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Session 2, Track A: Move from Reactive to Resilient - Canada’s Strategic Vision for Supply Chain Security and Global Harmonization
Session Chair(s)
Rebecca Humecky
Associate Director, Regulatory Affairs CMC, Cytokinetics Inc., United States
Oxana Iliach, PhD
Senior Director Regulatory Strategy, Certara, Canada
Drug shortages and supply chain disruptions have exposed critical vulnerabilities in how medicines are sourced, manufactured, and distributed worldwide, prompting Canada to rethink its approach from reactive crisis management to proactive resilience. This session brings together diverse perspectives to examine the root causes of supply chain fragility and the global harmonization efforts underway to strengthen quality standards and reduce shortage risk. Speakers will discuss practical strategies for risk mitigation, including diversified sourcing, early-warning systems, and cross-border regulatory cooperation, while highlighting Canada's role in shaping a more resilient and secure pharmaceutical supply chain. Attendees will gain actionable insight into how aligning Canadian policy with international standards can help prevent future shortages and protect patient access to essential medicines.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify key causes driving drug shortages and supply chain disruptions in the Canadian market
- Examine harmonization strategies and compendial standards that support proactive risk mitigation across supply chains
- Apply resilience-building frameworks to strengthen sourcing diversification and early-warning systems within drug development programs
Speaker(s)
Chaitanya Koduri, DDS, MHS
Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Onshoring in the Americas: Health Canada Perspectives on Building Resilient Medicine Supply Chains
Maria Amaya, MS
Lead External Advocacy, North America , Genentech, A Member of the Roche Group, United States
From Reactive to Proactive: The Role of Canada in Harmonizing Global Shortage Prevention Requirements
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