Pharmaceutical Regulatory Affairs Diploma Program
Duration: 28 Weeks
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.
Diploma Program: Please directly contact AAPS for Registration and Payment.
Individual Certificate Courses: Please see below for online availability. The online courses are registered and paid for individually.
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