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Tutorial #1: Statistical Methods for Safety Surveillance
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TUTORIAL
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Sunday, Apr 28
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9:00AM - 12:30PM
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IACET
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Tutorial #2: Missing Data in Clinical Trials
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TUTORIAL
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Sunday, Apr 28
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1:30PM - 5:00PM
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IACET
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Tutorial #3: Benefit-Risk Evaluation
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TUTORIAL
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Sunday, Apr 28
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1:30PM - 5:00PM
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ACPE, IACET
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Welcome and Opening Remarks
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SESSION
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Monday, Apr 29
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8:45AM - 9:00PM
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ACPE, IACET
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Keynote Address
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SESSION
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Monday, Apr 29
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9:00AM - 10:30AM
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ACPE, IACET
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Session 01 - PDUFA V Overview
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SESSION
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Monday, Apr 29
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11:00AM - 12:30PM
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ACPE, IACET
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Session 2 - Missing Data: When is it important to collect data after study drug discontinuation?
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SESSION
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Monday, Apr 29
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1:30PM - 3:00PM
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ACPE, IACET
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Session 03 - Missing Data: Case Study Presentation & Panel Discussion
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SESSION
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Monday, Apr 29
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3:30PM - 5:00PM
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ACPE, IACET
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Session 4 - Statisticians as Leaders
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SESSION
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Tuesday, Apr 30
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8:30AM - 10:00AM
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ACPE, IACET
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Session 5 - Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks
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SESSION
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Tuesday, Apr 30
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10:30AM - 12:00PM
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ACPE, IACET
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Luncheon and Roundtable Discussions
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SESSION
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Tuesday, Apr 30
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12:00PM - 1:30PM
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Session 6 - (Pre-Marketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review
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SESSION
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Tuesday, Apr 30
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1:30PM - 3:00PM
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ACPE, IACET
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Session 7 - Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies
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SESSION
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Tuesday, Apr 30
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3:30PM - 5:00PM
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ACPE, IACET
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Networking Reception and Poster Session
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SESSION
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Tuesday, Apr 30
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5:00PM - 7:00PM
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Session 8 - Companion Diagnostics
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SESSION
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Wednesday, May 01
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8:30AM - 10:00AM
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ACPE, IACET
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Session 9 - Meta Analysis for Safety Data
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SESSION
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Wednesday, May 01
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10:30AM - 12:00PM
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ACPE, IACET
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Session 10 - Pre-Competitive Collaboration
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SESSION
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Wednesday, May 01
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1:00PM - 2:30PM
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ACPE, IACET
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Overview and Commentary of FDA Guidances: Enriched Populations
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SESSION
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Wednesday, May 01
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3:00PM - 4:30PM
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ACPE, IACET
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