Professional Certificate in Pharmacoepidemiology & Pharmacovigilance

Course Content

The curriculum will provide an introduction to epidemiology, statistics, pharmacoepidemiology and health economics. It will also cover the historical and legal background to pharmacovigilance and pharmacoepidemiology, and pharmacological basis of ADEs, addressing ADE issues at individual and population levels, and the application of pharmacoepidemiological principles and methods to practical drug issues.

Teaching Methods

Teaching will include traditional lectures and seminar/workshops during formal teaching, self-directed learning in between formal teaching and self-directed (but supervised) project work. Workshops will address topics such as designing a pharmacoepidemiological study, critical appraisal of published papers, developing risk management plans and responding to a drug safety alert. The self-directed component will be facilitated by the provision of detailed course material. Students will be provided with a reading list pertinent to the training.
The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety. The teachers range from academic staff at the School, with expertise in areas such as pharmacology, epidemiology and statistics, to senior practitioners in the international pharmaceutical industry, regulatory authorities, and public health who have practical expertise in pharmacovigilance and pharmacoepidemiology.

Methods of assessment

The course is examined through unseen written examinations and submission of a written project, the subject of which is determined by the course organiser. All materials for the project will be provided, and each student will be supported by an academic adviser. Additionally two lectures on the chosen topic will be included in the syllabus.