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Lecture topics will include: bioethics in relation to scientific research and drug development; a survey of the biopharmaceutical development processes; the production of generic biopharmaceuticals; the regulatory issues facing the introduction of pharmaceuticals; the design and management of clinical trials. The module will also involve a site visit to a biopharmaceutical company, based in Ireland and an associated report on the processes observed. Workshops on clinical trials and regulatory affairs will support the lecture material and involve written assignments.
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