2018 CSS Nonclinical Topics Outcomes

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WELCOME

A big THANKS to attendees and their companies for investing in attendance to the 2018 CSS this year.


The Nonclinical Topics Working Group had the biggest turnout ever (>70), filling up the big conference space.

With all that brain power, experience and enthusiasm, the experience was truly valuable!

AGENDA and Presentations

Session Title Presentation Links

Sunday - Eve Workshop

Maintaining the SDRG: Clinical and Nonclinical Workshop • Workshop Outcome
Monday - NCT WG Intro session Working Group Keynote Speaker: Lilliam Rosario, FDA Bringing It All Together

Outcome of Lilliam’s question: What can we do to help?

Monday – Breakout 1 – Project Recognition Nonclinical Topics Delivering Over the Past Year Data consistency

Nonclinical scripts BW gain presentation
Project status presentations
2017 SEND Implementation Survey

Monday – Breakout 2 – Industry Impact Perspectives Industry Impacts of e-data implementation –experience and expectations

• Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements.

Discussion outcomes: Pharma-CRO-Regulatory-Vendor-Consultants
Tuesday - Breakout 3 – Future Ways of Working Solving nonclinical data challenge of Toxicology data sharing initiatives eTransafe presentation

Biocelerate presentation
Improving the NCT WIKI - discussion outcome

Tuesday - Breakout 4 – Future Value What is on the horizon for implementation challenges? CDISC SEND Development Status CSS2018
CSS Outcomes New Projects - agreed proposal List • Improving the NCT WIKI

• Linked Data Education

• Modeling Flow Cytometry in SEND

(project requests to be created)