GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline supplement

Bioanalysis Zone is delighted to announce that Bioanalysis have published the ‘GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline’ supplement written by the Global CRO Council for Bioanalysis (GCC).  This supplement presents the GCC’s collaborated feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline, published in February 2019, gathered from the 13^th GCC Closed Forum (LA, USA, 5 April 2019).

At the forum, 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies analyzed the newest ICH M10 Bioanalytical Method Validation Draft Guideline, working through the document, line by line, to provide thorough feedback on each point. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.

Click here to read the full supplement, published in Bioanalysis

Thoughts on ICH M10

The ICH M10 Bioanalytical Method Validation Draft Guideline is a globally important topic for all bioanalysts. Read what some of the key thought leaders think about the GCC consolidated feedback to the ICH in the interviews linked below:

GCC ICH M10: thoughts from Roger Hayes
Vice President of Bioanalytical Service
ICON plc (NY, USA)

GCC ICH M10: thoughts from Stephanie Cape
Associate Director of Bioanalytical Scientific Operations
Covance (WI, USA)

GCC ICH M10: thoughts from Chad Briscoe
Executive Director of Bioanalytical Science
PRA (NC, USA)

GCC ICH M10: thoughts from Rafiq Islam
Executive Director of Bioanalytical Services
Celerion (NE, USA)
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GCC ICH M10: thoughts from Mike Buonarati
Senior Director
Intertek Pharmaceutical Services (CA, USA)

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Panel discussion: ICH M10 draft bioanalytical method validation guideline