Professional Regulatory Affairs

Program Overview

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. 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.