All Data quality articles
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PodcastsRegRapPod − April 2024
Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.
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EditorialImproving outcomes with data
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Data, the focus topic for this month’s journal, brings together a range of articles which are underpinned by one uniting factor: our absolute dependence on it. Perhaps, ...
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FocusHow data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.
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FocusData governance as a strategic imperative for regulatory compliance
Data governance is a multi-faceted arrangement that relies on data quality, data integrity, data and document management, security and safe storage. It is critically important to companies and regulators as they evaluate product quality, the manufacturing process and the reliability of study data from non-clinical and clinical research. The integrity ...