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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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Data Transparency Winter Event 2025
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Active since 2014, PHUSE’s Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field.
The PHUSE Data Transparency Winter Event took place on 4–6 February 2025. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. During this virtual event, presentations were delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There was also a panel discussion and Q&A session focused on the day's themes. Links to the event presentations and daily recordings can be found /wiki/spaces/WEL/pages/91979777.
Real World Data Spring Event 2025 | ||
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We're thrilled to announce a new Working Group event coming your way in 2025 – the PHUSE Real World Data Spring Event! "It will bring together engaged speakers from the field ranging from data vendor and data registry representatives to pharmaceutical and biotech industry representatives who are sharing their knowledge and ideas around Real World Data utilisation in a fast-moving and challenging environment." -Berber Snoeijer, ClinLine – Real World Evidence Working Group Lead The Real World Data Spring Event will take place on 9–10 April 2025 14:00-16:30(GMT) / 9:00-11:30(EST) / 15:00-17.30(CET)
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PHUSE Computational Science Symposium (CSS) 2025 | ||||
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In its 14th year, the /wiki/spaces/WEL/pages/38993921 will be in Utrecht, the Netherlands 20-21 May. Please visit the PHUSE website for more information. If you have groundbreaking research, innovative methodologies or impactful case studies, we've got an exciting opportunity for you! Poster Presentations provides an opportunity to cover any of the Stream topics in a visual and engaging manner. The Poster Session is an opportune time for networking and asking fellow CSS attendees for feedback on your work. Posters are ideal for presentations that include graphics, source code, statistical or thought-provoking concepts, novel data management or handling techniques, and innovative ways to implement data standards. Posters increase visibility, allow participants to review at their own pace and enable conversation about the topics presented. The Poster Session is taking place on 20 May and will offer an unparalleled platform to showcase your work, receive valuable feedback and engage in Q&A with attendees. Submit a 150-word abstract by 28 February.
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New Risk Based Quality Management Lead! |
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Please Welcome Jennifer Khron as a new Risk Based Quality Management lead. Jennifer Krohn, MS, currently serves as Associate Director, RBQM at Gilead Sciences. In her role, Jenn advises study teams on implementing risk-based monitoring strategies and leads initiatives working to develop enhanced technology and processes for centralised monitoring, risk assessments and site monitoring approaches. This role expands upon her 16 years’ experience in the CRO sector, where she spent a decade helping build centralised monitoring, leading data analyst teams and serving as QTL BPO. Prior to the RBQM space, Jenn worked in a variety of clinical trial roles across a wide range of therapeutic areas, from the site level as study coordinator, to the CRO side in clinical operations (CRA), data management and feasibility. Jenn previously co-led the Central Monitoring project, under the PHUSE RBQM Working Group. She holds a master’s degree in biology with a focus in biochemistry and physiology from the University of North Carolina Wilmington. |
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Announcement - Emerging Trends and Technologies Working Group Has Changed its Name!
There’s been an exciting change in Working Groups recently…
The Emerging Trends and Technologies Working Group has officially evolved into the Emerging Trends and Innovation Working Group!
Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope:
"The name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond technological enablement. This shift encompasses ongoing developments in areas such as AI/ML, digital health technologies and healthcare standards and aims to provide deeper insights into these and other evolving topics. This adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations.”
We are equally excited to welcome Mark Bynens, the new Working Group Lead. He joins Mike Hamidi and Stuart Malcolm, expanding the team’s expertise and capacity.
Mark Bynens brings a wealth of experience as Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development at Johnson & Johnson. Mark leads initiatives in change management, project management, education, high-performance computing, and statistical research.
Learn more about the Working Group Leads and their efforts here.
Would you like to get involved in Working Groups? Check out the new Project Volunteer Board to view all opportunities.
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published two new FAQs! They have answered a FAQ with Data Submission, the FAQ answered looks at the ‘Correct Implementation of the Define-XML Standard for Submission Purposes – ADaM and SDTM Variable Alignment’ and ‘Correct Implementation of the Define-XML Standard for Submission Purposes – Clarifications Needed’. You can view this question and see the FAQ's this project has answered so far here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
The Submitting Real World Data project within the Real World Evidence Working Group, has published a Blog. This Blog post explores possible approaches for submission of real world data to regulatory bodies. Real world data, as defined by the Food and Drug Administration in their guidance, comprises data collected from non-interventional study designs. (1) From project group discussions, ‘claims’ and ‘electronic health records’ comprise most real world data used in providing clinical evidence. Fast Health Interoperability Resources, or FHIR, is a platform used by HL7 for health information exchange. (2) This platform is widely used to exchange healthcare information, as far as claims and EHR data is concerned. As a result, a significant portion of real world data used by the pharma/biotech industry follows HL7-FHIR. |
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The Using OMOP and Other Real World Data Standards to Support Regulatory Submissions, a new project within the Real World Evidence Working Group, is calling for volunteers.
The project includes developing awareness of data standards specific to real-world data to support regulatory purposes. Common data models (CDMs) and taxonomies that are specific to the most commonly used real-world data sources by industry, member companies and regulatory bodies across the globe will be in scope, such as electronic health record sources, patient-reported outcomes, widely accepted claims data sources, and other commonly used observational data. OMOP and the OHDSI community will be the focus, and will be evaluated against other CDMs and standards (such as PCORnet, Sentinel and CDISC).
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 March.
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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. |
Optimizing the Use of Data Standards |
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data StandardsWorking Group is pleased to announce that all published FAQ’s are now available on the PHUSE Deliverable website. Click here to view the categories of answered FAQs. |
Real World Evidence |
We are pleased to announce that Elena Valkanova will be taking over as the new Real World Evidence Working Group Lead. Elena began her career in clinical research more than 20 years ago, specialising in statistical programming and data analysis across diverse therapeutic areas. Throughout her career, she has contributed to the design, validation and reporting of regulatory deliverables, ensuring accuracy, reproducibility and compliance with global standards such as CDISC. Her early academic research into algorithmic game theory focused on developing randomised and strategy-improvement algorithms for simple stochastic games – a rare class of combinatorial problems that lie in both NP and co-NP and have no known polynomial-time solutions – providing a strong foundation in probabilistic modelling, computational complexity, and optimisation. Elena now leads collaborative initiatives to develop practical frameworks and implementation guidance for privacy-preserving methods, including differential privacy, federated learning and synthetic data generation. Her leadership centres on building cross-disciplinary resources that integrate statistical programming, machine learning (ML), artificial intelligence (AI) and large language models (LLMs) to enable compliant, scalable and scientifically robust use of real-world data (RWD). |
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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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Emerging Trends & Innovation |
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The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group, has published a new White Paper, Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry. This White Paper provides guidance for adopting cloud services in regulated life sciences. It explains how GxP requirements apply to cloud providers and offers a clear framework for planning and executing exit strategies to ensure data integrity, business continuity and compliance. |
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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. 09:00–11:30 (EDT) / 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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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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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 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. |