MedCity News
FEBRUARY 6, 2024
The manual data population of site folders and electronic trial master files (eTMFs), for example, is time-consuming and poses issues, including limited document security and data privacy, archiving and retrieval difficulties and human error, resulting in up to a 25% failure rate.
Nixon Gwilt Law
APRIL 22, 2024
If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Implementation of risk management practices for all predictive DSIs, ensuring their validity, reliability, safety, security, and effectiveness.
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European Pharmaceutical Review
MARCH 12, 2024
If data used to support the safety , efficacy and quality of pharmaceutical products is compromised or unreliable, it can lead to regulatory non-compliance, product recalls, and most importantly, harm to patients who depend on those medications. Training and education. How can this be mitigated? Good documentation practices.
European Pharmaceutical Review
JULY 20, 2022
Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.
European Pharmaceutical Review
DECEMBER 14, 2023
Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve.
pharmaphorum
DECEMBER 22, 2022
For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance. Chapman, J.
PM360
NOVEMBER 12, 2023
New entrants come into a therapeutic class, often with increased efficacy or safety, while older products lose patent exclusivity, changing the promotional landscape. Nowadays, many physician and patient interactions are virtual, and, even when they are face to face, physicians usually rely on an electronic medical records (EMR) system.
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