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PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global.


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The Quality and Reusability of Real World Data project within the Real World Evidence Working Group has published its third Blog Post, RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making. This Blog will explore the main messages in the regulatory guidance, what challenges we foresee in applying it, and how registry data can be used in regulatory applications.

You can learn more about this project and read their previous blogs here.



Open Forum: What is the True Cost of Open Source?

TheOpen Source Technology in Clinical Data Analysis (OSTCDA) projectis hosting an Open Forum called What is the True Cost of Open Source.This forum will hear from Mike Stackhouse, who will cover a range of topics related to the following questions:

  • What is the true cost of adopting open-source tooling for clinical trial data analysis?
  • Can the industry fund open-source?

This Forum will be taking place over Zoom on 13 September at 15:00-16:00 (BST) / 10:00-11:00 (EDT).

 

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Working Groups Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group.

Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.

PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. 



Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

  • The projects must address significant research issues relevant to Computational Science
  • The project must not attempt to address FDA policy issues
  • There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.