PhUSE European Computational Science Symposium

London, United Kingdom

19th & 20th June 2017


The 2017 PhUSE EU CSS took place at the Grange Tower Bridge in London. This two day meeting was attended by industry and regulatory attendees who came together to collaborate on three key topics. 

The meeting kicked off with keynote presentations from Crystal Allard, FDA and Trish Groves, The BMJ followed by breakout sessions on Data Transparency, Nonclinical Topics and Optimizing the Use of Data Standards. The meeting concluded with a panel discussion led by the FDA and EMA.

Keynote Presentations:

How PhUSE Collaborations Assist Regulatory Review – Crystal Allard, FDA

Why Data Sharing from Clinical Trials Really Matters – Trish Groves, The BMJ

Working Group Presentations:

Optimizing the Use of Data Standards

Data Transparency Working Group

 

Data Transparency Presentations:

Policy 007: Where we Are – Karen Quigley, EMA

 

Nonclinical Topics Presentations:

SEND in the Review Template – Elaine Thompson

Fit for Use Pilot – Elaine Thompson

SEND Data Visualisation using SEND Explorer – Marc Ellison

Importance of semantic Integration and Data Service Layers for Interactive Data Visualisation – Nicholas Phillippe

Visualisation from SEND Data Warehouse – Bob friedman

EU CSS 2017 – Lilliam Rosario

FDA Validation Rules Implementation – Sergiy Sirichenko

PhUSE EU nSDRG Overview – nSDRG Working Group

Define.xml Content for SEND – Rachel Harper

Study Data Standardisation Plan – Sandra Johanssen

IMI and eTOX an Overview – Phil Drew

IMI2 and NetGETS an Overview – Phil Drew

 

Panel Discussion

Panel Discussion Notes – FDA & EMA

 

 

Event Sponsors:

                       

 

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