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

Expert opinion Regulated bioanalysis
Female hand with microphone on color background

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 13th 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:

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

IMG_2078 (2)GCC ICH M10: thoughts from Stephanie Cape
Associate Director of Bioanalytical Scientific Operations
Covance (WI, USA)

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

Bio Pic_rafiq (2)GCC ICH M10: thoughts from Rafiq Islam
Executive Director of Bioanalytical Services
Celerion (NE, USA)
[column size = “1/3”]

mike (3)GCC ICH M10: thoughts from Mike Buonarati
Senior Director
Intertek Pharmaceutical Services (CA, USA)

If you enjoyed these interviews, you might also like..

Feature-WRIB

Panel discussion: ICH M10 draft bioanalytical method validation guideline

 

 

 

Our expert opinion collection provides you with in-depth articles written by authors from across the field of bioanalysis. Our expert opinions are perfect for those wanting a comprehensive, written review of a topic or looking for perspective pieces from our regular contributors.

See an article that catches your eye? Read any of our articles below for free.