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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 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 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 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) / 16:00-17:30 (CET).
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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) / 9:00-10:30 (EDT) / 15:00-16:30 (CET).
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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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The "Emerging Trends and Technology" (ET&T) Working Group is changing its name! This Working Group will now be called "Emerging Trends and Insights" (ET&I). Hear from one of the Working Group's Leads, Mike Hamidi, on why they are making this change:
"The proposed name change from Emerging Trends & Technologies to Emerging Trends & Insights reflects a broader focus beyond just technological enablement. This shift encompasses not only ongoing developments in areas such as AI/ML, digital health technologies, and healthcare standards but also aims to provide deeper insights into these and other evolving topics. We believe this adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights."
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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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Working Group Q4 Reports |
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The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact. Revisit the events from this quarter and explore what’s coming up next. |
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Real World Evidence |
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Community Forum: The Causal Roadmap,Targeted Learning and TMLE: What Is That All About? 29 January 2026 at 10:00-11:00 (EST) / 15:00-16:00 (GMT) / 16:00-17:00 (CET) |
Nonclinical Advance Event | ||
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026 at 09:00–11:30 (EST) / 14:00–16:30 (GMT) / 15:00–17:30 (CET) We have an exciting agenda of expert presentations, interactive breakout sessions and project updates, spread across three days. The event will focus on four core themes – new approach methodologies (NAMs), nonclinical predictive modelling, machine learning and PHUSE project contributions and developments – and enable attendees to explore each topic in depth with leaders from industry, regulatory agencies and the wider PHUSE Community. Full agenda and registration details coming soon!
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Data Transparency Autumn Event – Save the Date |
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We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026. Stay tuned for more details and registration information coming soon! |
Real World Data Autumn Event – Save the Date |
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We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026. Stay tuned for more details and registration information coming soon! |
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QC Workflow Optimisation | ||
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The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group have published a survey exploring the current state of Quality Control across the industry. This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project. The survey will remain open from 3 December – 13 January. All responses will be collected anonymously.
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The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
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. |