The Pharmaceutical Regulatory Affairs Essentials course provides foundational knowledge of the regulatory framework governing the development, approval, and monitoring of pharmaceutical products. It focuses on regulatory compliance, documentation, and quality standards required to ensure the safety, efficacy, and quality of medicines. This course aligns with Terraleap’s mission to deliver industry-relevant education that bridges healthcare science and regulatory practice.

This course covers key aspects of pharmaceutical regulatory affairs, including drug development pathways, regulatory submissions, clinical trial regulations, quality and compliance requirements, labeling, pharmacovigilance basics, and post-marketing surveillance. It introduces global regulatory perspectives and the role of regulatory authorities in healthcare.

By the end of this course, learners will be able to:

• Understand the role of regulatory affairs in the pharmaceutical industry

• Identify key regulatory requirements for drug development and approval

• Explain basic regulatory documentation and submission processes

• Recognize quality, safety, and compliance standards

• Appreciate the importance of regulatory oversight in patient safety

After completing the course, learners will be able to:

• Demonstrate foundational knowledge of pharmaceutical regulatory affairs

• Support compliance-related activities in pharmaceutical settings

• Understand regulatory pathways and approval processes

• Apply regulatory concepts in academic or professional contexts

• Communicate basic regulatory requirements effectively

This course is suitable for:

• Pharmacists and pharmacy technicians

• Life sciences and biotechnology students

• Pharmaceutical industry professionals

• MedTech and healthcare compliance personnel

• Individuals seeking introductory knowledge in regulatory affairs