The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), will release new resources for adopting a Quality by Design (QbD) approach for clinical trials in a free public webinar on Thurs., Nov. 12, 2020, from 11:00 am – 12:00 pm EST.
Developed by leaders and stakeholders across the clinical trials ecosystem, these new tools – a maturity model, metrics framework, implementation guide, and documentation tool – can help research organizations appropriately plan, implement, and demonstrate the value of QbD. This approach helps researchers focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.
These new resources expand CTTI’s existing QbD toolkit, which 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.
In this webinar, attendees will receive an introduction to why QbD matters in the regulatory landscape and in enhancing engagement with patients and other key stakeholders, as well as insight from industry experts on the new QbD resources framework and a case study discussion around the impact of QbD on trial design. The webinar will culminate with a Q&A session.
The webinar presenters include:
· Greg Pennock, EMD Serono
· David Rodin, Amici Clinical Research
· Karlin Schroeder, Parkinson’s Foundation
· Ansalan Stewart, U.S. Food and Drug Administration
· Steve Young, CluePoints
Call to Action: Follow the link to register here.