Difference between revisions of "2018 CSS Nonclinical Topics Outcomes"

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| NCT WG Intro session  
 
| 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 />
 
• [http://www.phusewiki.org/wiki/images/a/a0/What_can_Do....._with_Pic.pptx Outcome of Lilliam’s question: What can we do to help?]
 
• [http://www.phusewiki.org/wiki/images/a/a0/What_can_Do....._with_Pic.pptx Outcome of Lilliam’s question: What can we do to help?]
 
|-
 
|-
 
|Monday  – Breakout 1 – Project Recognition|| Nonclinical Topics Delivering Over the Past Year||• [http://www.phusewiki.org/wiki/images/8/8a/Data_Consistency_-_SEND_Datasets_and_Study_Reports_Wiki_Deck.pdf Data consistency]<br />
 
|Monday  – Breakout 1 – Project Recognition|| Nonclinical Topics Delivering Over the Past Year||• [http://www.phusewiki.org/wiki/images/8/8a/Data_Consistency_-_SEND_Datasets_and_Study_Reports_Wiki_Deck.pdf Data consistency]<br />
• Nonclinical scripts BW gain presentation<br />
+
[http://www.phusewiki.org/wiki/images/7/76/PhUSE_CSS_2018_BW_Gain_NonclinicalScript_Presentation.pdf Nonclinical scripts BW gain presentation]<br />
 
• [[Nonclinical_Topics_Working_Group|Project status presentations]]<br />
 
• [[Nonclinical_Topics_Working_Group|Project status presentations]]<br />
 
• [http://www.phusewiki.org/wiki/images/7/70/2017_PhUSE_SEND_Survey_Results_-_CSS_Final_%281%29.pdf 2017 SEND Implementation Survey]<br />
 
• [http://www.phusewiki.org/wiki/images/7/70/2017_PhUSE_SEND_Survey_Results_-_CSS_Final_%281%29.pdf 2017 SEND Implementation Survey]<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.
|| Example
+
|| • Discussion outcomes:
 +
Pharma-CRO-Regulatory-Vendor-Consultants
 
|-
 
|-
| Tuesday - Breakout 3 – Future Ways of Working || Solving nonclinical data challenge of Toxicology data sharing initiatives || Example
+
| 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 />
 +
 
 +
• [http://www.phusewiki.org/wiki/images/e/e6/PhUSE_US_CSS_2018_-_BioCelerate_Presentation_-_2018-02-23.pdf Biocelerate presentation]<br />
 +
 
 
|-
 
|-
| Tuesday - Breakout 4 – Future Value|| What is on the horizon for implementation challenges? || Example
+
| 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]
 
|-
 
|-
 
| Example || Example || Example
 
| Example || Example || Example
 
|}
 
|}

Revision as of 12:50, 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
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
Example Example Example