Agenda
11:00 AM — 12:15 PM
Calling All Angels to the Valley of Death11:00 AM — 12:15 PM
Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies11:00 AM — 12:15 PM
GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial2:00 PM — 3:15 PM
Novel Techniques for Improving Clinical Trial Subject Retention2:00 PM — 3:15 PM
Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 24:00 PM — 5:15 PM
Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 24:00 PM — 5:15 PM
Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More10:30 AM — 11:45 AM
Multiregional Clinical Trials and the ICH E1710:30 AM — 11:45 AM
Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation4:00 PM — 5:15 PM
Safety Issues in First-in-Human Studies10:45 AM — 11:45 AM
Evolving Clinical Trial Guidance and Regulations: Am I Ready?10:45 AM — 12:00 PM
Of Course My Data Has Integrity … And I Can Prove It10:45 AM — 12:00 PM
Trial Master File: MHRA/EMA Inspections and Sponsor Audit LearningsHave an account?