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Utilizing Cloud-Based Platforms in Regulatory Contexts
Session Chair(s)
Andrew Robertson, JD, PhD
Vice President, Head of Global Regulatory Policy and Innovation
Takeda, United States
This session will review the vision for transitioning to a cloud-based platform for regulatory submissions, include examples of using cloud-based platforms in drug regulation, explore additional focused use-cases, and frame questions to help solicit input from industries that have also successfully applied or benefited from cloud platforms. Importantly, these learnings should be in the context of designing an end-to-end cloud-based information network that would facilitate data exchange, analysis, and drug review on a global-scale.
Learning Objective : Recognize applications of cloud-platforms in regulatory processes; Identify principles and steps towards effective use of cloud systems.
Speaker(s)
The Potential of Cloud Technology: A Regulatory Perspective
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Accumulus: Designing and Implementing a Cloud-Based PPlatform for Sponsor/Health Authority Data Exchange
Mark Bach, MD, PhD
Johnson & Johnson, United States
Vice President, Office of the Chief Medical Officer
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