The global health challenge of maximising drug safety yet maintaining public confidence has become increasingly complex. Pharmaceutical companies are required to employ named members of staff responsible for pharmacovigilance. Health authorities grapple with the need to provide quality care whilst containing a burgeoning drug budget. Regulatory authorities must balance the potential benefits of new drugs with varying levels of suspicion of their potential harm.
This 20-week examined course in pharmacoepidemiology and pharmacovigilance addresses the increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. It is an introductory course and should meet the needs of a wide variety of practitioners.
The course will help participants acquire a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. Specifically, it will:
The course is aimed at personnel concerned with the safe use of medicines, particularly in developed countries, including those working (or intending to work) in:
The course may be included as part of a Professional Development Plan.
The course is part-time and comprises 230 hours (approximately one day per week on average) which are spent as follows: 80 hours formal teaching and contact time, 80 hours self-directed study and 70 hours project work. Participants will be allocated a personal academic advisor, who will give them guidance in writing their project.
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 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 course.
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.
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.
Course Organiser: Ian Douglas
Course Co-organiser: Sinead Langan
Applicants will normally have a science, biomedical or biostatistical background, hold a second class honours degree of a United Kingdom university (or equivalent) in a science, medical, statistical or related subject and will have some experience in the area. However, previous experience will be taken into account in all cases.
Applicants must have a good standard of written and spoken English, and of English comprehension. In certain cases the School may ask the applicant to provide evidence of a satisfactory standard of English.
A Curriculum Vitae should be submitted with the application.
*Payable by: 9 October 2015
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