CTTI Project: Quality by Design
Webinar Presenters:
- Jean Mulinde, U.S. Food & Drug Administration/CDER
- Annemarie Forrest, CTTI
- Hamid Moradi, University of California, Irvine
- Dan Cooper, University of California, Irvine
- Ann Meeker-O'Connell, IQVIA
Quality by Design
Designing High-Quality COVID-19 Treatment Trials
CTTI Project: Quality by Design
Webinar Presenters:
- Pamela Tenaerts (Clinical Trials Transformation Initiative)
- Janet Woodcock (FDA, CDER)
- Ed Cox (Regeneron Pharmaceuticals, Inc.)
- Martin Landray (University of Oxford)
- John Marshall (WHO Clinical Characterization and Management Working Group, Unity Health CA)
- Karlin Schroeder (Parkinson's Foundation)
- Fergus Sweeney (European Medicines Agency)
- Ann Meeker O'Connell (Vertex Pharmaceuticals)
Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials
CTTI Project: Quality by Design
Webinar Presenters:
- Greg Pennock, EMD Serono
- David Rodin, Amici Clinical Research
- Ansalan Stewart, FDA
- Karlin Schroeder, Parkinson’s Foundation
- Steve Young, CluePoints
Webinar Resources:
Resources:
- QbD Metrics Framework
- QbD Maturity Model
- QbD Maturity Model Walkthrough and Scoring Examples
- QbD Implementation Guide
- QbD Documentation Tool