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DoubleTree by Hilton Hotel Toronto Downtown

Sep 28, 2015 8:00 AM - Sep 30, 2015 4:30 PM

108 Chestnut Street, Toronto, ON M5G 1R3, Canada

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Agenda

Day 1 Sep 28, 2015

8:00 AM — 9:45 AM

Overview; Module 01: Drug Safety: History and Basics; Module 02: International Safety Harmonization Activities and Key Regulatory Authoritie

10:00 AM — 12:15 PM

Session 03: Canadian Pre-and Postmarketing Legislation; Session 04: Overview of Regulations in the US and EU

1:00 PM — 2:30 PM

2:45 PM — 5:15 PM

Session 08: Good Case Report Management/Key Performance Indicators; Session 09: Good Clinical Practices; Q & A

Day 2 Sep 29, 2015

8:00 AM — 10:15 AM

Session 10: Drug Safety in Clinical Trials; Session 11: Roles of IRBs and DSMBs

10:30 AM — 11:45 AM

12:30 PM — 2:45 PM

3:00 PM — 5:15 PM

Day 3 Sep 30, 2015

8:00 AM — 11:00 AM

Session 18: Postmarketing Spontaneous Reporting System; Session 19: Good Pharmacovigilance Practice in US and EU

11:00 AM — 12:30 PM

Session 20: Safety Signals; Session 21: Pharmacoepidemiology Study for Signal Assessment

1:15 PM — 2:00 PM

2:00 PM — 3:15 PM

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