(264c) Quality By Design and Expedited Development Programs
- Conference: AIChE Annual Meeting
- Year: 2020
- Proceeding: 2020 Virtual AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Friday, November 20, 2020 - 9:10am-9:20am
The regulatory dossier must capture elements of the development process, it must show how our clinical drug product links to the commercial drug product and it must outline our control strategies for commercial manufacturing. This presentation will highlight the successes and challenges of rapid drug development and how our global regulatory dossier has evolved to deal with these complexities.
Kevin Fitzpatrick is an employee of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.