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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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Recommendations for Adverse Event Collection and Treatment Emergent Definition
In 2019, the PHUSE Best Practices for Data Collection Initiatives project team, in conjunction with the Analysis and Display of Safety Analytics project team, conducted a survey (link) to study the variation in the collection and definition of treatment emergent adverse events (TEAEs) in clinical studies. It noted the need to pursue additional research to further harmonise industry practices. The PHUSE Adverse Event Collection Recommendations and the Treatment Emergent Definitions Recommendations project teams were formed to develop recommendations to reduce the implementation variability.
Adverse Event Collection Recommendations: The PHUSE Adverse Event Collection Recommendations project team developed recommendations for the collection of adverse events which aim to improve the quality of the data and the site experience, as well as provide the data for treatment emergent definitions and for recommended analyses and displays. Earlier this year, the project team issued a white paper (link) documenting the recommendations. This webinar will provide an overview of the white paper, including time for Q&A.
Treatment Emergent Definitions Recommendations: The PHUSE Treatment Emergent Definitions Recommendations project team conducted a survey to solicit input from industry and regulatory respondents on various TEAE scenarios for a simple clinical study design. The project team developed a white paper (link) with recommendations for standardising the TEAE definition based on the survey results, as well as their collective experiences. This webinar will provide an overview of the white paper, including time for Q&A.
This webinar will be taking place over Zoom on 20 November at 15:00-16:30 (GMT) / 10:00-11:30 (EDT).
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Responsive Regulation of AI in Drug Development
The use of artificial intelligence (AI), including machine learning (ML), technologies across all stages of the drug product life cycle may accelerate the delivery of safe and effective high-quality drugs. As this data-driven technology continues to rapidly evolve across the landscape of drug development, a responsive regulatory approach may be warranted to calibrate the requirements needed to meet safety and evidentiary standards. This responsive regulatory approach can be based on an assessment of model risk, which is estimated by examining AI models’ influence on regulatory decision-making and the potential consequences of wrong decisions if the model is inaccurate. This responsive regulatory approach is rooted in an in-depth understanding of the specific application context and calibrates regulatory requirements in accordance with model risk.
Principles of trustworthy and responsible AI serve as the foundation for responsive policy development and provide valuable considerations for both AI tool developers and regulators. It is important to consider ways to continue to engage with all interested parties to remain responsive to the changing technological landscape. Scientific discussion around continuing our responsive risk-based regulation, our collaborative efforts across the AI ecosystem (i.e. academia, industry, biotech), and advancing regulatory science in this area, without adding unnecessary burden to developers or regulators, is warranted.
This webinar will be taking place over Zoom on 21 November at 14:00-15:30 (GMT) / 09:00-10:30 (EDT).
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Call for Speakers is closing soon for the Data Transparency Winter Event 2025!
Taking place virtually 4-6 February, this event presents an incredible opportunity to showcase your ideas, share insight and engage with a vibrant community dedicated to advancing data transparency in the industry.
For the chance to make a lasting impact, within a diverse network of like-minded individuals, submit your 150-word abstract before 15 November 2024.
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In its 14th year, the PHUSE/FDA Computational Science Symposium (CSS) will be expanding its global reach! In addition to Silver Spring, Maryland, we will be running a simultaneous event in Utrecht, the Netherlands!
Mark Your Calendars!
The US event will be in Silver Spring, Maryland 19-21 May, and the EU event will be in Utrecht, the Netherlands 20-21 May.
Please visit the PHUSE website for more information.
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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) / 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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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. |
Real World Evidence |
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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 |
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Volunteer Board and contact the PHUSE Office |
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on workinggroups@phuse.global to express your interest. |
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Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
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The Best Practices in Data Standards Implementation Governance project within the Optimizing the Use of Data Standards Working Group has published a new white paper.
This white paper presents the results of the survey along with feedback from informal discussions at the PHUSE/FDA Computational Science Symposium (CSS) sessions in 2022 and 2023. The data and observations shared are intended to inform industry and identify further projects for exploration while also encouraging industry collaboration for areas which are found to be the most challenging.
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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. |