This course provides a general overview of the ethical issues and laws relevant to the development and marketing of medicines. It includes the following topics. State and Commonwealth Constitutional powers. Common law, statutory law, accountability, natural justice. Laws relating to the development and sale of medicines; patents, intellectual property, trade practices. Ethical issues in drug development and marketing. Preparation and submission of marketing applications, approval and appeal processes. Principles of Good Clinical Research Practice (GCRP). The ethical review process, consent procedures in biomedical research. The philosophy of regulation of drug use: input of industry, Government, consumer. The regulatory principles regarding the use of developmental drugs in human subjects and the practical consequences of these on the design and conduct of clinical investigations. The organization of the regulatory processes in Australia: The Therapeutic Goods Administration and advisory bodies (ADEC, ADRAC, etc.) The Pharmaceutical Benefits Advisory Committee. Submissions regarding cost effectiveness. Preparation and submission of an application for approval to test or marker a drug and the relevant appeal process. Integration of regulatory affairs into the pre- and post-marketing planning and review of product development strategies. Input from international bodies and national agencies.

Note: The course is compulsory for programmes 7370, 5504, and 9060.