Expected Outcome

All the GCC meetings will be dedicated to bringing many CRO leaders together to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry, with the following expected outcome:

  • Understand options of how we can work together to present a cohesive "CRO face" to the top level decision makers in regulatory bodies;
  • Feedback on recent concerns about upcoming developments or potential developments in regulated bioanalysis;
  • Assessment of whether we are all in agreement on interpretation of regulatory language;
  • Latest understanding of the specific challenges we are under (as an outsource provider lab) when trying to meet regulatory expectations;
  • Network with other CRO leaders.
  • A channel to communicate with global regulatory agencies.

A report/white paper including all the resolutions of each GCC Closed Forum will be generated at the end of each meeting, signed off by all the official participants and published.