Current course offerings

Please Note: Course profiles marked as not available may still be in development.

Course description

In this course students will learn about process of medical device development, manufacturing of drugs under strict GMP conditions, as well as regulatory and governance aspects of the two. Medical device development is an increasing area of clinical research and development in Australia, and globally. Students will learn in detail about methods of device manufacturing, and cutting-edge advanced techniques for developing and fabrication of medical devices, including 3D printing. They will learn about the guidelines that govern good practices in the R&D of medical devices. They will learn about the guidelines that govern good practice in manufacturing of devices and drugs. This will extend into description of upscaling processes for small batches required for pre-clinical proof-of-concept studies through to large batches required for clinical trials. They will learn about the various types of packaging for different medical devices and medicines and this will be aligned to regulations set by the Therapeutic Goods Administration (TGA) of Australia. They will learn about the various labelling requirements on the global stage and innovative labelling and packaging practices. Exposure to the regulation of therapeutic goods in Australia, how it compares to those overseas and why we have regulators along with the principles of research governance is a feature of this course.

Archived offerings