CDx, NGS & Regulation – Webinar & Workshop

4 months ago

The Pistoia Alliance is examining the challenges of the Development of Faster, Safe, Regulatory-compliant, Companion Diagnostics (CDx) using Next Generation Sequencing (NGS). EMQN is contributing to this discussion.

Can the data standards and methods used in the research environment be aligned better with the data standards and methods used in the regulated environment? If so, the time and cost of the development of safe NGS-based CDx could be reduced.

Workshop – Wednesday 11th April: The Pistoia Alliance CDx, NGS & Regulation Workshop at the Royal Society of Chemistry, Piccadilly, London.

Speakers will introduce different perspectives on this challenge viz:

  • Regulatory Agency – Stephen Lee, Senior Regulatory Policy Manager, MHRA
  • Quality in Genetic Testing – Simon Patton, EMQN
  • Notified Bodies – Liz Harrison, Technical Team Manager, BSI Group
  • Pharma – John Whittaker, VP Target Discovery, GSK
  • CDx – Stewart McWilliams, VP Quality & Regulatory Affairs, Almac

and breakout sessions involving all workshop delegates will attempt to identify opportunities for pre-competitive collaboration to address some of these optimisation opportunities. A copy of the agenda can be downloaded from HERE.

Please Register your interest in attending the workshop, or scan the image below.

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