Overview

This talk will give an overview of recent FDA efforts in the area of Complex Innovative Clinical Trial Designs (CID). Topics covered will include FDA’s final guidance on Adaptive Design Clinical Trials for Drugs and Biologics, FDA’s draft guidance on Interacting with FDA on Complex Innovative Trial Designs, and the FDA pilot review program for CID. The webinar will serve as a preview for the upcoming 3/2/20 – 3/3/20 DIA workshop “Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients".

This on demand webinar recording is approximately 1 hour long.

Featured topics

FDA’s final guidance on Adaptive Design Clinical Trials for Drugs and Biologics
FDA’s draft guidance on Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biologics
FDA’s pilot review program for Complex Innovative Trial Designs

Who should attend?

Professionals who work in the area of:

Biostatistics
Clinical research
Regulatory affairs

Learning objectives

At the conclusion of this on demand content preview webinar, participants should be able to:

Identify key FDA guidance efforts in the area of complex innovative clinical trial design

Continuing Education Credits are not available for this event.

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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.