1. WELCOME!
Nonclinical Topics Working Group
CSS Breakout Plan

2. 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)
Mission and Principles
Preview upcoming activities
Working Group Keynote Speaker: Lilliam Rosario, FDA
12-1
Lunch
1-2:30 – Breakout 1
Fit for Use: Industry Feedback Panel Discussion – chaired by Kathy Brown, Maria Francomacaro
Sponsor Panel to present experiences from Fit For use Pilot
Data Consistency Challenges
Discussion forum on ways to improve SEND implementations
2:30-3 (estimated)
Break
3-4:30 – Breakout 2
“Functionalizing” Data Visualizations via Scripts – chaired by Alan Brown, William Houser
Opportunities with different tools
Discussion on General Session FDA presentation as relevant to visualization
Some contingency time
5-6:30
Poster Session

3. Tuesday Date/Time 8:30-10 – Breakout 3
PhUSE and CDISC Collaboration – We’re Not Silos! – chaired by Lou Ann Kramer, Chris Decker
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
How far has industry advanced since last year
Surface ideas for ways PhUSE can support implementation challenges
10-10:30
Break
10: – Breakout 4
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
Lunch
1-2 – Working Group Wrap up