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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. |
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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 |
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email workinggroups@phuse.global. |
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Once again we celebrate another successful PHUSE/FDA CSS! Thank you to all the 200+ attendees who helped to ensure the first in-person CSS since the Covid-19 pandemic, was one to remember.
PHUSE/FDA CSS will return for a 12th year so stay tuned for 2023 dates to be announced soon! For more information on PHUSE Working Groups, please contact workinggroups@phuse.global.
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Thank you to all attendees!
The Emerging Trends & Technologies Working Group hosted the latest Community Forum:
Ingestion and Standardisation of Real-World Data. The free, virtual event took place 5 October 2022.
This community forum discussed the options and challenges when using and standardizing a variety of available real-world data sources including the corresponding data models and ingestion methods.
Questions and discussions took place after each topic as well as a general Q&A at the end.
Couldn't attend? Ensure you don't miss out! Catch up by viewing the recording.
We encourage everyone to get involved in the online Disqus forum. Here, you can have your say, ask presenters any questions and carry on the conversation.
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Recently Published Deliverables
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The Analyses & Displays for Laboratory Data project (Safety Analytics) has recently published a White Paper with recommendations for analyses and displays for laboratory data, with a focus on Phase II to IV clinical trials and integrated submission documents. There have been two previous white papers (2013 and 2015). The latest white paper (August 2022) provides updated recommendations. You can view the White Paper here.
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The SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under SDTM/ADaM IG Nuances. The question is based on the handling of transgender patients in clinical trials.
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For information on the PHUSE Working Groups and their projects, click here.
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The Office of New Drugs (OND) in the FDA Center for Drug Evaluation and Research (CDER) will release documents for public review on standard adverse event groupings and queries for evaluation of biologic/new drug applications.
In addition to their breakout sessions at PHUSE/FDA CSS 2022 to discuss initial feedback, the Safety Analytics Working Group are currently looking for members to join their brand new project. This project will provide consolidated PHUSE feedback on the standard tables and figures as well as standard adverse event groupings and queries packages. If you are interested in joining, please contact workinggroup@phuse.global.
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Best Data Practices for Rare Disease Patient Foundations and Researchers, part of the Emerging Trends & Technologies Working Group, is looking for members to join their project to create a guidance about best data practices for patient foundations and for researchers in the form of decision trees, graphics, short printable materials or videos. Please contact workinggroup@phuse.global for more information.
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Working Groups Q1 Reports |
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We’re excited to share the latest update highlighting the fantastic progress across our Working Groups. This quarter’s report showcases key achievements from our Projects and highlights the important and innovative work that’s still underway. Explore the full report to see how each Project is making an impact. Don’t miss the detailed overview of the events and milestones that shaped this quarter’s journey. |
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pharmaverse | ||
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pharmaverse Hackathon Series Featuring the {xportr} Package Hackathon Kick-Off – 12 May 09:00–10:00 (EDT) / 14:00–15:00 (BST) / 15:00–16:00 (CEST)
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Real World Evidence | ||
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Webinar: Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes 21 May 11:00-12:00 (EDT) / 16:00-16:00 (BST) / 17:00-18:00 (CEST)
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Data Transparency Autumn Event – Save the Date |
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The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data. Registration will open 17 June. |
Real World Data Autumn Event – Save the Date |
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Join us for the return of the Real World Evidence Working Group’s multi‑day virtual event on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST). Registration will open 17 June. |
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Nonclinical Topics – Calling For Feedback |
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The Conformance with the tumor.xpt Specification within the Nonclinical Topics Working Group has produced a White Paper ‘Conformance with the Technical Specifications Document for Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals’ along with a set of Conformance Rules. This White Paper outlines the development of standardised conformance rules for tumor.xpt datasets to enable automated validation, improve data consistency, and reduce manual effort in regulatory submissions for carcinogenicity studies.. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 20 May 2026. |
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If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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Working Group 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. |
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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, |
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biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit |
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Working Groups Latest Report Q2 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.
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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.
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