Clinical Trials and Regulatory Affairs

Module code: BMD378

Credits: 15.0
Semester: SEM2
Timetable:

Seminar
• Semester 2: Weeks 11: Wednesday 9 am - 12 pm
• Semester 2: Weeks 9: Thursday 2 pm - 5 pm

Tutorial
• Semester 2: Weeks 3: Thursday 11 am - 1 pm

Lecture
• Semester 2: Weeks 1, 2, 6, 8: Thursday 11 am - 1 pm
• Semester 2: Weeks 10, 11: Thursday 11 am - 1 pm
• Semester 2: Weeks 16: Friday 10 am - 12 pm
• Semester 2: Weeks 3: Thursday 9 am - 11 am
• Semester 2: Weeks 4, 5, 9, 12: Thursday 11 am - 1 pm

Workshop
• Semester 2: Weeks 5: Thursday 2 pm - 5 pm

Contact: Miss Livia Carvalho
Overlap: None
Prerequisite: None

This module will introduce students to the whole spectrum of the clinical trials process from first-time-in-human-beings studies through to post-marketing studies that examine whether clinical trial promises translate to 'real-life' benefits for patients, with reliable evidence that benefits are likely to exceed their harms. The stringent processes for establishing and appraising the evidence with be critically discussed, together exploring the issues of the global market-place for medicines, the roles and challenges of regulators responsible for approving new drugs for public.

Connected course(s): UDF DATA
Assessment: 80.0% Examination, 20.0% Coursework
Level: 6