CTTI will unveil official recommendations of the Quality by Design (QbD) Project at the DIA’s 51st Annual Meeting in Washington, DC. Quality by Design is an approach to clinical development that prospectively examines the objectives of a clinical trial and defines factors critical to meeting those objectives. These recommendations and an associated toolkit will assist organizations to implement QbD principles within their trials.
Additionally, at this conference, CTTI will share preliminary findings from projects on data monitoring committees, IND safety reporting, recruitment, and patient group engagement. As always, we look forward to connecting with our colleagues at this event. See below for details regarding CTTI’s presence at #DIA2015:
Session: Clinical Quality by Design: From Theory to Practice
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Ann Meeker-O’Connell, Chair (Janssen), Coleen Glessner (Pfizer), Jean Mulinde (CDER/FDA), James Streeter (Oracle Health Sciences)
Session: The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps
Date: June 15, 2015 from 11:00 AM – 12:30 PM
Presenters: Susan Ellenberg, Chair (University of Pennsylvania), Ray Bain (Merck), Karim Calis (FDA), Jane Perlmutter (Patient Representative)
Session: Translating New Knowledge from Regulatory Science into Postmarketing Safety Practice
Date: June 16, 2015 from 3:30 PM – 5:00 PM
Presenters: Gerald Dal Pan, Chair (FDA), Michael Jones (Eli Lilly), Darrell Abernethy (FDA), Peter Richard Arlett (EMA)
Session: Best Practices for Effective Engagement with Patient Groups Around Clinical Trials
Date: June 17 from 3:30 PM – 5:00 PM
Presenters: Bray Patrick-Lake, Chair (CTTI), Wendy Selig (WSCollaborative), Matthew Harker (CTTI), David Leventhal (Pfizer)
Poster: Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruitment
Date: June 16 & 17 from 9:00 AM – 4:00 PM
Presenters: Jamie Roberts (CTTI), Elizabeth Mahon (Janssen)
For a complete list of CTTI’s upcoming events, please click here.