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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 Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The third webinar will take place on 14 September on the topic of 'Safety Analytics Webinar Series: Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest'. Click here to register, a list of all upcoming webinars and previous webinars can be found here.

The Real World Evidence Working Group will be hosting another Community Forum, 5 October 14:00–15:00 (BST) 09:00–10:00 (EDT). Presentations will be on the topic of 'Experiences with Adapting RWD to CDISC Submission Standards'. During this Community Forum, presenters will share their experiences and the challenges they encountered along with the solutions they came up with when working with RWD and CDISC standards. Register here!

Data Transparency Working Group's new project Anonymization of Imaging Data is now calling for volunteers. This project plans to complete a literature review on types of imaging files including (X-rays, (f)MRIs, CT scans, etc.), their formats (DICOM, NIfTI, etc.), their positions (limbs, heads, organs, etc.) and all associated metadata. There will also be a discussion on data handling, storage and transfer. Any existing guidance and repositories will be reviewed. We will then focus on use cases that will have the most impact based on interest and complexity. 

The Comparing Analysis Method Implementations in Software (CAMIS) project, within the PHUSE Data Visualisation & Open Source Technology Working Group would like to hear from you on your experience on Statistical Method implementation across different programming languages (SAS/R/Python/Julia etc). Please complete this survey by 11 September. 

The Quality tolerance Limits Project, within the Risk Based Monitoring Working Group is currently looking for a new co-Lead. The team are working on developing a white paper which is analysing the results of their recent survey. The project aims to define role of QTLs in QbD, in particular the relationship to CTQs (Critical to Quality Factors), Estimands and continuous quality improvement (CQI), Discuss the use of QTLs in Early Development/small studies, bio equivalence and complex designs Discuss examples of how to define QTLs, different methodologies and different parameters in use across the industry, Discuss difficulties and challenges of implementation of QTLs and Examine role of QTLs as part of the of the lessons learned (RCA) feedback loop. Please contact workinggroups@phuse.global to register your interest. 

Please contact workinggroups@phuse.global to register your interest in volunteering.

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. 

Working Groups Report: Includes project updates, recent and upcoming deliverables and the 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.