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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 


 

Instructors:

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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