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Experts to come together for compliance event ‘validation ready’ global labeling systems  

pharmaphorum

Experts to come together for compliance event . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

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The criticality of compliance

pharmaphorum

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.

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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceutical companies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations.

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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceutical companies. Environmental monitoring is another important aspect of Annex 1.

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Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

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How automatization keeps drug safety in war-torn Ukraine

pharmaphorum

Ukrainian pharmaceutical companies are struggling to perform their duties in pharmacovigilance as Russia launched a wide-scale war in Ukraine. Russia’s full-scale invasion of Ukraine has already affected the global pharmaceutical industry a lot. This platform made work easier for many pharmaceutical companies.

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Frontiers Health Steering Committee spotlight: Roberto Ascione

pharmaphorum

Roberto Ascione is the CEO of Healthware Group (pharmaphorum’s parent company) and a member of the Frontiers Health Steering Committee. He’s been involved with the event from the early days, and he says he sees different ways in which pharma could integrate digital therapeutics. What will the market dynamics of DtX look like?