This course is designed to orient students to the Drug Development Process, the clinical research, the clinical safety and pharmacovigilance functions within the corporate and regulatory context from Canadian and international perspectives and provides a comprehensive introduction to the clinical research process and its history and evolution. Development of drugs is used as a model. Students will learn about the responsibilities of the principal investigator, the sponsor, and the patient, in addition to the responsibilities of the review ethics board.
Upon completion, students should be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member. The student should also be able to describe the product approval process and discuss the general conduct of a typical clinical trial.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.