Agenda

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Day 1 Sep 25, 2024

7:30 AM — 8:15 AM

Networking Breakfast

7:30 AM — 6:30 PM

Registration

8:00 AM — 9:00 AM

Welcome and introduction to the workshop and its goals

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:45 AM

Session 1 Plenary: Regulatory System Strengthening: Updates on the Implementation of Good Regulatory Practices

9:45 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 12:00 PM

Session 2 Plenary: Latin America in Perspective: Projects and Priorities from Key Stakeholders in the Region

12:00 PM — 1:00 PM

Luncheon, Exhibits, and Networking Break

12:15 PM — 12:55 PM

Roundtable Discussions: Driving Progress: Reliance in Action for Latin America

1:00 PM — 2:30 PM

Session 3, Track A: Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence

1:00 PM — 2:30 PM

Session 3, Track B: Challenges, Practices, and Governance in Pharmacovigilance and Technovigilance: Harmonization Efforts in Safety

1:00 PM — 2:30 PM

Session 3, Track C: Communicating Science, End-to-end Messaging and Storytelling: Innovative ways to Present Data

2:30 PM — 3:15 PM

Refreshments, Exhibits, and Networking Break

3:15 PM — 4:30 PM

Session 4, Track A: Empowering Reliance: Tools and Insights for Enhanced Regulatory Practices

3:15 PM — 4:30 PM

Session 4, Track B: Pharmacovigilance Inspections in Latin America – Current Scenario, Expectations and Trends

3:15 PM — 4:30 PM

Session 4, Track C: Customer Engagement and Insights

4:35 PM — 5:50 PM

Session 5, Track A: Management of Product Lifecycle: Challenges and Suggested Solutions

4:35 PM — 5:50 PM

Session 5, Track B: New Era for Signal Detection

4:35 PM — 5:50 PM

Session 5, Track C: Innovation in Artificial Intelligence (AI) and Technology for MASC

5:50 PM — 6:50 PM

Networking Reception

Day 2 Sep 26, 2024

7:30 AM — 8:15 AM

Networking Breakfast

7:30 AM — 4:00 PM

Registration

8:15 AM — 9:30 AM

Session 6 Plenary: Advancements in Patient Safety and Centricity in the Pharmaceutical Industry: Empowering and Engaging Better Healthcare

9:30 AM — 10:15 AM

Refreshments, Exhibits, and Networking Break

10:15 AM — 11:30 AM

Session 7, Track A: The Future of Regulatory Submissions: CTD, eCTD, and Cloud-based Systems

10:15 AM — 11:30 AM

Session 7, Track B: Risk Management and Communication as a Cornerstone of Safety Strategy

10:15 AM — 11:30 AM

Session 7, Track C: Areas of Focus and Skills: Training, Medical Information as a Strategic Partner and Internal Communication

11:30 AM — 12:30 PM

Luncheon, Exhibits, and Networking Break

11:45 AM — 12:25 PM

Roundtable Discussions: Driving Progress: Reliance in Action for Latin America

12:30 PM — 1:45 PM

Session 8, Track A: Outsourcing Clinical Operations, Hybrid Model Approach in Clinical Trial Execution

12:30 PM — 1:45 PM

Session 8, Track A: Regulation of Medicinal Products for Rare Disease: Challenges and Opportunities

12:30 PM — 1:45 PM

Session 8, Track B: Technological Advancements and Data Utilization Opportunities in Pharmacovigilance

1:45 PM — 2:30 PM

Refreshments, Exhibits, and Networking Break

2:30 PM — 3:45 PM

Session 9 Plenary: Fostering Regional Initiatives to Enhance Regulatory Capacity and Strengthen Health Systems

3:45 PM — 4:00 PM

Closing Remarks

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Latin America Annual Meeting

Agenda

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