16th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status
- This paper has just been published on Bioanalysis Journal

Recommendations on qPCR/ddPCR Assay Validation by GCC
- This White Paper was published on Bioanalysis Journal

Recommendations on ELISpot assay validation by the GCC
- This White Paper was published on Bioanalysis Journal

Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis
- This White Paper was published on Bioanalysis Journal

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
- This Paper was published on Bioanalysis Journal

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
- This Conference Report has just been published on Bioanalysis Journal

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
- This White Paper has just been published on Bioanalysis Journal

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation
- Conference Report from the 11th GCC Closed Forums - Published in Bioanalysis Journal

10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
- Conference Report from the 10th GCC Closed Forums - Published in Bioanalysis Journal

9th GCC Closed Forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks
- Conference Report from the 9th GCC Closed Forums - Published in Bioanalysis Journal

8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation
- Conference Report from the 8th GCC Closed Forums - Published in Bioanalysis Journal

7th GCC Insights: Incurred Samples Use, Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing
- Conference Report from the 7th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on Incurred Sample Stability (ISS) by GCC
- White Paper from the 7th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on Biomarker Bioanalytical Validation by GCC
- White Paper from the 5th and 6th GCC Closed Forums - Published in Bioanalysis Journal

6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
- Conference Report from the 6th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
- White Paper from the 4th, 5th and 6th GCC Closed Forums - Published in Bioanalysis Journal

Recommendations on ISR in multi‑analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)
- White Paper from the 5th GCC Closed Forum at the EBF - Published in Bioanalysis Journal

Coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover
- Conference Report from the 4th GCC Closed Forum at AAPS - Published in Bioanalysis Journal

Recommendations on the Interpretation of the new EMA Guidline on BMV by GCC for Bioanalysis
- White Paper from the 4th GCC at the AAPS and 5th GCC at the EBF - Published in Bioanalysis Journal

The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum
- Meeting Report from the 3rd GCC Closed Forum at the Reid Bioanalytical Forum - Published in Bioanalysis Journal

Recommendations on: Internal Standard Criteria; Stability; ISR and Recent 483s by the Global CRO Council (GCC) for Bioanalysis
- White Paper from the 2nd GCC Closed Forum at the 5th WRIB - Published in Bioanalysis Journal

Formation of a Global CRO Council (GCC) for Bioanalysis
- Meeting Report from the 1st GCC Closed Forum - Published in Bioanalysis Journal