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#1 - Pharmacovigilance and Risk Management Planning
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TUTORIAL
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Sunday, Jan 13
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8:30AM - 12:00PM
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ACPE, IACET, RN
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#2 - Development Safety Update Reports (DSURs): Principles and Practicalities
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TUTORIAL
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Sunday, Jan 13
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8:30AM - 12:00PM
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IACET, RN
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#3 -ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs)
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TUTORIAL
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Sunday, Jan 13
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1:30PM - 5:00PM
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IACET, RN
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#4 - Pharmacovigilance System Master File
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TUTORIAL
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Sunday, Jan 13
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1:30PM - 5:00PM
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IACET, RN
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Conference Welcome
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SESSION
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Monday, Jan 14
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8:45AM - 9:00AM
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CME, IACET, RN
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Program Committee Opening Remarks
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SESSION
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Monday, Jan 14
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9:00AM - 9:15AM
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CME, IACET, RN
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Session 1 - Keynote Presentation
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SESSION
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Monday, Jan 14
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9:15AM - 10:00AM
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CME, IACET, RN
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Session 2 – FDA Updates
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SESSION
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Monday, Jan 14
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10:30AM - 12:00PM
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ACPE, CME, IACET, RN
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Session 3 – What’s New in Japan – Practicalities of Implementation of Risk Management Plans (RMPs)
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SESSION
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Monday, Jan 14
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1:30PM - 3:00PM
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CME, IACET, RN
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Session 4 – Debate: Controversies in Pharmacovigilance – Blind or Unblind
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SESSION
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Monday, Jan 14
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3:30PM - 5:00PM
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ACPE, CME, IACET, RN
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Session 5 – New EU Regulations – Part A – Regulatory Overview
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SESSION
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Tuesday, Jan 15
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8:30AM - 10:00AM
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CME, IACET, RN
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Session 6 – New EU Regulations – Part B – Industry View/Impact
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SESSION
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Tuesday, Jan 15
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10:30AM - 12:00PM
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CME, IACET, RN
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Session 7 – Benefit-risk Analysis – Operational Challenges
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SESSION
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Tuesday, Jan 15
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1:30PM - 3:00PM
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CME, IACET, RN
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Session 8 – Panel Debate: Will We Ever Move Towards More Quantitative Benefit-risk Analysis?
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SESSION
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Tuesday, Jan 15
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3:30PM - 4:30PM
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CME, IACET, RN
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Session 9 – Other International Regulatory Updates
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SESSION
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Wednesday, Jan 16
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8:30AM - 10:00AM
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CME, IACET, RN
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Session 10 – Epidemiology
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SESSION
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Wednesday, Jan 16
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10:30AM - 12:00PM
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ACPE, CME, IACET, RN
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Session 11 – Social Media Panel Discussion
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SESSION
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Wednesday, Jan 16
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1:30PM - 3:00PM
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ACPE, CME, IACET, RN
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