2018 CSS Nonclinical Topics Outcomes

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

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.

Tuesday - Breakout 3 – Future Ways of Working Solving nonclinical data challenge of Toxicology data sharing initiatives Example
Tuesday - Breakout 4 – Future Value What is on the horizon for implementation challenges? Example
Example Example Example