STAT
APRIL 9, 2025
Two decades ago, when I first began practicing emergency medicine, patient documentation was a manual process. Phones were not smart and the fax machine was still a cornerstone of communication in the department. I would write on carbon-copy forms that were later stored in the belly of the hospital, in archives, as patient files.
STAT
JUNE 27, 2025
And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators. This marks the second time in recent months that GSK has angered a lawmaker over the asthma inhaler switch. In March, U.S. Elizabeth Warren (D-Mass.)
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Express Pharma
DECEMBER 30, 2024
He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines. The panel also noted the importance of mock recalls to test readiness for real-life scenarios.
European Pharmaceutical Review
AUGUST 7, 2025
Successful collaboration therefore hinges on dynamic, well documented protocols for anonymisation, consent, role allocation, transparency and ongoing compliance, all balanced against the pace of AI driven innovation: Anonymisation versus technical utility: Only data that have been irreversibly anonymised fall outside GDPR scope.
Express Pharma
JUNE 20, 2025
Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.
Express Pharma
JANUARY 10, 2025
This requires clear communication with data principals about personal data usage and consent processes.” While the Act provides certain exemptions for research, these activities must adhere to specific standards to ensure lawful and secure data processing with purpose limitation.
Express Pharma
JULY 21, 2025
He noted frequent gaps in team understanding due to staff turnover and stressed the need for strong communication, confidentiality, and documentation practices. Emphasis was placed on treating contracts as living documents and aligning all operational actions with documented expectations.
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