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PREREQUISITE:
Minimum Bachelor's degree or three-year college diploma in
biological science,
health science, pharmacy, biotechnology, or bioengineering.
PROGRAM DURATION:
Approx. 28 Weeks
Schedule:
Monday – Thursday: 9:00am – 3:30pm, Friday: 9:00am – 2:00pm |
The program entails an intensive series of
learning modules developed to enable a practical
understanding of the regulatory approval and
communication processes involving pharmaceutical
and biotechnology drugs as well as natural
health products and medical devices. While
the primary emphasis is on regulatory affairs
as it applies in North America under the Canadian
Health Products and Food Branch (HPFB) and
the US Food and Drugs Administration (FDA),
the regulations in other major jurisdictions
such as Europe, Japan and Australia will also
be covered.
Students also acquire knowledge of international
health care system, health care legislation,
procedures and practices for regulating the
development, manufacture, quality assurance
and marketing of health care products. Our
hands-on approach provides the opportunity
for students to apply and integrate their
knowledge in a "real-world" work
setting under TIPT's IPE system.
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.
Written, oral and
practical examinations are mandatory at the
end of the foundation and core modules. In
the advanced module, assessment is based on
dissertation and viva-voce. In addition, the
overall grade is also based on continuous
assessments encompassing GMP and GLP compliance,
pharmaceutical documentation skills and interim
quizzes.
A diploma in Pharmaceutical Regulatory Affairs
is awarded upon successful completion of all
three modules.
Graduates of this program
are qualified for a career as:
Regulatory Affairs
Associate
Regulatory Affairs Specialist
Regulatory Affairs Officer
Technical Writer
Documentation Specialist
