Agenda

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Day 1 Oct 26, 2026

7:30 AM — 8:30 AM

Networking Breakfast

7:30 AM — 6:30 PM

Registration

8:30 AM — 8:45 AM

Welcome and Opening Remarks

8:45 AM — 10:00 AM

Session 1 Plenary: The Digital Advantage: AI Driven Insights for Seamless Information Sharing, Regulatory Decision-Making and Earlier Access

10:00 AM — 10:45 AM

Refreshments, Exhibits, and Networking Break

10:45 AM — 12:00 PM

Session 2, Track A: Move from Reactive to Resilient - Canada’s Strategic Vision for Supply Chain Security and Global Harmonization

10:45 AM — 12:00 PM

Session 2, Track B: What’s New in Clinical Trial Regulation

10:45 AM — 12:00 PM

Session 2, Track C: Transform PV Workflows: Driving Innovation with AI and Automation to Solve Increasing Demandn

12:00 PM — 1:00 PM

Luncheon, Exhibits, and Networking Break

1:00 PM — 2:15 PM

Session 3, Track A: Reducing Burden, Accelerating Access - How Health Canada Is Streamlining Regulatory Work

1:00 PM — 2:15 PM

Session 3, Track B: Manage Trial Evolution: Aligning Patient-Centric DCTs and Digital Governance in Canada

1:00 PM — 2:15 PM

Session 3, Track C: Trust but Verify - Building and Governing High-Performing PV Partnerships

2:15 PM — 3:00 PM

Refreshments, Exhibits, and Networking Break

3:00 PM — 4:15 PM

Session 4, Track A: Accelerate Precision Medicine with Model-Informed Drug Development: From Insight to Regulatory Impact

3:00 PM — 4:15 PM

Session 4, Track B: From Participation to Partnership: Advancing Patient Engagement in Clinical Development

3:00 PM — 4:15 PM

Session 4, Track C: Translate Policy into Practice: Applying Health Canada's 2026 Pharmacovigilance Guidance

4:25 PM — 5:40 PM

Session 5, Track A: Transform Canadian Regulatory Decision-Making - Real-World Data Integration and the Future of Patient-Centered Market Access

4:25 PM — 5:40 PM

Session 5, Track B: Advancing Pediatric Drug Development: Innovations and Challenges in Clinical Research

4:25 PM — 5:40 PM

Session 5, Track C: Navigate Health Canada GVP Guidance updates - Achieve Inspection Readiness and Strengthen PV Compliance in Canada

5:40 PM — 6:40 PM

Networking Reception

Day 2 Oct 27, 2026

7:30 AM — 8:30 AM

Networking Breakfast

7:30 AM — 4:30 PM

Registration

8:30 AM — 9:45 AM

Session 6, Track A: Navigating AI Capabilities for a Safe Evolution of Regulatory Workflows used to Manage Regulatory Content and Submissions

8:30 AM — 9:45 AM

Session 6, Track B: Advancing Clinical Development with AI - Trends, Applications, and Lessons from the Field

8:30 AM — 9:45 AM

Session 6, Track C: Streamline Global Promotions: Adapt Materials and Activities for the Canadian Market

9:45 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 11:45 AM

Session 7, Track A: Optimizing Canadian Submissions: Risk-Based Framework Approach for Package Inserts, XML PM Authoring and CMC Trends

10:30 AM — 11:45 AM

Session 7, Track B: Translating ICH E6(R3) into Action - Perspectives from Regulators, Sponsors, and Operational Teams

10:30 AM — 11:45 AM

Session 7, Track C: From Signal to Action -Managing Safety Risks in Self-Care Products Without Perfect Data

11:45 AM — 12:45 PM

Luncheon, Exhibits, and Networking Break

12:45 PM — 2:00 PM

Session 8, Track A: Unlocking Global Convergence: Enabling Harmonization and Reliance for Faster Access

12:45 PM — 2:00 PM

Session 8, Track B: Focusing on What Matters Most: Operationalizing Critical-to-Quality Factors in Clinical Research

12:45 PM — 2:00 PM

Session 8, Track C: Apply Real-World Evidence in Canada - Design, Regulatory Expectations, and Safety Applications

2:10 PM — 3:25 PM

Session 9 Plenary: Canada Town Hall

3:25 PM — 3:40 PM

Closing Remarks

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