PHUSE CUIDEACHTA FAOI THEORAINN RATHAIOCHTA
Budget
€10 — €0
EP Access
0
accredited persons
Staff
30
3 FTE
EU Grants
None
Mission & Goals
PHUSE is a global non-profit organisation dedicated to promoting the use of informatics & data science within the pharmaceutical & biotechnology industries. With global reach, we focus on facilitating collaboration among professionals, providing a platform for knowledge-sharing and innovation, & fostering the development of new tools to address challenges within clinical research for the ultimate benefit of human healthcare. Our organisation, with 12,000 community members around the world, organises numerous events, conferences, & working groups, enabling companies, regulators, & other stakeholders to stay updated on latest industry trends and best practice. PHUSE is the world’s largest community of clinical data scientists. We operate globally but mainly across Europe, America, Asia & the Far East. Run by volunteers with no commercial objective, our aim is to provide a platform for those working in clinical data to share best practice, facilitate innovation and discuss issues.
EU Legislative Interests
* European Strategy for Data: - EU Data Act - EU Data Governance Act – Regulation (EU) 2022/868 - GDPR / EUDPR – Regulation (EU) 2018/1725 * Interoperable Europe * EU Interoperability Act * European Strategy for Data * European Health Data Space * European Medicines Agencies Network Strategy * Data Quality Framework for EU Medicines Regulation * European Medicines Regulatory Network Data Standardisation Strategy * Pharmaceutical Strategy for Europe * Health Technology Assessment – Regulation (EU) 2021/2282 * Directorate-General Health Emergency Preparedness and Response (DG HERA) * EU pharmaceutical legislation for human medicines - EU variation regulation for human medicines (Regulation (EU) 1234/2008) * AI Act * EU Clinical Trials Regulation 536/2014 * Clinical Data Publication – Policy 0070
Communication Activities
* Keynote speakers at European PHUSE CSS 2025 - The EMA Transparency Department's Journey: The Perspective of a Regulator (Anne-Sophie Henry-Eude) - Embracing Data Analytics in the Medicine's Lifecycle (Frank Pétavy) - ICH M11: A Critical Enabler for Clinical Trial Transformation (Noémie Manent) - Developments in RWE Generation for Regulatory Decision Making (Daniel Morales) - Trustworthy AI for Tomorrow's Medicines (Luis Pinheiro) * Session Presenters at European CSS 2025 (Optimizing the Use of Data Standards, Data Transparency, Nonclinical Topics, Real World Evidence, Data Visualisation and Open Source Technologies Working Groups) * Panelist at PHUSE US Connect 2025 - EMA-CHMP Clinical Study Data Submission Pilot (Eftychia Eirini Psarelli) * Keynote speakers at FDA/PHUSE CSS - 2024 - Data Submission in Europe – An EMA Update (Eftychia Eirini Psarelli) - 2023 - Update on Transparency Aspects of the Raw Data Pilot and CTIS Guidance (Anne-Sophie Henry-Eude) * Session Presenters at FDA/PHUSE Data Transparency Working Group - Anne-Sophie Henry-Eude (annually for 5+ years) * Keynote Speaker at PHUSE EU Connect 2024 - Collectively Working Together in Research on Data Sharing: Regulator’s Perspective (Noémie Manent) * PHUSE responses of EMA Policy 0070 * De-identification Standard for SDTM 3.2 Version 1.0 * European Medicines Regulatory Network Data Standardisation Strategy Response
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
* Clinical Data Interchange Standards Consortium (CDISC) * US Food & Drug Administration (FDA) – via a Public-Private Partnership (PPP) or consortium agreement * American Statistical Association (ASA) * Clinical Research Data Sharing Alliance (CRDSA) * HL7 * PSI – (and through PSI, EFSPI)
Organisation Members
PHUSE is a free to join community of individuals with current over 12,000 members.
Additional Information
PHUSE accounts are a public record: https://find-and-update.company-information.service.gov.uk/company/05422297/filing-history
Connected Legislation
Commissioner Meetings
No recorded meetings with EU commissioners.