Re-Imagining Drug Development and Regulatory Submissions through Cloud-Based Technologies

1:45 PM - 2:45 PM (EDT), Wednesday, June 7, 2023 ・ Session Room 256
This session will review exciting developments in cloud-based submissions which are now a reality through next generation data exchange and global convergence. We will share practical learnings from companies with experience in feature and product previews using cloud-based technologies. Panelists will build on Accumulus Synergy’s experience to date, the regulatory policy considerations, and questions needed to navigate towards an aspirational future that will enable enriched and accelerated decision making on medicines benefiting patients globally.
Moderator
Chief Regulatory Innovation Officer
Accumulus Synergy
Speakers
Senior Director, Science and Regulatory Affairs
Johnson & Johnson
AZ Lead for Accumulus Synergy - Business Transformation, ORSSE
AstraZeneca
Executive Director and Lead, Global Regulatory and R&D Policy
Amgen
Head, Regulatory Science Policy North America
Sanofi
Head of US Regulatory Policy
GSK