Causality Assessment in Pharmacovigilance Causality assessment is a critical process in pharmacovigilance, used to determine the relationship between a suspected adverse drug reaction (ADR) and a medicinal product. Accurate causality assessment is essential for...
Understanding the Coding of Adverse Drug Reactions (ADRs) in MedDRA Adverse Drug Reactions (ADRs) are unintended, harmful effects caused by the administration of pharmaceutical drugs. Monitoring and documenting these reactions is a critical component of...
Differences Between ADR (Adverse Drug Reaction) and ADE (Adverse Drug Event) In pharmacovigilance and clinical practice, understanding the distinction between Adverse Drug Reactions (ADRs) and Adverse Drug Events (ADEs) is essential for patient safety and effective...