Cape Stephanie, Islam Rafiq, Nehls Corey, Allinson John, Safavi Afshin, Bennett Patrick, Hulse James, Beaver Chris, Khan Masood, Karnik Shane, Caturla Maria Cruz, Lowes Steve, Iordachescu Adriana, Silvestro Luigi, Tayyem Rabab, Shoup Ron, Mowery Stephanie, Keyhani Anahita, Wakefield Andrea, Li Yinghe, Zimmer Jennifer, Torres Javier, Couerbe Philippe, Khadang Ardeshir, Bourdage James, Hughes Nicola, Awaiye Kayode, Matthews Brent, Fatmi Saadya, Johnson Rhonda, Satterwhite Christina, Yu Mathilde, Lin Jenny, Cojocaru Laura, Fiscella Michele, Thomas Eric, Kurylak Kai, Kamerud John, Lin Zhongping John, Garofolo Wei, Savoie Natasha, Buonarati Mike, Boudreau Nadine, Williard Clark, Liu Yansheng, Warrino Dominic, Kale Prashant, Adcock Neil, Shekar Radha, O'Connor Edward, Ritzen Hanna, Sanchez Christina, Hayes Roger, Bouhajib Mohammed, Savu Simona Rizea, Stouffer Bruce, Tabler Edward, Tu Jing, Briscoe Chad, der Strate Barry van, Rhyne Paul, Conliffe Phyllis, DuBey Ira, Yamashita Jim, Tang Daniel, Groeber Elizabeth, Vija Jenifer, Malone Michele, Osman Mohamed
Covance, Madison, WI, USA.
Celerion, Lincoln, NE, USA.
Bioanalysis. 2017 Apr;9(7):505-516. doi: 10.4155/bio-2017-5000. Epub 2017 Mar 24.
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO-Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.
第十届全球合同研究组织理事会（GCC）闭门论坛于2016年4月18日在美国佛罗里达州奥兰多市举行。出席会议的有提供生物分析服务的国际CRO成员公司的决策者。本次会议的目的是让GCC成员相聚并讨论生物分析特有的科学和监管问题。在这个闭门论坛上讨论的问题包括失败的方法验证运行的数据报告、临床样本生物分析的GCP、提取样本的稳定性、生物标志物分析验证、处理批次验收标准、电子实验室笔记本和数据完整性、加拿大卫生部关于基质稳定性评估中重复实验的通知、关键试剂以及打击欺诈的监管方法。为了获取制药行业对其中一些主题的观点，2016年11月12日在美国科罗拉多州丹佛市举行了首次CRO - 制药行业科学交流会议。在这次交流会议上讨论的五个主题是失败的方法验证运行的数据报告、临床样本生物分析的GCP、提取样本的稳定性、处理批次验收标准以及电子实验室笔记本和数据完整性。本报告包含了这两次会议上对这些主题讨论的结论。
