Pharmacovigilance in no profit clinical research. Requirements and challenges
DOI:
https://doi.org/10.33393/ao.2024.3097Keywords:
Patient Safety Management, Pharmacovigilance process, Pharmacovigilance training, PV in no profit clinical research, Research TeamAbstract
The goals of Pharmacovigilance (PV) include early detection of new adverse reactions, broadening information on known reactions, identifying risk factors, comparing drug safety profiles, and effectively communicating safety information to healthcare professionals. In non-profit clinical research, PV activities often face challenges due to limited resources and training. An exploratory survey by the Italian Data Manager Group in 2022 highlighted critical issues in non-profit clinical trials, such as the lack of multidisciplinary support and insufficient training in PV. To strengthen PV in non-profit studies, continuous professional development and adequate resources are essential. Ensuring the presence of dedicated, well-trained professionals and promoting the use of updated tools and processes can significantly improve the management of PV activities, ultimately safeguarding patient health and maintaining high-quality research standards.
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Cagnazzo C., Cenna R., Stabile S. et al. Pharmacovigilance in no profit clinical trial: duties and responsibilities for the research team, P354 21st ISoP Annual Meeting 2022. DOI: https://doi.org/10.1007/s40264-022-01219-7 DOI: https://doi.org/10.1007/s40264-022-01219-7
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Copyright (c) 2024 Celeste Cagnazzo, Veronica Franchina
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Accepted 2024-06-18
Published 2024-08-01
