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Towards Instantaneous Regulatory Decisions and Better Predictability
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, 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
Representative Invited
FDA, United States
Panelist
Tony Fantana, PhD
Eli Lilly, United States
Sr. Dir
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