Short Course 9
Regulatory Compliance in Drug Diagnostics Co-Development
Monday, August 18 | 5:30pm - 8:30pm | Capital Hilton Hotel | Washington DC
Tracy Bush, Ph.D., Director & Global Coordinator, Companion Diagnostics, Regulatory Affairs, Roche Diagnostics
Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.
Sabah Malek, Associate Director, Global Regulatory Affairs, Eisai, Inc.
Topics to be covered:
- U.S. requirements and processes
- U.S. government oversight of diagnostics, diagnostic clearance and approval pathways
- Co-development process & timelines
- Integration of Rx and Dx development plans
- Navigating the development process
- Co-development examples and lessons learned
- Diagnostics regulation in the EU, Japan, China and other complex emerging markets
- Developing a successful CDx global regulatory strategy
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