4th GCC Closed Forum for Bioanalysis (at the AAPS)

The 4th GCC Meeting for Bioanalysis at the AAPS was a whole day meeting taking place on October 23, 2011 in Washington, DC, USA.
It was chaired by Dr. Steve Lowes and attended by 38 CRO representatives representing 33 CRO member companies.
 
Based on the votes of member companies, the following 5 topics were chosen and were discussed during this meeting:
 
    • GCC survey/action plan on stability data co-administered & co-formulated drugs - led by Steve Lowes
    • Sharing Recent 483s or other Agencies findings and issuing recommendations - led by Bob Nicholson
    • The new EMA Bioanalytical Guidance published August 1 2011 - led by Philippe Couerbe 
    • Implications/ramifications from Recent FDA Warning letter: Approach to perform "pre-conditioning” of the instruments before sample analysis and how to avoid test into compliance? - led by Roger Hayes
    • Implications/ramifications from Recent FDA Warning letter: How to prevent “pre-enter” time/initial from bioanalytical employees? - led by Roger Hayes 

 

A Meeting Report/White Paper including all the resolutions of this GCC Closed Forum will be generated, signed off by all the official representatives and published shorlty!

    Sign in|Report Abuse|Print Page|Remove Access|Powered By Google Sites