It seems the combined industry efforts have finally paid off, Health Canada has just published an Addendum to the Oct. 8, 2015 Notice - http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice_avis_mthd_validation-eng.php#a1.
Following the release of the Health Canada Notice on October 8th, 2015, the CRO bioanalytical industry has come together to collate actual data and case studies on how bioanalytical labs are performing matrix-based stability evaluations. In an effort to determine how CRO labs perform these evaluations, and in preparation for the next Closed Forum meeting on April 2016 in Orlando, Florida, the Global CRO Council in Bioanalysis (GCC) has sent its membership a survey and collected responses from 40 Global CROs.
View Preliminary Evaluation of the GCC Survey Results on Health Canada Oct. 8th Notice - This Topic will be further discussed at the 10th GCC Closed Forum in April 2016 in Orlando.
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 - This Conference Report has just been published on Bioanalysis Journal
8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation - This Conference Report is published on Bioanalysis Journal
WHITE PAPER - Recommendations on Incurred Sample Stability (ISS) by the Global CRO Council (GCC) - This White Paper is published on Bioanalysis Journal
If you meet the following criteria, you can then simply register to attend the next GCC Closed Forum representing your CRO company and contribute to the discussions during the GCC Closed Forum, as well as providing your inputs representing your company to the Paper (either White Paper or Conference Report) that concludes the discussions of the GCC Closed Forum.
GCC Registration Inclusion Criteria: