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Session 8, Track A: Unlocking Global Convergence: Enabling Harmonization and Reliance for Faster Access
Session Chair(s)
Yatika Kohli, MBA
Chief Compliance and Strategy Officer, NoNO Inc, Canada
Amy Chan
Associate Director, Regulatory Affairs, Takeda Canada Inc., Canada
This session explores how global convergence, harmonization, and reliance can meaningfully reduce regulatory burden and accelerate access to innovative therapies. Health Canada will provide an update on the proposed Reliance Order published in Canada Gazette, Part I, outlining how the framework is intended to strengthen regulatory agility, support international alignment, and enable more efficient decision making. Complementing this, industry speakers will share practical insights on implementing global reliance strategies, including opportunities and challenges in operationalizing convergence across regions. The session will conclude with a focused case study on streamlining regulatory workload for post approval changes through harmonization, international collaboration, and reliance mechanisms. Attendees will gain a clear understanding of how regulators and industry can jointly advance a more predictable, efficient, and globally connected regulatory ecosystem.
Learning Objective : At the conclusion of this session, participants should be able to: - Recognize HC’s proposed Reliance Order and its implications for regulatory agility, international alignment, and decision making efficiency.
- Evaluate industry perspectives on implementing global reliance, including operational challenges and enablers.
- Apply harmonization and reliance principles to streamline post approval change management and reduce regulatory workload.
Speaker(s)
Jennifer Wilhelm, MBA, MS, RAC
Dir, Regulatory Affairs, Merck & Co., Inc., Canada
Streamlining Regulatory Workload for Post-Approval Changes Through Harmonization, International Collaboration and Reliance
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