Difference between revisions of "2018 CSS Nonclinical Topics Outcomes"

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| Session || Title|| Presentation Links
 
| Session || Title|| Presentation Links
 
|-
 
|-
| NCT WG Intro session  
+
| <br />
 +
Sunday - Eve Workshop<br />
 +
 
 +
||Maintaining the SDRG: Clinical and Nonclinical Workshop
 +
|| • Workshop Outcome
 +
|-
 +
| Monday - NCT WG Intro session  
 
  ||Working Group Keynote Speaker: Lilliam Rosario, FDA
 
  ||Working Group Keynote Speaker: Lilliam Rosario, FDA
 
  || • [http://www.phusewiki.org/wiki/images/6/6d/PhUSE_CSS_2018_Nonclinical_Rosario_Lilliam_-_flattened.pdf|Nonclinical Bringing It All Together]<br />
 
  || • [http://www.phusewiki.org/wiki/images/6/6d/PhUSE_CSS_2018_Nonclinical_Rosario_Lilliam_-_flattened.pdf|Nonclinical Bringing It All Together]<br />
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| Monday – Breakout 2 – Industry Impact Perspectives||Industry Impacts of e-data implementation –experience and expectations<br />
 
| Monday – Breakout 2 – Industry Impact Perspectives||Industry Impacts of e-data implementation –experience and expectations<br />
 
• Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements.
 
• Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements.
|| • Discussion outcomes:  
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|| • [http://www.phusewiki.org/wiki/images/6/65/E-data_Implementation_Impact_Panel_Discussion_Summary_final.pptx Discussion outcomes: Pharma-CRO-Regulatory-Vendor-Consultants]
Pharma-CRO-Regulatory-Vendor-Consultants
 
 
|-
 
|-
 
| Tuesday - Breakout 3 – Future Ways of Working || Solving nonclinical data challenge of Toxicology data sharing initiatives ||  • [http://www.phusewiki.org/wiki/images/9/9a/PhUSE-CSS-eTOX_eTRANSAFE_Presentation.pdf eTransafe presentation] <br />
 
| Tuesday - Breakout 3 – Future Ways of Working || Solving nonclinical data challenge of Toxicology data sharing initiatives ||  • [http://www.phusewiki.org/wiki/images/9/9a/PhUSE-CSS-eTOX_eTRANSAFE_Presentation.pdf eTransafe presentation] <br />

Revision as of 18:53, 16 April 2018

THIS SITE IS UNDER CONSTRUCTION

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)