Pharmaceutical Regulatory Science
This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, drug products in regulated countries like US, EU, Japan, Australia and Canada.
It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products in regulated countries.
People who completed this course module in regulatory affairs can negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market.
