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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: 20 September.
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Cloud Adoption in the Life Sciences Industry 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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Data Transparency: Call For Volunteers |
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The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project is extending its work and has a new opportunity to provide feedback on the ISRCTN Results System Prototype. This new registry is designed to align with World Health Organisation (WHO) data requirements and UK clinical trial regulations, making results submission easier, more flexible, and more accurate, while ensuring access and re-use of trial results. Background Information: ICRCTN recently released information for public review and comment regarding the new registry they are working on, and the results system prototype is open for review until the end of September. The key principles of this results system is to comply with the WHO data requirements and UK clinical trial regulations, making results submission as easy as we can and provide flexibility for different study designs. Also to help researchers submit accurate and complete data, along with ease of access to this information and re-using the results. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing Datedate: 24 September. |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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