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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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After the success of their last two events, the Emerging Trends & Technologies Working Group is back to kickstart the new year with yet another PHUSE Community Forum! Submitting Real-world Data takes place 18 January. Register here and get 2023 off to a great start with a free, PHUSE virtual event.
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Call for Questions!
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Do you have an industry question you’ve always wanted to know the answer to? Why not ask SDTM ADaM Implementation FAQ! The aim of this project is to collect frequently asked questions, and to develop and review a response, sometimes collaborating with CDISC and FDA. The team will then publish their response on the PHUSE Advance Hub. If you have a question for the team, please submit it via workinggroups@phuse.global.
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Recently Published Deliverables
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Visit the PHUSE website to view the extensive list of all published deliverables.
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The Educate the General Population project, part of the Data Transparency Working Group, aim to create engaging content that can be understood and used by the general population (any member of the public regardless of their sector or profession). The team have recently published two, out of a series of six, videos on data privacy and data sharing. The purpose of these videos is to answer frequently asked questions which will enable viewers to become more informed, thus helping to have a positive impact on their families and the wider community. The two videos are an Introduction and Importance of Clinical Trials. Please submit any feedback, to workinggroups@phuse.global.
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If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global.
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An exciting opportunity has arisen within the PHUSE Nonclinical Scripts project to collaborate with BioClelerate, the FDA and CDER for assistance with implementing the sendigR open-source package at your company. Collaborative team meetings will take place Fridays 8-9am EDT. Ideally, volunteers will have some programming experience (ie, python, unix/R) and some knowledge of internal SEND data storage. Click here for more information on the sendigR package and the benefits of working collaboratively. If you are interested in getting involved, please contact workinggroups@phuse.global.
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- Bioresearch Monitoring (BIMO) Frequently Asked Questions forum
- Best Data Practices for Rare Disease Patient Foundations and Researchers
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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 Q3/4 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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