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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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Registration for the PHUSE/FDA CSS 2024 is open!
Come and be a part of the PHUSE/FDA Computational Science Symposium 2024 (CSS) taking place 3–5 June in Silver Spring, MD. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate. Be sure to register by 15 March to use the PHUSE Early Bird discount!
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Real World Evidence | ||
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Community Forum: Capturing the Patients Voice Through Lived Experience Across Diaries and Social Media 23 April 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (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) / |
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Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global.
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Instructions for submitting your questions via the BIMO FAQ Survey:
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We look forward to receiving your BIMO questions!
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The SDTM ADaM Implementation FAQ project within Optimizing the Use of Data Standards wants to answer more of your SDTM ADaM questions! There are many questions related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). The project's team currently:
1. Collect frequently asked questions (FAQs) from Industry.
2. Assess the appropriateness of a question, develop and review a response, collaborate with CDISC/FDA for clarity if required.
3. Publish the FAQ and responses on the Advance Hub database for helpful implementation/strategy information.
If you have any questions for the team, please contact: workinggroups@phuse.global. You can find the previous questions that have been answered on the project page, under Objectives & Deliverables.
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Volunteer Opportunities
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The goal of this Working Group is to work together to identify and close those particular gaps that impede industry and the FDA from making the most efficient use of data standards. Click here to see a list of current projects within this Working Group.
Learn more about the roles and the responsibilities of a Working Group Lead and apply by emailing workinggroups@phuse.global. Closing date 29 March.
The Nonclinical Topics Working Group has initiated a new Project called ‘Supporting the Use of SEND for the Implementation of Virtual Control Groups’ which is now calling for volunteers! This project will leverage the deep SEND knowledge and experience of the PHUSE Nonclinical Topics Working Group by initially focusing on the development of best practices with respect to population of SEND datasets with data from virtual control animals. This project will be working alongside the Nonclinical Scripts project also within the Nonclinical Topics Working Group and provide an open venue for the socialisation and hosting of open-source software solutions related to selection procedures and database infrastructure. If you are interested in joining, please contact workinggroups@phuse.global. Closing date 13 April.
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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Emerging Trends & Innovation |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & InnovationWorking Group has published a new White Paper titled “Capturing Computational Workflows in Clinical Trials with BioCompute” This white paper explores how the BioCompute framework can transform the way computational workflows are captured and communicated in clinical trials. As bioinformatics analyses become increasingly complex, consistent and transparent documentation is essential for reproducibility and regulatory confidence. Through practical case studies, the paper demonstrates how BioCompute enables structured, auditable workflows across diverse data types, including omics and imaging, while supporting more efficient collaboration and regulatory submissions. |
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The RWD Guideline for Programming and Analysis Processes Project within the Real World Evidence Working Group has published a new White Paper. This paper offers practical guidance for statistical programmers on applying real‑world data (RWD) to produce regulatory‑grade real‑world evidence (RWE), covering study design, data fitness, governance, ethics, vendor engagement, bias management, and regulatory submission considerations. |
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Real World Evidence – Calling For Feedback |
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The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 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, 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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PHUSE Communications
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Working Groups Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group.
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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.
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