This capstone unit develops the critical thinking needed to transform a new therapeutic drug 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 work in groups to determine the submission strategy and assign individual components where each student solves a clinical/scientific question related to one core aspect of the process (i.e. manufacturing, stability, clinical trial or other suitable component of the process). The group will meet at the face to face workshop to compile the dossier before presenting tho their peers and industry experts.
discussion forums and webinars plus compulsory face to face workshop.
group dossier submission strategy (20%), individual submissions (40%), participation in discussion boards and webinars (20%) and group presentation at workshop (20%)
Online readings and other learning resources will be provided
CEPI5100 and 18 credit points of stream specific units of study