Agenda

Day 1 Feb 21, 2019

7:30 AM — 8:15 AM

Continental Breakfast and Networking

7:30 AM — 5:30 PM

Registration

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:45 AM

Session 1: Regional and Global Regulatory Priority Updates

9:45 AM — 10:15 AM

Refreshment and Networking Break

10:15 AM — 11:30 AM

Session 2: Progress in Regulatory Harmonization and Convergence

11:30 AM — 12:30 PM

Luncheon and Networking

12:30 PM — 2:30 PM

Session 3: Update on IMDRF and MDSAP and Their Relevance to the Latin America Region

2:30 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 4:30 PM

Session 4: Regulatory Cooperation and Reliance Session

4:30 PM — 5:30 PM

Session 5:Regulatory Update in Approving Biosimilars and Approach to Interchangeability

5:30 PM — 6:30 PM

Networking Reception

Day 2 Feb 22, 2019

7:15 AM — 8:15 AM

Continental Breakfast and Networking

7:30 AM — 5:00 PM

Registration

8:15 AM — 8:30 AM

Welcome to Day Two

8:30 AM — 10:00 AM

Session 6: New Trends in Regulatory Science

10:00 AM — 10:30 AM

Refreshment and Networking Break

10:30 AM — 12:30 PM

Session 7: Lifecycle Management– How to Cope with the Increasing Regulatory Demand on Post-Approval Changes for Faster Medicines Access to Patients?

12:30 PM — 1:30 PM

Luncheon and Networking

1:30 PM — 2:30 PM

Session 8: CTD for Registration Purposes in LATAM

2:30 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 5:00 PM

Session 9: Clinical Trials Adaptative Designs Protocols: Ethics and Regulatory Perspectives

5:00 PM — 5:15 PM

Closing Remarks

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Latin America Regulatory Conference

Agenda

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