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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 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. |
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 15:00-14:00 (GMT) / 8:00-9:00 (EST) / 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! "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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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 Process for Aggregate Assessment of Clinical Trial AE Data, a new project within the Safety Analytics Working Group, is calling for volunteers. The FDA’s 2021 draft update to the ‘Final Rule’ strongly supports aggregate assessment of clinical trial AE data, but provides little guidance on the best processes to use at different stages of development.
With a clear process that defines approaches to the differing challenges of AE assessment in early development compared with Phase III, the overall end-user experience for internal and external stakeholders would be improved.
When related preferred terms are grouped together, it would be beneficial to have a consistent process for analysis plan documentation, SDTM/ADaM specifications, and analysis displays.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 21 February.
The Kick-Off Meeting for this project will be held 25 February at 16:00-17:00 (GMT) / 11:00-12:00 (EST).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. The Kick-Off Meeting for this project will be held 6 March at 14:00-15:00 (GMT) / 9:00-10:00 (EST). |
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