Pharmacovigilance Course

The focused course ends with a practical knowledge of drug safety science and risk management techniques. In this course, pharmacoepidemiology, signal detection, and adverse event monitoring and regulatory reporting are among the subjects. The students will gain hands-on experience with international reporting standards such as FDA, EMA, and CDSCO; safety databases; case processing; and causality assessment. Risk minimisation plan design, benefit-risk analysis, and risk communication are all part of his core components. The major practical exposure is guaranteed through a capstone project or internship at a pharmaceutical company or a contract research organisation. Other topics included inspection readiness and safety surveillance planning, and literature surveillance. It can also be seen that legal and ethical frameworks of drug safety will be examined. After finishing, students will be able to oversee safety teams, create pharmacovigilance systems, and guarantee regulatory compliance. Graduates are thus prepared to take up positions in clinical trial safety supervision, medical information, and drug safety monitoring. This course improves project management, regulatory, and analytical skills.