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Real World Evidence – Calling For Feedback |
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The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 1 May 2026. |
Data Transparency – Calling For Feedback |
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The EU CTR Implementation Project within the Data Transparency Working Group has finalised the White Paper ‘Protecting Commercially Confidential Information (CCI) While Complying with the European Union Clinical Trials Regulation 536/2014’. This White Paper offers clear, practical guidance to help clinical trial sponsors navigate the EU Clinical Trials Regulation while safeguarding commercially confidential information (CCI). Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 6 May 2026. |
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