This capstone unit develops the critical thinking needed to transform a new therapeutic drug and/or device into a commercially viable product. Students will critically appraise scientific and clinical data and information in order to prepare a final scientific dossier that would be suitable for submission to the TGA, EMA or FDA. Students will determine the submission strategy and solve clinical/scientific issues related to core aspects of the process (i.e. chemistry, manufacturing, stability, safety, clinical trial or other suitable component of the process).
online discussion forums, webinars
presentation of dossier submission strategy (20%), dossier submissions (50%), participation in discussion boards and webinars (20%) and reflective assessment (10%)
Online readings and other learning resources will be provided
CEPI5100 and 18 credit points of stream specific units of study