Enroll into AAPS’ PRA Post-Graduate Diploma Program
AAPS’ Professional Regulatory Affairs Post-Graduate Diploma Program provides a comprehensive background and training required of regulatory affairs professionals to address domestic and international regulatory statutes and laws.
Regulatory Affairs is a dynamic, constantly changing and very challenging profession that is absolutely essential in making sure safe and effective healthcare products are available worldwide. Regulatory Affairs covers a wide variety of disciplines and job responsibilities, many of which may begin during the product development and even continue on to when a product is widely available for use.
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, Electronic Common Technical Documents (eCTD), 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.
- 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
- Generic Drugs
- Natural Health Products
- Biologics/Biotechnology Products
- Medical Devices
Graduates of the Professional Regulatory Affairs Post-Graduate Diploma Program may work for pharmaceutical, biotechnological, medical device or natural health product companies. Trained and qualified RA professionals are in demand for pharmaceutical, biotech, medical device and natural health product companies as they are needed to navigate the intricacies of regulatory submissions for new products.
RA professionals are employed in industry, government and academia and are involved with a wide range of products, including:
- Document Control
- Regulatory Affairs Associate
- Regulatory Affairs Assistant
- Project Coordinator
- QA Associate
- QA Assistant
- Manufacturing Auditor
- Quality Auditor
Organizations who have hired AAPS Graduates
Choose a flexible online program that fits your needs. Fill out the form for more details!