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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. 

RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards – 12 April
Hear from presenters as they dive 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 will explore 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.

Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March
The Safety Analytics Working Group presented on the various efforts related to interactive safety reviews. Catch up by viewing the recording and head over to the Disqus Forum to share your thoughts and ask the presenters your questions. Just log in with your Disqus, Facebook, Twitter or Google account to get started! 

The SDTM ADaM Implementation FAQ project recently received a question under Data Submission on submitting a table of hyperlinked outputs, program files and input data source of trials to the FDA. Click here to read the response! If you have a question for the team, email workinggroups@phuse.global. 

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. 

Click here to view projects within Working Groups which are open to join. 
If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global. 

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. 

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.