Dinner Short Course

Regulatory Compliance in Drug-Diagnostics Co-Development AND CONSIDERATIONS FOR NGS ASSAYS 

Sunday, February 9, 2014 | 2:00 - 5:00 pm | Moscone North Convention Center | San Fransisco, CA 



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






Maham AnsariMaham Ansari, MS, RAC, Consultant, Strategic Regulatory Services OptumInsight (UnitedHealth Group)







Melina CimlerMelina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, 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
  • Next generation sequencing applications and implications
  • Current regulatory pathways
  • Overview of things to consider in developing NGS applications for clinical use
  • NGS in companion diagnostics – roles of pharma and diagnostic partners
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