This course will extend the core module Law, Ethics and the Regulation of the Development and Use of Medicines, for example, by providing a comprehensive examination of the role of the international regulatory agencies such as those of the European Union and the United States and their influence on the Australian regulatory processes examined. Other aspects of the regulatory process mentioned briefly in the core module, such as issues relating to pharmaceutical chemistry, will be considered in more detail. However, the major emphasis of the module will be on case study and critical appraisal. Students will review registration dossiers, write evaluation reports and prepare Pre-ADEC responses. The focus of this work will be the optimization of the regulatory process. Students will also participate in a mock Australian Drug Evaluation Committee (ADEC) meeting to gain an understanding of that Committee's procedures and decision-making processes.