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Sheraton Philadelphia University City

Nov 09, 2015 8:30 AM - Nov 10, 2015 4:15 PM

3549 Chestnut Street, Philadelphia, PA 19104

Postmarketing Drug Safety and Pharmacovigilance

Agenda

8:30 AM8:45 AM

Introduction and Welcome

8:45 AM9:20 AM

Session 1: Background

9:20 AM10:00 AM

Session 2: Global Consensus

10:30 AM11:15 AM

Session 3: Requirements

11:15 AM12:00 PM

Session 4: New EU Requirements

1:00 PM1:45 PM

Session 5: Practicalities

1:45 PM2:15 PM

Session 6: Operational Aspects

2:15 PM2:45 PM

Session 7: Data

3:15 PM4:00 PM

Session 8: Aggregate Data

4:00 PM4:45 PM

Session 9: Special Situations

4:45 PM5:00 PM

Questions and Discussion

8:30 AM9:25 AM

Session 10: Important Risks

9:25 AM10:00 AM

Session 11: Beyond the US and EU

11:15 AM12:00 PM

Session 13: Compliance

1:00 PM1:20 PM

Session 14: More on Compliance

1:50 PM2:15 PM

Session 16: CEO Engagement

2:45 PM3:45 PM

Session 17: Shades of Grey

3:45 PM4:15 PM

Questions, Wrap-Up, and Review of Learner Assessment

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