
Panelist
Len Rosenberg, PHD, RPH
Beat AML, A Division of Blood Cancer United, United States
Head of Clinical Operations
Panelist
Tony Fantana, PHD
Eli Lilly and Company, United States
Senior Director
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