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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. |
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Thats a wrap on the Data Transparency Winter Event 2023! PHUSE would like to thank all presenters, sponsors and attendees who helped to make this year's Winter Event a huge success. If you did attend, please complete the short feedback survey to share your thoughts on the event. If you did not get the chance to attend, all content is available to view on the PHUSE archive.
Save the Date! The 2023 Data Transparency Summer Event will take place 20–22 June.
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Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March
During this Community Forum, you’ll hear about various efforts related to interactive safety reviews. The presentation will be followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. Register here!
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Real World Evidence: Requirements and Recommendations for Regulatory Submissions – the Real World Evidence project is calling for feedback on their most recent White Paper. In this paper, the RWE project aims to provide an overview of the learnings, challenges, and best practices around RWD data sources, collection, cleaning, standardisation, reporting and regulatory submissions. This paper also aims to serve as a reference for relevant guidelines and articles related to the use of RWD/RWE for regulatory submissions. Please provide your comments directly into the document or send them to workinggroups@phuse.global by 20 March.
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The Nonclinical Topics Working Group is on the lookout for members to join the Conformance with the Tumor.xpt Specification project. The aim of this project is to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification. This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file.
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Management of ODS Regulatory Referenced Deliverables: Do you have experience in creating the BDRG or SDSP? If so, then the Optimising the Use of Data Standards Working Group needs you! This recently formed project is on the lookout for new members to ensure regulatory referenced deliverables are kept up to date with regulatory guidance's and to carry out updates as needed. To apply for this project, click here to submit an application form.
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Click here to view the additional 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.
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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 – Call For Speakers | ||
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The Data Transparency Working Group invites abstract submissions 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. Focus your submission on these central themes and submit an abstract by 8 May to contribute to the discussion. Click here for more information.
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Real World Data Autumn Event – Call For Speakers | ||
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We’re excited to announce Call for Speakers for the Real World Evidence Working Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from 09:00–11:30 (EDT) / 14:00–16:30 (BST) / 15:00–17:30 (CEST). Submit your abstract by 8 May for the chance to present. Focus your submission on these central themes:
Click here for more information.
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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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