The purpose of this course is to introduce to students a number of health issues and their challenges. This course also introduced a number of national health programmes. The roles of the pharmacist in these contexts are also discussed.

This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products.

This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, the global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.