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.
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
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:
