Course Description
In-depth examination of the Latin American Biomedical Regulatory
landscape for obtaining marketing approval for drugs and
biologics in major markets, including an examination of early
medical product development, clinical trial phases, marketing,
and pharmacovigilance.
Athena Title
LA Biomedical Regulatory Scien
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
- Students will describe the chronological steps necessary to market a new drug in Latin American countries.
- Students will explain the Latin American regulatory structure and the agencies involved in filing a new medicinal product application.
- Students will explain the significance of the organizational structure of different regulatory agencies.
- Students will differentiate the approaches used to regulate different types of medicinal products.
- Students will compare pre-market approval decision-making and post-market compliance decision-making.
- Students will explain the principles and role of international pharmacovigilance.
- Students will describe the basic concepts of New Drug Applications and generic drug applications.
- Students will critically evaluate how regulatory agencies help protect the health and safety of people in Latin America.
- Students will describe the requirements and processes involved in granting a medicinal product marketing authorization in Latin America.
- Students will explain the legal obligations of the marketing authorization holder.
- Students will summarize the regulatory submission requirements for marketing authorizations in Latin America.
Topical Outline
- Industry organization
- Process for product development
- Product commercialization
- Drug discovery and chemical synthesis
- Quality assurance processes
- Regulatory affairs and sciences procedures, including manufacturing, design control, planning and implementing
clinical studies, product application, marketing, and post-marketing surveillance
