Therapeutic Product Development Process and Clinical Trials

Overview

This unit provides students with knowledge and skills in therapeutic product development to evaluate a products performance in prevention, treatment, diagnosis, and monitoring of the body for health purposes.

Unit learning outcomes

Students who successfully complete this unit will be able to:

1. Describe the use and development of medical devices for biomedical and other scientific measurements, including drug delivery
2. Investigate the similarities and differences in the regulatory environment involved in developing a commercial product, including pre- and post-marketing phases of a potential drug candidate and medical device candidates life cycle
3. Apply principles of research ethics and complete an internationally recognised Good Clinical Practice certificate for participant safety
4. Describe the reporting requirements for adverse events reporting in clinical trials, including those related to the use of an Investigational Medical Device, from unexpected physiological responses to device deficiencies – reliability, safety, performance
5. Differentiate the different kinds of medical devices and critically evaluate clinical trial protocols in the context of the medical device development process

Teaching methods

Hawthorn

Assessment

Content

• Concepts of biomedical instrumentation
• Drug & medical device development – regulatory bodies
• Calibration and standards
• Electrical safety
• Medical device lifecycle
• Clinical trial phases
• Human research ethics and Good Clinical Practice
• Similarities/Differences between pharmaceutical & medical device development
• Adverse event standards and reporting
• Graduate Attribute – Communication 1 - Verbal Communication 
• Graduate Attribute – Communication 2 - Communicating using different media 
• Graduate Attribute – Teamwork 1 - Collaboration and negotiation 
• Graduate Attribute – Teamwork 2 - Teamwork roles and processes 
• Graduate Attribute – Digital Literacies 1 - Information literacy