WELCOME! Nonclinical Topics Working Group CSS Breakout Plan

WELCOME! Nonclinical Topics Working Group CSS Breakout Plan

WELCOME! Nonclinical Topics Working Group CSS Breakout Plan Date/Time Monday 11-12 Nonclinical Topics Working Group intro session, chaired by Sue DeHaven and Patty Brundage Welcome 10 min Remarks (30-40 min) o Mission and Principles o Preview upcoming activities o Working Group Keynote Speaker: Lilliam Rosario, FDA Lunch Fit for Use: Industry Feedback Panel Discussion chaired by Kathy Brown, Maria Francomacaro Sponsor Panel to present experiences from Fit For use Pilot o Data Consistency Challenges o Discussion forum on ways to improve SEND implementations

Break Functionalizing Data Visualizations via Scripts chaired by Alan Brown, William Houser o Opportunities with different tools o Discussion on General Session FDA presentation as relevant to visualization o Some contingency time 12-1 1-2:30 Breakout 1 2:30-3 (estimated) 3-4:30 Breakout 2 5-6:30 Poster Session Date/Time Tuesday 8:30-10 Breakout 3 PhUSE and CDISC Collaboration Were Not Silos! chaired by Lou Ann Kramer, Chris Decker o Joint discussion of nonclinical standards development hot topics and

related implementation support opportunities Results Presentation of 2017 SEND Readiness Survey chaired by George Kahlbaugh, Lou Ann Kramer o How far has industry advanced since last year o Surface ideas for ways PhUSE can support implementation challenges 10-10:30 10:30 -12 Breakout 4 Break Update on Industry Consortiums: (*may be moved to Tues, pending schedule) Transcelerate/Biocelerate William Houser IMIeTox/NextGets Phil Drew Project Reviews and Selections for upcoming year chaired by Sue DeHaven, Patty Brundage Past year Project updates with decisions on continue or close Analysis and decision on new project ideas 12-1 1-2 Working Group Wrap up Lunch

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