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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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CSS: This year's PHUSE/FDA CSS from the 19-21 September will take place at the Civic Centre, Silver Spring, MD .
The three days will focus on Working Group activities, a highly successful poster session and several networking events. A regulatory plenary session will take place where we will hear from the FDA and EMA regarding data. In addition to these presentations, there will also be two sessions relating to the Office of New Drugs release of standard tables and figures and standard adverse event groupings and queries! There will be two workshops held over the three days, for more information take a look on the PHUSE website where you can find the full agenda and how to register!
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Save the date! 5 October 2022 – The Emerging Trends & Technologies Working Group presents the next Community Forum: Ingestion and Standardization of Real-World Data.
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Recently Published Deliverables
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The Central Monitoring Capabilities project, under the Risk Based Monitoring Working Group have drafted a White Paper titled: Centralized Monitoring: Exploring the Considerations and Challenges of Implementation. The paper describes common obstacles to implementing centralized monitoring (CM), while providing insight and guidance to address those difficulties to enable CM to be a key component to a successful risk based monitoring approach. It covers topics such as CM implementation models, CM change management, the central monitor role, and the execution of CM activities. The team is respectfully calling for public feedback on the White Paper. Please submit any feedback by 6 September to workinggroups@phuse.global.
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The Safety Analytics Working Group, are looking for members to join a project to provide consolidated PHUSE feedback on the standard tables and figures and standard adverse event groupings and queries packages, for more information see here. If you are interested in joining the team please email workinggroup@phuse.global.
For information on the PHUSE Working Groups and their projects, click here.
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AE Groupings in Safety (AEGiS) – Project Members
The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). As noted in the FDA Clinical Review Template (Section 7.1.2 in Attachment B) and the EU SmPC Guideline and emphasised in the 2017 PHUSE adverse events white paper, adverse event categorisation that is too granular can result in underestimation of an event (e.g. somnolence, drowsiness, sedation and sleepiness probably all refer to the same event). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables and figures). Note this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a white paper and/or publishing in a peer-reviewed journal.
If you are interested in participating in this project, 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 – 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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The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative. This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you. You can find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.
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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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