Difference between revisions of "2018 CSS Nonclinical Topics Outcomes"

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THIS SITE IS UNDER CONSTRUCTION
 
 
==WELCOME==
 
==WELCOME==
 
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  ||Maintaining the SDRG: Clinical and Nonclinical Workshop
 
  ||Maintaining the SDRG: Clinical and Nonclinical Workshop
  || • Workshop Outcome
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  || • [[File:SDRG Workshop Outcomes 5Mar2018.pptx|Workshop Outcome]]
 
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| Monday - NCT WG Intro session  
 
| Monday - NCT WG Intro session  
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• [http://www.phusewiki.org/wiki/images/d/d8/BO3_Improving_Info_Accessability_-_Wiki_discussion_outcome.pptx Improving the NCT WIKI - discussion outcome]
 
• [http://www.phusewiki.org/wiki/images/d/d8/BO3_Improving_Info_Accessability_-_Wiki_discussion_outcome.pptx Improving the NCT WIKI - discussion outcome]
 
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| Tuesday - Breakout 4 – Future Value|| What is on the horizon for implementation challenges? ||[http://www.phusewiki.org/wiki/images/c/c1/SEND_Development_Status_CDISC_presentation_CSS_2018.pdf CDISC SEND Development Status CSS2018]
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| Tuesday - Breakout 4 – Future Value|| <br />
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What is on the horizon for implementation challenges?<br />
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||[http://www.phusewiki.org/wiki/images/c/c1/SEND_Development_Status_CDISC_presentation_CSS_2018.pdf CDISC SEND Development Status CSS2018]
 
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|CSS Outcomes|| New Projects - agreed proposal List ||• Improving the NCT WIKI<br />
 
|CSS Outcomes|| New Projects - agreed proposal List ||• Improving the NCT WIKI<br />

Revision as of 18:58, 16 April 2018

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 File:SDRG Workshop Outcomes 5Mar2018.pptx
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)