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Pharmaceutical Regulatory
Affairs Diploma
The pharmaceutical, biotechnology, and medical device
research and development industries are among the most
regulated in the world.
AAPS regulatory affairs program provides a comprehensive
background and training required of regulatory affairs
professionals to address domestic and international
regulatory statutes and laws.
The AAPS Regulatory Affairs program includes courses
on; International, Health Canada, and FDA's laws, regulations,
and Guidelines, investigational and marketing applications,
technical writing, negotiation skills, development of
New Drug Application (NDA) submissions, labeling and
drug Information, Common Technical Documents (CTD),
Notice of Compliance (NOC), Good Clinical Practices
(GCPs), requirements for ongoing post-marketing surveillance
and post-marketing changes, communication and management
skills essential for the successful regulatory affairs
professional in an industry work environment.
AAPS graduates from Regulatory Affairs program can
pursue careers in the areas of Regulatory Affairs and
Quality Operations in pharmaceutical, biotechnological
and allied industries. Graduates will find employment
as Regulatory Affairs Associates, Regulatory Affairs
Assistants, Quality Assurance Associates, Quality Assurance
Investigators, Documentation Administrators and Medical
Information Associates.
Careers
Regulatory affairs (RA) is a dynamic and challenging
profession that is vital to making safe and effective
healthcare products available worldwide. RA encompasses
a variety of disciplines and job responsibilities, which
may begin during the product development and continue
into when a product is widely available for use.
RA professionals are employed in industry, government
and academia and are involved with a wide range of products,
including:
- pharmaceuticals
- medical devices
- in vitro diagnostics
- biologics and biotechnology
- nutritional products
- cosmetics and
- veterinary products
| Post –Graduate Diploma
in Professional Regulatory Affairs |
| |
|
| Introduction
to Pharmaceutical, Biological/Biotechnology, Natural
Health Products and Medicines |
| Introduction
to International Food and Drug Laws, Regulations
and Guidelines |
| New
Drug Development |
| Introduction
to Good Manufacturing Practices – Level I |
| Introduction
to Pharmaceutical Manufacturing |
| Good
Manufacturing Practices – Level II |
| Regulatory
Submission |
| Preclinical
–Drug |
| Intellectual
Property |
| Clinical
- Drug |
| Post
Approval Activities and Compliance |
| Formularies
and Reimbursement |
| Technical
Writing and Scientific Communication |
| Chemistry
Manufacturing and Control |
| Labeling
and Product Summaries |
| Global
Regulatory Strategies |
| Introduction
to Clinical Studies |
| Good
Manufacturing Practices – Level III |
| Generics
Drug |
| Natural
Health Products |
| Biologics/Biotechnology
Products |
| Medical
Devices |
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