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Session 1 Plenary: Enhancing Regulatory Decisions using The Digital Advantage: AI Driven Insights for Seamless Information Sharing and Earlier Access
Session Chair(s)
Yatika Kohli, MBA
Chief Compliance and Strategy Officer, NoNO Inc, Canada
Stephanie Anderson, MS
Associate Director, Regulatory Affairs, Intrinsik Corp., Canada
This session explores how the integration of digital data and AI is transforming regulatory decision making and accelerating patient access. Speakers will highlight how advanced analytics, real time data exchange, and secure digital platforms are enabling more seamless information sharing across regulators, industry, and global partners. Through practical examples and forward looking insights, the session will demonstrate how AI driven intelligence can reduce inefficiencies, strengthen evidence generation, and support faster, more predictable regulatory pathways—ultimately delivering earlier access to high value therapies.
Learning Objective : At the conclusion of this session, participants should be able to: - Explain how AI and digital data enhance regulatory decisions
- Describe how interoperable systems enable secure, seamless data sharing
- Assess how digital integration streamlines workflows and accelerates patient access
Speaker(s)
Speaker
Sandra Krogulski, MA
Senior Director, Regulatory Digital Strategy and External Engagement, Bristol Myers Squibb, United States
Speaker
Tharany Ganesh
Head, Regulatory Affairs, AstraZeneca Canada Inc., Canada
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