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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 11 Track 3: Exploring Opportunities and Challenges of Cloud Technology for Industry and Regulators

Session Chair(s)

Sandra  Krogulski, MA

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
  • Identify current challenges and potential solutions in implementing cloud-based technologies for regulatory use


Rebecca  Nebel, PhD

Past, Present, and Future: Utilizing Cloud Technology for Regulatory Use

Rebecca Nebel, PhD

PhRMA, United States

Senior Director, Science and Regulatory Advocacy

Helen Yejin Saccone, PharmD

FDA’s Approach to Leveraging Cloud Technology

Helen Yejin Saccone, PharmD

FDA, United States

Associate Director, Global Regulatory Policy, GO, OC

Vada A. Perkins, DrSc, MSc

Security, Privacy, Quality, and Compliance Requirements for a Cloud-based Regulatory Platform

Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

Hilmar  Hamann, PhD

Exploring Cloud Technology: The Future of Regulatory Submission & Collaboration

Hilmar Hamann, PhD

European Medicines Agency, Netherlands

Head of Information Management

Ginny  Hussong

An Introduction to PRISM (precisionFDA Regulatory Information Service Module)

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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