In this module, two of the most important issues within the drug development process and the whole of clinical research are addressed.
In addition to reviewing the general principles of medical ethics and how they apply to clinical research as defined within the various guidelines and statutes we will have presentations from patient groups and a member of an ethics committee. The issues around business ethics and marketing will also be explored.
We will look at the mechanisms of cellular toxicology, the value of spontaneous reporting and the use of large electronic data bases as means of evaluating the safety of medicines. We will look at safety issues from the point of view of the sponsor, the investigator and the regulator and learn how to develop and implement a risk management plan.
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