The 6th GCC Meeting for Bioanalysis at the WRIB was a whole day meeting taking place on March 27, 2012 in San Antonio, TX, USA.It was chaired by Bob Nicholson and attended by 46 CRO representatives representing 33 CRO members
Agenda of the Meeting:
07:00am-08:00am
Breakfast and Registration
08:00am-08:10am
Opening Remarks, Admonition Statement, and Participants' introduction
08:10am-08:40am
" Updates on the Co-ad open letter "
– Chaired by Steve Lowes08:40am-09:30pm
" Bridging and qualification strategies for critical reagents, positive controls, and reference standards following lot changes "
– Chaired by Dan Mamelak and Afshin Safavi09:30am-10:00am
Morning Refreshment Break
10:00am-11:00am
" Feedbacks on the GCC recommendations on EMA guideline "
– Chaired by Maria Caturla11:00am-12:00pm
" How are we demonstrating convincing specificity for endogenous analytes "
– Chaired by Rafiqul IslamAccess the Survey on Specificity for Endogenous Analytes
12:00pm-01:00pm
Lunch
01:00pm-02:30pm
" Biomarker recommendation: Continuing the discussions on Assay qualification and validation: attaining clear definitions in relation to biomarker assays "
– Chaired by John AllinsonAccess the Survery on Biomarker
02:30pm-03:00pm
" Acceptance criteria for LC-MS-based assay validation and sample analysis: should we follow large molecule or small molecule convention "
– Chaired by Bob Nicholson03:00pm-03:00pm
Afternoon Wine and Cheese Break (of course also coffee and sweets)
03:30pm-03:45pm
New Regulatory Findings
– Open Discussions Chaired by Bob Nicholson03:45pm-04:45pm
Bioanalytical approach for biosimilars
– Chaired by Masood Khan and Dominique GoutyAccess the Survey on Biosimilar
04:45pm-05:15pm
Be ready for the New FDA Draft Guidance – Preparing the next GCC Closed Forum at the Crystal City Meeting – Building sub teams based on topics
– Chaired by Bob Nicholson04:45pm-05:15pm
GCC Financial Report
– Reported by Wei GarofoloDue to the Welcome Reception of 6th WRIB from 5:30pm to 6:30pm on March 27, the traditional GCC Member Reception will be postponed to be held on Thursday March 29 at the Hotel Bar from 6pm to 9pm. Please drop by the hotel bar to continue the informal discussions and networking with other members.