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Session 5, Track 4: Enhancing Regulatory Submissions and Interactive Communication: Insights from PRISM
Session Chair(s)
Dominik Gigli
Management Consultant & Regulatory Consulting Lead
Main5 GmbH & Co. KGaA, Germany
Dive into PRISM, a cutting-edge collaboration between the FDA and industry, leveraging FDA's cloud platform, PrecisionFDA. Explore real-world use cases that address today's regulatory challenges and pave the way for future advancements.
Vada Perkins, DrSc, Boehringer Ingelheim
Omar Serang, DNAnexus
Brooke Casselberry, Epista Life Sciences
Akira Yamaguchi, LORENZ Life Sciences Group
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize how cloud-based technologies can enhance data exchange and regulatory collaboration
- Develop an understanding of PRISM use cases and their potential to inform solutions for transforming regulatory submissions
Speaker(s)
PROJECT PRISM
Vada Perkins, MS
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
From COTS to Cloud
Akira Yamaguchi, MBA
LORENZ Life Science Group, United States
Chief Technical Officer
Ten Years of Evolution of a Regulatory Cloud
Omar Serang
DNAnexus, United States
Chief Cloud Officer
TRS Business Use Cases
Brooke Casselberry, MS, RAC
Epista Life Science, United States
Vice President, Advisory and Delivery
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