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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, 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)
Rebecca Nebel, PHD
Director, Global Regulatory Policy and Intelligence, Amgen, United States
Past, Present, and Future: Utilizing Cloud Technology for Regulatory Use
Helen Chung, PHARMD
Senior Advisor, Office of Global Policy and Strategy (OGPS), FDA, United States
FDA’s Approach to Leveraging Cloud Technology
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Security, Privacy, Quality, and Compliance Requirements for a Cloud-based Regulatory Platform
Hilmar Hamann, PHD
Chief Information Officer, European Medicines Agency, Netherlands
Exploring Cloud Technology: The Future of Regulatory Submission & Collaboration
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
An Introduction to PRISM (precisionFDA Regulatory Information Service Module)