A recording is now available of the public webinar held on Thurs., Nov. 12 to launch CTTI’s new resources for implementing a Quality by Design (QbD) approach to clinical trials. The webinar was led by Greg Pennock, EMD Serono; David Rodin, Amici Clinical Research; Karlin Schroeder, Parkinson’s Foundation; Ansalan Stewart, FDA; and Steve Young, CluePoints.
“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing , and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”
The specific resources that CTTI released include:
CTTI’s QbD toolkit serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.
Both the webinar and the new resources can be found on the CTTI website.