2023 - How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA/ePRO)

Over the last six months new guidance has been released by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regarding ethics committee (EC) submission, decentralized trials, patient-focused drug development, electronic systems and computerized systems. Although some are in draft format, this regulatory guidance is (indirectly) helping to advance and enhance the use of eCOA e.g., maintaining data quality in decentralized trials or electronic submission to ethics committees.
In the webinar, the Clario eCOA Science team will share their interpretation of the new guidance and how the combination of these together with scientific input can help sponsors and biotechnology companies achieve a more patient-centric approach while maintaining data integrity in a flexible trial environment.
Agenda
Overview of new/changed guidances
EU Clinical Trials Regulation (Jan 2023)
FDA (Draft) Decentralized Clinical Trials for Drugs, Biological Products and Devices (May 2023)
FDA (Draft) Q&A Document “Electronic Systems, Electronic Records and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023)
FDA (Draft) Guidance Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (April 2023)
EMA (Final) Guideline on Computerized Systems and Electronic Data in Clinical Trials (March 2023)
How the new guidance could potentially help advance and enhance the use of eCOA/ePRO
A deeper dive into the nuances of submission requirements for European Ethics Committees/IRB
Join this webinar to discover how the recent FDA & EMA regulations are helping advance and enhance electronic clinical outcome assessments (eCOA/ePRO).