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Data Transparency |
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The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data, such as risk of re-identification and invasion of privacy (balanced against maintaining data utility), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions. |
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Risk Based Quality Management | ||
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The Risk Based Quality Management Working Group have produced a survey on the topic of SDR/SDV in China. The goal of this survey is to gain insight into how companies across the industry are implementing SDR and SDV in sites in China. The output of the survey will be used to develop a reference document for informing future study approaches and/or adjusting current approaches to better align with global standards. The closing date for completing the survey: 30 September.
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Emerging Trends & Innovation – Calling for Feedback |
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The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group has produced a White Paper 'Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry'. This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 10 October |
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