TIPT Academic Programs

Pharmaceutical Regulatory Affairs

Program Modules

Foundation Module

The foundation module is designed to provide a general overview background in regulatory sciences such as the medical and biopharmaceutical concepts and introduce new concepts in pharmaceutical Regulatory Agencies, Regulatory Affairs, and Clinical Trials.

Core Module

This module provides training in pharmaceutical regulatory affairs including GMP, technical writing, documentation and project management required for a success career. Emphasis will be placed on IND/NDA/NDS/ANDA/BLA.

Advanced Module

Industry based projects mimicking regulatory affairs careers including the development of protocols and standard documentation requirements for the pharmaceutical industry.