Program Description

The programme enables existing regulatory affairs personnel in the pharmaceutical regulatory industry to understand all current diagnostic and medical device regulations and develop the necessary skills to work successfully in the dynamic world of regulatory affairs. What subjects will I study?

• Lifecycle Management, Vigilance, Surveillance and Risk management
• Pharmaceutical Technology Regulatory Affairs
• Non Clinical and Clinical Evaluation of Pharmaceutical Technologies
• Principles of Discovery of Medicines and Development Planning
• Research Methods and Technical Report Writing
• Special Populations and Biologicals and Advanced Therapies
• Dissertation

Admission Requirements

• A second-class honours degree in science, engineering, quality, pharmaceutical or regulatory affairs or cognate areas. Those failing to meet the classification requirement may be eligible for entry to the Postgraduate Diploma.
• Candidates with significant experience in: pharmaceutical operations, quality engineering, device design, mid to senior management in industry, other professionals who wish to upskill in the regulatory affairs environment, regulatory affairs personnel themselves who want to upskill (as determined by the Institute’s recognition of prior learning policy), in addition to an honours primary degree in another discipline area may also be considered for entry.

IELTS Requirements

Listening	Reading	Writing	Speaking	Overall
6	6	6	6	6.5