Agenda

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Day 1 Jan 25, 2023

10:00 AM — 2:00 PM

Short Course: Aggregate Safety Assessment Planning

Day 2 Feb 01, 2023

10:00 AM — 2:00 PM

Short Course: Good Pharmacovigilance Practice (GVP) Operations Development - From Clinical Trial to Post Marketing

Day 3 Feb 05, 2023

9:00 AM — 5:00 PM

Short Course: Pharmacovigilance and Risk Management Planning

Day 4 Feb 06, 2023

7:00 AM — 5:35 PM

Conference Registration

7:00 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

8:00 AM — 8:15 AM

Welcome and Opening Remarks

8:15 AM — 9:00 AM

Keynote Address: Research Integrity in the Quest for Therapies for Alzheimer’s Disease

9:05 AM — 10:20 AM

Session 1: Global Safety Regulatory Updates: Japan and China Regions

10:20 AM — 10:50 AM

Exhibitor Sponsored Session/Non-CE: Case Study hosted by PharSafer

10:20 AM — 10:50 AM

Refreshment, Exhibits, and Networking Break Sponsored by Eversana

10:50 AM — 11:50 AM

Session 2: Europe and United Kingdom Safety Regulatory Updates

11:50 AM — 1:00 PM

Luncheon, Exhibits, and Networking Break

12:00 PM — 1:00 PM

Sponsored Lunch and Learn Hosted by IQVIA: Transform your Local Safety and PV Processes by Harnessing AI, ML, and NLP Technologies (Invite Only)

1:00 PM — 2:30 PM

Session 3: FDA Safety Regulatory Updates

2:30 PM — 3:15 PM

Refreshment, Exhibits, and Networking Break Sponsored by Eversana

2:45 PM — 3:15 PM

Exhibitor Sponsored Session/Non-CE: Case Study hosted by Veeva Systems, Inc.

3:15 PM — 4:15 PM

Session 4: FDA Technical Specification for Implementing E2B R3

4:20 PM — 5:35 PM

Session 5: Divergences, Harmonization, and Patient Perspective in Risk Minimization

5:35 PM — 6:35 PM

Networking Reception and Exhibits

Day 5 Feb 07, 2023

7:00 AM — 4:35 PM

Conference Registration

7:00 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

8:00 AM — 8:25 AM

Welcome to Day 2 and DIA PV Community Update

8:30 AM — 9:45 AM

Session 6: Signal Detection

9:50 AM — 10:50 AM

Session 7: Optimizing Literature Surveillance: A Critical Element in the Pharmacovigilance Arsenal

10:50 AM — 11:20 AM

Exhibitor Event/Non-CE: Case Study hosted by IQVIA

10:50 AM — 11:20 AM

Refreshment, Exhibits, and Networking Break

11:20 AM — 12:35 PM

Session 8: Artificial Intelligence and Machine Learning Use in Patient Safety

12:35 PM — 1:35 PM

Luncheon, Exhibits and Networking Break

1:35 PM — 2:50 PM

Session 9: Real-World Evidence Support of Clinical Development Programs

2:50 PM — 3:20 PM

Refreshment, Exhibits, and Networking Break

3:20 PM — 4:35 PM

Session 10: Epidemiology in Post-Approval

Day 6 Feb 08, 2023

7:00 AM — 12:00 PM

Conference Registration

7:00 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

8:00 AM — 9:30 AM

Session 11: Pregnancy and Lactation: How Are we Going to Get Useful Data?

9:30 AM — 11:00 AM

Round Table Discussion Covering Special Topics and Considerations: Can We Have an Inclusive Approach to Clinical Trials and Pharmacovigilance?

11:00 AM — 11:30 AM

Refreshment, Exhibits, and Networking Break

11:30 AM — 12:45 PM

Panel Discussion: Safety Practices in Small Pharmaceutical Company Settings

12:45 PM — 12:55 PM

Closing Remarks

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Global Pharmacovigilance and Risk Management Strategies Conference

Agenda

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