Global Certificate in Adverse Drug Reaction Analysis

• Introduction to Adverse Drug Reactions (ADRs): Understanding the basics of ADRs, their types, and significance in pharmacovigilance. • Pharmacodynamics and Pharmacokinetics: Exploring how drugs interact with the body, their absorption, distribution, metabolism, and excretion. • ADR Reporting Systems: Examining global ADR reporting systems, such as the FDA Adverse Event Reporting System (FAERS) and the WHO Programme for International Drug Monitoring (PIDM). • Causality Assessment: Learning methods for determining the relationship between a drug and an adverse event, including the Naranjo algorithm and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system. • Signal Detection and Management: Understanding the process of identifying and evaluating potential safety signals in ADR data. • Data Mining and Analysis Techniques: Employing statistical and machine learning techniques for ADR data analysis. • Regulatory Guidelines and Compliance: Reviewing international regulations and guidelines for ADR reporting, monitoring, and analysis. • Risk Management Plans: Designing and implementing risk management strategies to minimize ADRs and ensure patient safety.