Agenda

Day 1 Jan 26, 2025

9:00 AM — 4:00 PM

Short Course: Aggregate Safety Assessment Planning (ASAP) Process

1:00 PM — 4:00 PM

Short Course: Introduction to Statistics in Drug Safety

Day 2 Jan 27, 2025

7:30 AM — 5:00 PM

Conference Registration

7:30 AM — 8:30 AM

Networking Breakfast

8:30 AM — 8:45 AM

Welcome and Opening Remarks

8:45 AM — 9:30 AM

Session 1: Keynote Address

9:30 AM — 10:15 AM

Networking Break in Exhibit Hall

9:35 AM — 10:05 AM

Hosted Session/Non-CE: Case Study Hosted by RxLogix

10:15 AM — 11:30 AM

Session 2: Regulatory Updates on Polices and New Guidances from Other Territories and International Harmonization

11:30 AM — 12:30 PM

Networking Luncheon in the Exhibit Hall

12:30 PM — 1:45 PM

Session 3: Updates on Polices, Guidances and Regulations – United States (U.S. Food and Drug Administration (USFDA)

1:50 PM — 3:05 PM

Session 4: Europe and United Kingdom: Regulatory Updates on Policies and Guidances

3:05 PM — 3:45 PM

Networking Break in the Exhibit Hall

3:10 PM — 3:40 PM

Hosted Session/Non-CE: Case Study Hosted by APCER

3:45 PM — 5:00 PM

Session 5: Real-World Evidence in Action: Bridging Data for Regulatory Decisions and Drug Safety

5:00 PM — 6:00 PM

Networking Reception

Day 3 Jan 28, 2025

7:30 AM — 5:00 PM

Conference Registration

7:30 AM — 8:00 AM

Networking Breakfast

8:00 AM — 10:30 AM

Session 6 and 7 : Global Convergence in Risk Management Guidance Driving New Innovation Opportunities

10:30 AM — 11:15 AM

Networking Break in the Exhibit Hall

10:35 AM — 11:05 AM

Hosted Session/Non-CE: Case Study Hosted by IQVIA

11:15 AM — 12:30 PM

Session 8: Harnessing AI in Pharmacovigilance: Insights, Applications, and Impact

12:30 PM — 1:30 PM

Networking Luncheon and Roundtable Discussions in the Exhibit Hall

1:30 PM — 3:00 PM

Session 9: Advancing Hepatic Safety: Innovations in Predicting, Assessing, and Managing Drug-Induced Liver Toxicity

3:00 PM — 3:30 PM

Networking Break in the Exhibit Hall

3:30 PM — 5:00 PM

Session 10: Enhancing Drug Development with Early Benefit-Risk Strategies and Decision-Driven Visualizations

Day 4 Jan 29, 2025

7:30 AM — 12:45 PM

Conference Registration

7:30 AM — 8:00 AM

Networking Breakfast

8:00 AM — 9:15 AM

Session 11: Navigating Pharmacovigilance in Small Pharma: Strategies for Building Sustainable Frameworks

9:20 AM — 10:35 AM

Session 12: Mastering FDA’s New Draft Guidance: Optimizing Data Monitoring Committees in Clinical Trials

10:35 AM — 11:15 AM

Networking Break in the Exhibit Hall

10:40 AM — 11:10 AM

Hosted Session/Non-CE: Case Study Hosted by Truveta

11:15 AM — 12:30 PM

Session 13: Innovations in Safety Signal Detection and Causality Assessment: From Knowledge Graphs to Best Practices

12:30 PM — 12:45 PM

Closing Remarks

12:45 PM — 12:45 PM

Conference Adjourns

Have an account?

Global Pharmacovigilance and Risk Management Strategies Conference

Agenda

Be informed and stay engaged.