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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Utilizing Cloud-Based Platforms in Regulatory Contexts

Session Chair(s)

Andrew  Robertson, LLM, PMP

Andrew Robertson, LLM, PMP

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)

Mary Ann  Slack

The Potential of Cloud Technology: A Regulatory Perspective

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Mark  Bach, MD, PhD

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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