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DIA 2021 Global Annual Meeting

Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond

Session Chair(s)

Elektra Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

  • Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
  • FDA, United States
Remote clinical outcome assessments (COAs) enable conduct of decentralized trials and played a pivotal role in adapting trials during the COVID-19 pandemic. A multi-stakeholder panel will discuss considerations for implementing COAs remotely.
Learning Objective : Describe considerations for remote implementation of COAs during and after COVID-19; Discuss opportunities and challenges to implement remote COAs in clinical trials; Discuss key aspects of data collection and analysis when using remote COAs.

Speaker(s)

Isaac R Rodriguez-Chavez, MHS, PhD, MS

Industry Update

Isaac R Rodriguez-Chavez, MHS, PhD, MS

  • Senior Vice President, Scientific and Clinical Affairs, Head, Global COE
  • ICON plc, United States
Maria Tome, MD, PhD, FFPM

EMA Update

Maria Tome, MD, PhD, FFPM

  • Pharma Medicine Physician, Senior Scientific Advisor, Scientific Advice
  • European Medicines Agency, Netherlands
Kai Langel

Industry Update

Kai Langel

  • Senior Director, Strategy and Innovation, Global Regulatory Policy
  • Janssen, Spain