Post Graduate Diploma in Pharmacovigilance Syllabus

Syllabus & Subjects of Post Graduate Diploma in Pharmacovigilance 

The Post Graduate Diploma in Pharmacovigilance curriculum is designed to equip students with a comprehensive understanding of the fundamental principles and practices governing drug safety. The program commences with an in-depth introduction to pharmacovigilance, encompassing its definition, historical development, and the core concepts and terminology that underpin the field. A pivotal component of the curriculum delves into the realm of adverse drug reactions (ADRs) and drug safety. This module elucidates the various types and classifications of ADRs, providing students with a robust foundation for recognizing and managing potential risks associated with pharmaceutical products. Additionally, emphasis is placed on the crucial process of ADR reporting and documentation, ensuring that students are adept at the meticulous record-keeping essential for regulatory compliance and patient safety. Causality assessment, another critical facet of pharmacovigilance, is thoroughly explored. This encompasses the systematic evaluation of the relationship between a drug and an adverse event, enabling students to discern the likelihood and strength of the connection. A nuanced understanding of causality assessment is imperative in discerning genuine safety concerns from coincidental occurrences, thereby informing critical decisions in drug development and post-market surveillance. Furthermore, signal detection and management form a crucial component of the curriculum. Students learn to discern signals of potential safety concerns from the vast pool of data generated through pharmacovigilance activities. They are equipped with methodologies for signal assessment, validation, and subsequent management, ensuring timely and appropriate responses to emerging safety issues.

Syllabus of Post Graduate Diploma in Pharmacovigilance