GCC Closed Forum on CoA White Paper

Virtual

14th GCC Closed Forum For Bioanalysis

To Be Announced Soon

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

9th GCC: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks - This Conference Report was published on Bioanalysis Journal

WHITE PAPER - Recommendations on Incurred Sample Stability (ISS) by GCC - This White Paper was published on Bioanalysis Journal

WHITE PAPER - Recommendations on Biomarker Bioanalytical Validation by GCC - This White Paper was published on Bioanalysis Journal

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