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Tuesday, June 16 • 2:00pm - 3:00pm
#238 SL: Utilizing Cloud-Based Platforms in Regulatory Contexts

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-584-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Recognize applications of cloud-platforms in regulatory processes; Identify principles and steps towards effective use of cloud systems.

Chair

Andrew Robertson, JD, PhD

Speaker

FDA Update
Mary Ann Slack

Industry Update
Mark Bach, MD, PhD


Speakers
avatar for Andrew Robertson

Andrew Robertson

Global Head of Strategy, and Business Transformation, Digital and Data Sciences, Sanofi
Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session