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Session 11 Track 3: Exploring Opportunities and Challenges of Cloud Technology for Industry and Regulators
Session Chair(s)
Sandra Krogulski, MA
Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States
Although cloud technology is not a new concept, it has recently gained significant attention in our industry due to the opportunities and efficiencies it offers. This session aims to provide an overview of the regulatory landscape of cloud-based technologies, highlighting the opportunities and challenges associated with implementing them for regulatory use. With examples, case studies, discussion and input from the FDA and EMA regulators, the panel will explore the practicalities of cloud technology and discuss how further advancements could enhance the submission landscape.
Learning Objective : At the conclusion of this session, participants should be able to:- Illustrate how cloud-based technologies can enhance data exchange and regulatory review
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Identify current challenges and potential solutions in implementing cloud-based technologies for regulatory use
Speaker(s)
Past, Present, and Future: Utilizing Cloud Technology for Regulatory Use
Rebecca Nebel, PhD
PhRMA, United States
Senior Director, Science and Regulatory Advocacy
FDA’s Approach to Leveraging Cloud Technology
Helen Yejin Saccone, PharmD
FDA, United States
Associate Director, Global Regulatory Policy, GO, OC
Security, Privacy, Quality, and Compliance Requirements for a Cloud-based Regulatory Platform
Vada Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Exploring Cloud Technology: The Future of Regulatory Submission & Collaboration
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Head of Information Management
An Introduction to PRISM (precisionFDA Regulatory Information Service Module)
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
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