CTMG6002 - Drug Development

This course is part of our Post-Degree Diploma in Clinical Trials Management.

How do drugs and medical devices go from lab to clinical use? What research is required to get them to patients and demonstrate safety and effectiveness along the way? This course allows students to gain knowledge and understanding of the drug development process, the regulatory framework and explore the differences between drugs and medical devices.

Topics

Legislation on the drug approval process
Phases of drug and medical device development
The pre-clinical and clinical activities required for drug approval
Clinical trial outputs - safety and efficacy data and interpretation

Diploma Program Progression

Successful completion of first term courses (Minimum 70% average with no single final grade below 65%) is required for progression to second term courses. Successful completion of first and second term courses is required for progression to practicum.