Čes. slov. farm. 2024, 73(3):E13-E22 | DOI: 10.36290/csf.2024.033
Enhancing pharmacovigilance practices: Insights from audits and ethical connotations
- Department of Philosophy, Doctoral Study Program of Applied Ethics, Faculty of Humanities, Charles University, Prague
Pharmacovigilance, pivotal in ensuring drug safety and regulatory compliance, requires meticulous surveillance and adherence to ethical standards. This article explores the multifaceted realm of pharmacovigilance, emphasizing the essential role of pharmacovigilance audits and compliance monitoring. By delving into key areas such as drug safety surveillance, signal detection, literature monitoring, and ethical considerations, this research sheds light on critical aspects of pharmacovigilance activities. The paper examines the outcomes of pharmacovigilance audits, highlighting common findings and areas for improvement to enhance regulatory compliance and the safety of pharmaceutical products. Insights gleaned from real-world experiences and regulatory guidelines underscore the importance of fostering a culture of good practice and ethical conduct in pharmacovigilance activities. By addressing challenges and trends, and elucidating the critical interaction between regulatory compliance, signal detection, and ethical considerations, this article provides valuable insights for stakeholders in the pharmaceutical industry, aiding them in optimizing pharmacovigilance systems and safeguarding patient safety.
Keywords: drug safety surveillance, ethical considerations, good practice, literature monitoring, pharmacovigilance, pharmacovigilance audits, regulatory compliance, signal detection
Accepted: September 23, 2024; Published: October 8, 2024 Show citation
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