PHARMACOVIGILANCE AND ADVERSE EVENT REPORTING IN CLINICAL TRIALS: BEST PRACTICES

Abstract

Pharmacovigilance and adverse event (AE) reporting are critical components of clinical trials and the broader pharmaceutical industry. This abstract provides an overview of best practices in pharmacovigilance and AE reporting, emphasizing the importance of pre-trial preparation, rigorous data collection and assessment, meticulous reporting and documentation, proactive risk management, and the integration of advanced technology. Adherence to international standards and regulatory guidelines, including Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), is essential. These best practices ensure the ethical conduct of clinical trials and contribute to the safety and efficacy of pharmaceutical products.