Pharmaceutical Regulatory Affairs Certificate

AAPS’ Regulatory Affairs Certificate Program focuses on introducing the basic requirements for regulatory affairs professionals applicable to the Canadian, U.S. and international pharmaceutical, cosmetic and food industries.

Apart from an overview of the regulatory affairs terms, basic principles and regulatory pathways for product licensures, students will dive into the Good Manufacturing Practices (GMP) and learn how these standards contribute to the manufacturing of safe, effective and regulation compliant pharmaceuticals. This online certificate will also cover the Chemistry, Manufacturing and Control (CMC) requirements for both the product substance and drug product in accordance with the ICH guidelines. Students will also get a deep understanding of preclinical and clinical submissions, such as Clinical Trial Applications (CTA), New Drug Submissions (NDS), and Abbreviated New Drug Submissions (ANDS), they will get some hands-on training on the Common Technical Document (CTD) format, as well as labelling and product summary requirements, including Product Monographs, Package Inserts and Summaries of Product Characteristics.

The program focuses on topics delivered through four modules: 

• Introduction to Regulatory Affairs
• Good Manufacturing Practices Level I
• Pharma Regulatory Submissions, Labeling and Product Summaries
• Regulatory Affairs for Clinical Research and Preclinical – Drugs
• Chemistry, Manufacturing and Control