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Session 7, Track A: Advancements in Regulatory Data Transformation
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Tharany Ganesh
Head, Regulatory Affairs
AstraZeneca Canada Inc., Canada
Ashley Jones-Mitchell
Director of Regulatory Innovation Strategy & Policy
Accumulus Synergy, United States
With the ultimate goal of supporting faster access of therapies to patients globally, panel participants in this session will share their perspectives on considerations around global collaboration and reliance regarding digital advancements. Industry and Health Canada representatives will share their thoughts on current challenges and successes when it comes to collaborative approaches and technological solutions. Accumulus Synergywill present two use cases on how the cloud-based technology was used to enable real time transformative information and data exchange between sponsors and health authorities.
Learning Objective : - Describe how a fit for purpose and highly secure platform can improve global collaboration
- Understand how a cloud-based data exchange can allow for governed flow of standardized information between life sciences organizations, health authorities and manufacturing sites
- Identify the opportunities for using cloud-based techology to streamline data exchange, analysis and interpretability
Speaker(s)
Improving Joint Review Processes and Outcomes - Access Consortium Case Study
Marcin Boruk, MBA, MSc
Health Canada, Canada
Manager RMOD, HFPB
An Accumulus Case Study: Enabling Transformative Data Exchange
Ashley Jones-Mitchell
Accumulus Synergy, United States
Director of Regulatory Innovation Strategy & Policy
Regulatory Reliance: A CMC Post-approval Change Pilot
Cynthia Ban
Sanofi, Canada
Global Head, Regulatory Affairs CMC, Vaccines