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Thursday, July 1 • 11:30am - 12:30pm
#421 SL: Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-647-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Elektra Papadopoulos, MD, MPH

Speaker

Industry Update
Isaac R Rodriguez-Chavez, MHS, PhD, MS

EMA Update
Maria Tome, MD, PhD, FFPM

Industry Update
Kai Langel



Speakers
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Senior Vice President, Scientific and Clinical Affairs, Head, Global COE, PRA Health Sciences, United States
Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical... Read More →
avatar for Kai Langel

Kai Langel

Director, Clinical Innovation, Janssen, Spain
Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational... Read More →
avatar for Elektra Papadopoulos

Elektra Papadopoulos

Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on... Read More →
avatar for Maria Tome

Maria Tome

Pharma Medicine Physician, Senior Scientific Advisor, Scientific Advice, European Medicines Agency, Netherlands
Dr. Tome serves as Senior Scientific Officer at the Product Development and Scientific Support Department of the European Medicines Agency (EMA). EMA can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine's benefits and risks... Read More →


Thursday July 1, 2021 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session