Agenda

Day 1 Feb 24, 2020

7:00 AM — 5:00 PM

Registration

7:15 AM — 8:15 AM

Continental Breakfast and Networking

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 10:30 AM

Session 1: Regional and Global Regulatory Priority Updates

10:30 AM — 11:00 AM

Refreshment and Networking Break

11:00 AM — 11:30 AM

Regulators Q&A Panel

11:30 AM — 1:00 PM

Session 2: Reliance and Regulatory Systems Strengthening

1:00 PM — 2:00 PM

Luncheon and Networking

2:00 PM — 3:30 PM

Session 3: Lifecycle Management – Walking Towards Harmonized and Efficient Procedures to Manage Post-Approval Changes in Benefit of Patients

3:30 PM — 4:00 PM

Refreshment and Networking Break

4:00 PM — 5:30 PM

Session 4: Continuous Manufacturing and ICH Q13

5:30 PM — 6:30 PM

Networking Reception

Day 2 Feb 25, 2020

7:00 AM — 8:00 AM

Continental Breakfast and Networking

7:00 AM — 5:00 PM

Registration

8:00 AM — 9:30 AM

Session 5: Advanced Therapies and Gene Editing

9:30 AM — 10:00 AM

Refreshment and Networking Break

10:00 AM — 12:00 PM

Session 6: Initiatives of Regulatory Convergence

12:00 PM — 1:00 PM

Luncheon and Networking

1:00 PM — 2:30 PM

Session 7: Real Word Evidence: How Can it be Used to Support Regulatory Decision-Making

2:30 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 4:30 PM

Session 8: Patient Centricity from a Concept to Reality

4:30 PM — 5:30 PM

Session 9: Medical Devices Regulatory Frameworks on the Move

5:30 PM — 5:45 PM

Closing Remarks: Summary of Takeaways and Calls to Action

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Latin America Regulatory Conference

Agenda

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