Full Program

Title: Tutorial #1: Statistical Methods for Safety Surveillance
Event Type: TUTORIAL
Credits: IACET
Day: Sunday, Apr, 28
Time: 9:00AM - 12:30PM
Title: Tutorial #2: Missing Data in Clinical Trials
Event Type: TUTORIAL
Credits: IACET
Day: Sunday, Apr, 28
Time: 1:30PM - 5:00PM
Title: Tutorial #3: Benefit-Risk Evaluation
Event Type: TUTORIAL
Credits: ACPE, IACET
Day: Sunday, Apr, 28
Time: 1:30PM - 5:00PM

Title: Welcome and Opening Remarks
Event Type: SESSION
Credits: ACPE, IACET
Day: Monday, Apr, 29
Time: 8:45AM - 9:00PM
Title: Keynote Address
Event Type: SESSION
Credits: ACPE, IACET
Day: Monday, Apr, 29
Time: 9:00AM - 10:30AM
Title: Session 01 - PDUFA V Overview
Event Type: SESSION
Credits: ACPE, IACET
Day: Monday, Apr, 29
Time: 11:00AM - 12:30PM
Title: Session 2 - Missing Data: When is it important to collect data after study drug discontinuation?
Event Type: SESSION
Credits: ACPE, IACET
Day: Monday, Apr, 29
Time: 1:30PM - 3:00PM
Title: Session 03 - Missing Data: Case Study Presentation & Panel Discussion
Event Type: SESSION
Credits: ACPE, IACET
Day: Monday, Apr, 29
Time: 3:30PM - 5:00PM

Title: Session 4 - Statisticians as Leaders
Event Type: SESSION
Credits: ACPE, IACET
Day: Tuesday, Apr, 30
Time: 8:30AM - 10:00AM
Title: Session 5 - Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks
Event Type: SESSION
Credits: ACPE, IACET
Day: Tuesday, Apr, 30
Time: 10:30AM - 12:00PM
Title: Luncheon and Roundtable Discussions
Event Type: SESSION
Day: Tuesday, Apr, 30
Time: 12:00PM - 1:30PM
Title: Session 6 - (Pre-Marketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review
Event Type: SESSION
Credits: ACPE, IACET
Day: Tuesday, Apr, 30
Time: 1:30PM - 3:00PM
Title: Session 7 - Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies
Event Type: SESSION
Credits: ACPE, IACET
Day: Tuesday, Apr, 30
Time: 3:30PM - 5:00PM
Title: Networking Reception and Poster Session
Event Type: SESSION
Day: Tuesday, Apr, 30
Time: 5:00PM - 7:00PM

Title: Session 8 - Companion Diagnostics
Event Type: SESSION
Credits: ACPE, IACET
Day: Wednesday, May, 01
Time: 8:30AM - 10:00AM
Title: Session 9 - Meta Analysis for Safety Data
Event Type: SESSION
Credits: ACPE, IACET
Day: Wednesday, May, 01
Time: 10:30AM - 12:00PM
Title: Session 10 - Pre-Competitive Collaboration
Event Type: SESSION
Credits: ACPE, IACET
Day: Wednesday, May, 01
Time: 1:00PM - 2:30PM
Title: Overview and Commentary of FDA Guidances: Enriched Populations
Event Type: SESSION
Credits: ACPE, IACET
Day: Wednesday, May, 01
Time: 3:00PM - 4:30PM

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