AGENDA
October 1, 2021 - Virtual
| 08:00am-08:20am: | Opening Remarks, Admonition Statement, and Participants’ introduction – Natasha Savoie |
| 08:20am-09:20am: | “ELISpot Assay Validation - Recommendations from GCC (target White Paper)” – Session Leader: Rafiq Islam |
| 09:20am-09:50am: | “Is the Sciex 7500 the new standard for Bioanalytical CRO?” – Session Leader: Allan Xu |
| 09:50am-10:20am: | Short Break |
| 10:20am-10:50am: | “Bioanalytical Run Efficiency” – Session Leaders: Stephanie Cape, Mark O’Dell |
| 10:50am-11:50am: | “qPCR/ddPCR Assay Validation - Recommendations from GCC (target White Paper)” – Session Leader: Christina Satterwhite |
| 11:50am-12:20pm: | “Hybrid LBA/LCMS Methods - Bioanalytical Method Validation (BMV) Requirements” – Session Leaders: William Mylott, Moucun Yuan |
| 12:20pm-01:00pm: | Short Break |
| 01:00pm-02:00pm: | “Biomarkers Assay Validation (BAV) - BMV or CLIA?” – Session Leaders: Mark O'Dell, Eric Thomas, Mark Arnold |
| 02:00pm-02:30pm: | “Updating Documentation at CRO” – Session Leaders: Stephanie Cape, Steve Lowes |
| 02:30pm-03:00pm: | “Run Re-injection” – Session Leader: Shane Karnik |
| 03:00pm-03:30pm: | Short Break |
| 03:30pm-04:00pm: | “Singlicate” – Session Leader: Rafiq Islam |
| 04:00pm-05:00pm: | “Recent Findings/483s Cases” and “What would you do - Dilemma Cases” – Session Leaders: Jennifer Vance, Jennifer Vija; Speakers on Individual Topics: Edward Tabler, Roger Hayes, Hao Wang |
| 05:40pm: Meeting | Adjourn |