12th GCC Closed Forum for Bioanalysis

April 9, 2018, Downtown Philadelphia, PA, USA

Sheraton Downtown Philadelphia

07:00am-08:00am : Breakfast and Registration

08:00am-08:15am : Opening Remarks, Admonition Statement, and Participants’ introduction – Natasha Savoie

08:15am-09:00am : “Cumulative Stability” Topic Leader: Stephanie Cape, Mark Arnold

09:00am-09:30am : “Health Canada Oct. 8th Notice - Compiling Data From All Cros And Put Together A Position Paper/ White Paper” Topic Leaders: Rafiq Islam

09:30am-10:00am : Morning Coffee and Refreshment Break

10:00am-10:30am : “2016 Immunogenicity Guidance And Recent And Unexpected 483s On Immunogenicity Assays” Topic Leader: Joe Bower, Bruce Stouffer

10:30am-11:30am : “Bioanalytical Laboratory's Role In Writing Pk Sample Collection Instructions” Topic Leader: Roger Hayes, Mark Warren, Shane Karnik

11:30am-12:15pm : “Biosimilar - Regulatory Feedback” Topic Leader: Rafiq Islam, Yi Qun Xiao, Barry Van Der Strate, Dan Sikkema

12:15pm-01:15pm : Buffet Lunch outdoor at Ballroom Circle

01:15pm-02:00pm : “Cro Perspective On Use Of Chiral Vs Achiral Methods” – Topic Leaders: Chad Briscoe

02:00pm-02:45pm : “Hybrid Lba/Lcms Assays” Topic Leader: Stephanie Cape, Mark Arnold

02:45pm-03:30pm : Wine and Cheese, and Ice Cream Break (of course also coffee and sweets)

03:30pm-05:00pm : “Applications Of Fit-For-Purpose (Ffp) Validation” Topic Leaders: Chad Briscoe, Joe Bower, Pat Bennett

05:00pm-05:20pm : “Status and Trend of Current Regulated Bioanalytical Practice in China under CFDA’s New BMV Policy” Topic Leader: XinPing Fang

05:20pm Meeting Adjourn and Welcome Reception of WRIB starts at 5:30pm at Hilton