Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices

This course provides a comprehensive introduction to regulatory affairs in the pharmaceutical and medical device industries, with a focus on global regulatory frameworks, compliance requirements, and the evolving regulatory environment.

Students will learn how to navigate the roles of key regulatory authorities, including the U.S.

Food and Drug Administration, and examine the complete product lifecycle from preclinical development and clinical trials to regulatory submission, approval, and post-market surveillance.

The curriculum covers regulatory strategy, compliance management, clinical trial oversight, interpretation of regulatory guidance, and the application of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.

Learners will gain practical skills in evaluating regulatory requirements, supporting compliance initiatives, managing documentation and oversight processes, and understanding emerging regulatory trends across the biotechnology, pharmaceutical, and healthcare industries.

This course prepares students for careers in regulatory affairs, clinical research, quality assurance, and medical device compliance.