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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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End-to-End RBQM Education – Make the Most Out of Innovation and Ensure it’s Done Right!
Join the webinar to learn why change is not only an idea but a necessity. We will explore where old habits need to be retired and where new initiatives have proven to increase efficiency and reduce cost without impacting on quality.
This Webinar will be taking place virtually on 20 February at 15:00-14RWE Community Forum |
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RWD for Regulatory Decision-Making: Learnings from Use Cases and Demonstration Projects FDA guidance is clear that real world data (RWD) may be acceptable for regulatory approval when a randomised controlled trial is not feasible and the validity and trustworthiness of the real world study results are clearly demonstrated. To provide more operationalised guidance for meeting these standards, the presenters will share learnings from FDA use cases and ongoing demonstration projects. This Community Forum will be taking place virtually on 28 January at 14:00-15:00 (GMT) / |
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15:00 (CET)
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Data Transparency Winter Event 2025 | ||
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 Autumn Event will take place from 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 will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes.
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Responsible AI in a Healthcare System | ||
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Responsible AI in a Healthcare SystemAs the use of artificial intelligence (AI) moves from being a curiosity to a necessity, it is clear that the benefit obtained from using AI models to prioritise care interventions is an interplay of the model’s performance, the capacity to intervene, and the benefit/harm profile of the intervention. After a brief review of the kinds of use cases that AI can serve across multiple medical specialties, we will discuss Stanford Healthcare’s efforts to shape the adoption of health AI tools to be useful, reliable and fair so that they lead to cost-effective solutions that meet healthcare’s needs. We will conclude with the rationale and vision for collaborative activities such as the Coalition for Health AI. We will discuss how the adoption of LLMs in medicine needs to be shaped by performing the evaluations that specify the desired benefits and verify those benefits via testing in real-world deployments. The conversation will draw on examples from multiple specialties including pathology, cardiology, internal medicine, surgery, psychiatry and oncology. In this forum we will be joined by Dr Nigam Shah! Dr Nigam Shahhas been Chief Data Scientist at Stanford Healthcare since 2022. He leads artificial intelligence and data science efforts for advancing the scientific understanding of disease, improving the practice of clinical medicine and orchestrating the delivery of healthcare. His research group analyses multiple types of health data (EHR, claims, wearables, weblogs and patient blogs) to answer clinical questions, generate insights and build predictive models for the learning health system. This Community Forum will be taking place virtually on 18 February at 16:00-17:30 (GMT) / 11:00-12:30 (EST) / 17:00-18:30 (CET)
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RWE Community Forum
RWD for Regulatory Decision-Making: Learnings from Use Cases and Demonstration Projects
FDA guidance is clear that real world data (RWD) may be acceptable for regulatory approval when a randomised controlled trial is not feasible and the validity and trustworthiness of the real world study results are clearly demonstrated. To provide more operationalised guidance for meeting these standards, the presenters will share learnings from FDA use cases and ongoing demonstration projects.
This Community Forum will be taking place virtually on 28 January at 14:00-15End-to-End RBQM Education – Make the Most Out of Innovation and Ensure it’s Done Right! |
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Join the webinar to learn why change is not only an idea but a necessity. We will explore where old habits need to be retired and where new initiatives have proven to increase efficiency and reduce cost without impacting on quality. This Webinar will be taking place virtually on 20 February at 15:00-14:00 (GMT) / |
8:00- |
9:00 ( |
EST) / |
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Data Transparency Winter Event 2025
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 Autumn Event will take place from 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 will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes.14:00-15:00 (CET)
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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! Taking place 9–10 April, this innovative event will bring the PHUSE Community together to explore the transformative potential of real world data (RWD). Call for speakers is open, so wherever you are in the world, you can join us virtually – and for free – to share insights, learn and collaborate with like-minded individuals. Find out more about the event /wiki/spaces/WEL/pages/64290817. Look out for registration opening on 17 February! Here’s your chance to take the virtual stage and share your expertise! We’re looking for speakers to inspire, inform and lead the conversation on RWD. To guide your submission, here are some focus areas that will be central to the event:
Do you have a unique perspective that doesn’t fit into these categories? We encourage you to think outside the box and propose ideas that reflect the cutting edge of RWD. Submit your 150-word abstract by 22 January.
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Announcement - Emerging Trends and Technologies Working Group Has Changed its Name! |
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There’s been an exciting change in PHUSE 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.” PHUSE is 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: https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26804666/Emerging+Trends+Innovation Would you like to get involved in Working Groups? Check out the new Advance Hub page to view all opportunities: https://advance.hub.phuse.global/wiki/spaces/WEL/pages/67993601/Project+Volunteer+Board |
Working Group Quarterly Report |
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We have just published the last Working Group Report for 2024! You can view the Quarter 4 summary here, including the project reports and some of the highlights across our Working Groups for this final quarter. Don’t forget to check out the Working Group Events Report too, which provides a breakdown of the data collected from the Working Group Events for 2024. Well done to all our Working Groups who have had a fantastic 2024! |
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