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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

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Prioritising for a data-driven 2023

European Pharmaceutical Review

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Artificial Intelligence and Machine Learning in Software as a Medical Device.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Christophe Vaessen. STeP participation does not imply product authorization.

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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Data governance and HIPAA rules around this are very clear—you can’t identify the individual. It’s a win-win-win for everyone.”.

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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Data governance and HIPAA rules around this are very clear—you can’t identify the individual. It’s a win-win-win for everyone.”

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New quality requirements for tobacco products

European Pharmaceutical Review

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. This resulted in certain manufacturers exiting the market. References Smoking, Drinking and Drug Use among Young People in England, 2021. Internet] NHS Digital. 01 February 2023.