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
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

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

• Linked Data Education
• Modeling Flow Cytometry in SEND