Course Title: Biotechnology: Regulation and Business Law

Part A: Course Overview

Course Title: Biotechnology: Regulation and Business Law

Credit Points: 12.00

Course Code




Learning Mode

Teaching Period(s)


City Campus


135H Applied Sciences


Sem 2 2006,
Sem 2 2007,
Sem 2 2009,
Sem 1 2011

Course Coordinator: Assoc. Prof. Gina Nicoletti

Course Coordinator Phone: +61 3 9925 2133

Course Coordinator Email:

Pre-requisite Courses and Assumed Knowledge and Capabilities

Nil prerequisites.  Students will be postgraduate students with developed learning and research skills.

Course Description

This course presents regulatory and legal aspects of management relevant to organisations involved in the biotechnology industry. The course introduces the student to relevant quality systems and the complex regulatory, legal and ethical environment operating at the local, national and international level that governs the conduct of biotechnology organisations. It will also address professional and societal ethical constraints of relevance to biotechnology.

Objectives/Learning Outcomes/Capability Development

Students will develop a capability for independent research, identification of relevant information resources, critical analysis of relevant data and information, evaluation of options and the making of recommendations.  Students will be able to
• identify issues arising from regulation and law in product development and commercialisation
• appreciate the significance of regulation and relevant laws in the function, development and growth of an organisation
• apply their knowledge in the workplace



On completion of this course students will be able to operate at the management interface of the biotechnology industry and the many organisations that regulate its conduct. They will have knowledge of, and appreciate the significance of
• the role of quality systems in management, research and production
• the major codes, regulations and laws, local and international, governing the conduct of research and business organisations in biotechnology
• the legal environment significant in biotechnology and the legal liabilities to which it gives rise
• ethics and public concerns about the nature and impact of biotechnology on health and the environment
• professional conduct in biological research

Overview of Learning Activities

The course will use lecture, seminar and team-based learning modes
Students attend a formal program of lectures and tutorials and self-organised group workshops.

Overview of Learning Resources

Students will be referred to a variety of information sources such as organisation web-sites, government publications, agency and organisation published information, journal articles, news reports

Overview of Assessment

Assessment will be by individual and or group project work and/or oral defence of a report. Project topics will be based on current issues and problems in the course context.  Projects will be set but with scope for self-directed topic selection relevant to employment or special interests.