Agenda

Day 1 Oct 30, 2023

1:00 PM — 4:30 PM

Tools and Methods to Evaluate the Effectiveness of Risk Minimization Measures

1:00 PM — 4:30 PM

Tools and Methods to Evaluate the Effectiveness of Risk Minimization Measures

Day 2 Nov 02, 2023

9:00 AM — 12:30 PM

Global Advertising and Promotion – Considerations for Compliance and Success

Day 3 Nov 07, 2023

7:30 AM — 6:00 PM

Meeting Registration

7:30 AM — 8:30 AM

Networking Breakfast

8:30 AM — 8:55 AM

Welcome and Opening Remarks

8:55 AM — 10:00 AM

Session 1 Plenary: The Future of Therapeutic Products Development: Current Emerging Trends and Technologies

10:00 AM — 10:40 AM

Refreshments, Exhibits, and Networking Break

10:40 AM — 12:10 PM

Session 2, Tracks A, B, C: Advancing Agile Regulations for Drugs: Updates from Health Canada

12:10 PM — 1:10 PM

Luncheon, Exhibits, and Networking Break

1:10 PM — 2:10 PM

Session 3, Tracks A, B, C: Integrating Equity, Diversity and Inclusion Across the Drug Product Lifecycle

2:10 PM — 2:50 PM

Refreshment and Networking Break

2:50 PM — 4:05 PM

Session 4, Track A: Innovation in Therapeutic Product and Device Development

2:50 PM — 4:05 PM

Session 4, Track B: Key Changes to the ICH E6 R3 Guidelines

2:50 PM — 4:05 PM

Session 4, Track C: Creating a Safer Framework for Medicines Use in Pregnant and Breastfeeding People

4:15 PM — 5:30 PM

Session 5, Track A: Accelerating Access to Medicines Through Collaboration

4:15 PM — 5:30 PM

Session 5, Track B: Optimizing Clinical Trials Operationally in Canada

4:15 PM — 5:30 PM

Session 5, Track C: Notification of Foreign Actions: Challenges and Best Practices

5:30 PM — 6:30 PM

Networking Reception

Day 4 Nov 08, 2023

7:30 AM — 4:00 PM

Meeting Registration

7:30 AM — 8:30 AM

Networking Breakfast

8:30 AM — 9:45 AM

Session 6, Track A: Nitrosamine Impurities – What’s New and Where Do We Stand?

8:30 AM — 9:45 AM

Session 6, Track B: Decentralized Clinical Trials

8:30 AM — 9:45 AM

Session 6, Track C: Good Pharmacovigilance Practices Inspection Readiness

9:45 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 11:45 AM

Session 7, Track A: Advancements in Regulatory Data Transformation

10:30 AM — 11:45 AM

Session 7, Track B: Clinical Trials: Focus on Patients, Innovation and Automation

10:30 AM — 11:45 AM

Session 7, Track C: Artificial Intelligence (AI) in Pharmacovigilance

11:45 AM — 12:45 PM

Luncheon, Exhibits, and Networking Break

12:45 PM — 2:00 PM

Session 8, Track A: Do You Have a Handle on Data Transparency? Best Practices for Management and Public Release of Clinical Data and Confidential Business Information

12:45 PM — 2:00 PM

Session 8, Track B: Clinical and Commercial Challenges of Emerging Therapies: Lessons Learned from Psychedelics and Cannabinoids

12:45 PM — 2:00 PM

Session 8, Track C: When Quantity Affects Quality: The Consequences of Overreporting

2:00 PM — 2:40 PM

Refreshments, Exhibits, and Networking Break

2:40 PM — 3:55 PM

Session 9 Plenary: How to Make Good Decisions Quickly

3:55 PM — 4:10 PM

Closing Remarks

4:10 PM — 4:10 PM

Meeting Adjourns

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