To fulfil our mission to share – contribute – advance, PHUSE has successfully built relationships with regulatory agencies, standards organisations and industry groups. We value these relationships and partnerships. Our collaborations have been strengthened through our events and Working Groups.
PHUSE collaborates with the FDA (Food & Drug Administration) on the Computational Science Symposium (CSS) in Maryland, USA and with Working Groups such as Data Transparency, Study Data Standardization Plan and the development of reviewer guide templates and examples.
We work with the EMA (European Medicines Agency) on the PHUSE Data Transparency CSS sessions. PHUSE is an official stakeholder in a number of EMA initiatives including data sharing policies, cloud computing and data standards.
Health Canada presents at the Data Transparency CSS sessions. PHUSE participated in the Reference Group for Public Release of Clinical Information Guidance.
The ASA (American Statistical Association) and the FDA work with PHUSE on the development of R-shiny applications for inclusion in marketing applications.
The PMDA (Japan Pharmaceuticals and Medical Devices Agency), FDA and CDISC all partner to provide answers to industry questions on SDTM and ADaM implementation.
PHUSE partners with CDISC in joint initiatives to develop implementation strategies and processes for CDISC standards in data submissions and on projects that advance industry education, like the CDISC Primer Project.
And many other valued projects and partnerships.
12-13 June: Japan Interchange, Tokyo
30-31 August: China Interchange, Shanghai
12-13 November: Korea Interchange, Daegu
23-24 October: US Interchange, Scottsdale
Global Compliance Portal: Country-Specific Requirements for Clinical Trials Disclosure – Joint Effort by PHUSE and Xogene
