2016 ADX
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Archived Content

Short Course 9
Regulatory Compliance in Drug Diagnostics Co-Development
Monday, August 18 | 5:30pm - 8:30pm | Capital Hilton Hotel | Washington DC

Instructors:

Tracy Bush, Ph.D., Director & Global Coordinator, Companion Diagnostics, Regulatory Affairs, Roche Diagnostics


Pamela L. SwatkowskiPamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.





Sabah MalekSabah 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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