Drug Safety and Pharmacovigilance Across the Product Lifecycle

Agenda

Day 1 Oct 12, 2020

6:30 AM — 7:30 AM

Pre-Course Work: Part 1: Introduction to Drug Safety

7:30 AM — 8:30 AM

Pre-Course Work: Part 2: Drug Safety Regulatory Requirements

8:30 AM — 9:00 AM

Pre-Course Work: Part 3: Global Safety Regulatory Resources

9:00 AM — 12:00 PM

Part 1 – Clinical Trial Safety

12:45 PM — 4:45 PM

Part 2 – Clinical Trial Safety

Day 2 Oct 13, 2020

9:00 AM — 12:15 PM

Part 3 – Post-Marketing Safety

1:00 PM — 5:15 PM

Part 4 – Post-Marketing Safety and Case Reporting

Day 3 Oct 14, 2020

9:00 AM — 12:45 PM

Part 5 – Safety Operations and Safety Evaluation

1:30 PM — 4:30 PM

Part 6 – Safety Operations and Safety Evaluation

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