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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.

The PHUSE Data Transparency (DT) Summer Event will take place 20–22 June. Become a presenter and have your chance to reach the wider data transparency community. Submit your abstract to workinggroups@phuse.global before Call for Speakers closes on 21 April. Click here for further details. 

PHUSE are extremely proud to welcome the eighth PHUSE Working Group; Real World Evidence. The importance of this industry area has become increasingly apparent over recent years and the launch of this Working Group honours that. Working Group leads, Berber Snoeijer and David Hood, are looking forward to kicking off with exciting projects on real-world data sources, code and analysis techniques, and submission requirements. 

• Quality and Reusability of Real-world Data
• Real World Evidence Guidance
• Submitting Real-world Data 

To volunteer for one or more projects within the new Real World Evidence Working Group, contact workinggroups@phuse.global. 

Click here to view projects within Working Groups which are open to join. 

RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards – 12 April
In the most recent PHUSE Community Forum, presenters dived into what follows after using real-world data for regulatory submissions, and look into examples of mapping and data handling in two ways (OMOP to SDTM and source/SDTM to OMOP). They explored the challenges of mapping to and from OMOP, which is a more open standard than SDTM and uses a stricter model with strict implementation guides. Catch up by viewing the recording and posting your comments and questions to the Disqus forum. Just log in with your Disqus, Facebook, Twitter or Google account to get started! 

The Implementation of Estimands (ICH E9 (R1)) Using Data Standards project within the Optimizing the Use of Data Standards working group, is calling for your feedback to gain additional insights ahead of a white paper release later this year. Survey responses will also be summarised and shared at upcoming industry conferences, such as the DIA Global Annual Meeting in June. If you have any familiarity around Estimands at your organisation, we value your experience and insights! Click here to complete the survey before it closes on 14 April. 

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, biologic 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. 

Latest Working Groups Latest Report: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

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