This course is only available to students currently enrolled in the Master of Medicine (Pharmaceutical & Medical Device Development) who meet the requirements for admission (see below).
The Pharmaceutical & Medical Device Development program has been developed to meet the growing need for expertise in modern drug development practices and provide training in state-of-the-art techniques, approaches and requirements for the registration of medical products.
The program is tailored to professionals working in the pharmaceutical and bio-pharmaceutical industry, regulatory affairs, drug product evaluation, registration and therapeutic marketing sectors. This program is designed to introduce students to modern approaches to drug and device design and development, providing an up-to-date set of skills essential for the current industry environment.
Students will learn current methods used in drug development, including: molecular therapies; novel-formulation; clinical trials design and analysis; and personalised medicine. Pharmaco-economic, pharmaco-vigilance and pharmaco-epidemiology related to drug development will also be taught.
The process of medicine and medical device registration encompassing therapeutic guidelines, regulation, documentation and post-registration follow up, and the range of drug technologies and medical devices that exist, their properties, classification, development and manufacturing requirements will be studied. Students will prepare and critically evaluate regulatory submissions, clinical trials and drug registration information.
The program is designed and delivered by leading industry and regulatory professionals and academics. For more information please visit the Sydney Medical School web site.