Pharmaceutical and Medical Device Development

Graduate Certificate in Medicine (Pharmaceutical and Medical Device Development)

Graduate Diploma in Medicine (Pharmaceutical and Medical Device Development)

Master of Medicine (Pharmaceutical and Medical Device Development)

Master of Medicine (Advanced)(Pharmaceutical and Medical Device Development)

Graduate Certificate in Science in Medicine (Pharmaceutical and Medical Device Development)

Graduate Diploma in Science in Medicine (Pharmaceutical and Medical Device Development)

Master of Science in Medicine (Pharmaceutical and Medical Device Development)

Master of Science in Medicine (Advanced)(Pharmaceutical and Medical Device Development)

Not available to student visa holders or to international students to study offshore. International students in Australia on other visas with study rights may apply.

Overview

The Pharmaceutical and Medical Device Development program meets the growing need for expertise in modern pharmaceutical and medical device development practices and provides training in state-of-the-art techniques, approaches and requirements for the development and registration of medical products. The coursework has been developed in consultation with a large advisory group comprising senior members of industry and regulation who contribute to the teaching.

The program is tailored to professionals working in the pharmaceutical, bio-pharmaceutical and medical device industry, regulatory affairs, drug product evaluation, registration and therapeutic marketing sectors. Students are introduced to modern approaches to drug and device design and development and provided with a set of skills essential for the current industry environment.

More specifically, students learn about the process of medicines and medical device development, manufacturing requirements, therapeutic guidelines, regulations, clinical trials, bioethics, registration and required documentation, post-registration follow-up, policies, economics and clinical epidemiology. Students have the chance to prepare and critically evaluate regulatory submissions and design ethical clinical trials within national and international guidelines. Students will also have the opportunity to learn current methods used in drug and device development, such as molecular therapies, novel-formulations, and personalised medicine. Concepts of pharmaco-economics, pharmaco-vigilance and pharmaco-epidemiology related to drug and device development are also considered.

A great benefit of the course will be interacting with people at a similar stage in their career, sharing knowledge and skills in a supportive environment, as well as making key contacts with leading experts in industry and regulatory bodies.

Course outcomes

The program has been designed to ensure that the knowledge you gain can be applied to current industry needs and be readily integrated into your day-to-day work. You will have the opportunity to learn the basic science underpinning innovative therapies, current pharmaceutical trends, regulatory processes, communication, decision-making, and the evidence and ethics relevant to the pharmaceutical industry. You will gain insights and understanding of the key steps involved in current medical technology processes needed to bring products to market.

Course Information

The program is designed and delivered by leading industry and regulatory professionals and academics. The flexible format of interactive online delivery is well suited to professionals whose continuing education is limited by time and distance.

Further enquiries

Professor Paul M Young
Phone: +61 2 9114 0350
Email: