Course description
The Course
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 training 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 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.
Aims of the Course
The course will help participants acquire a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. Specifically, it will:
- enable participants to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner in which these are detected and monitored, and the related historic and legal frameworks
- introduce participants to fundamental statistical, economic and epidemiological concepts and methods
- introduce participants to important pharmacoepidemiological concepts and methods and to enable them to apply these methods to drug issues
- equip participants with skills to facilitate further learning in these areas
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 pharmaceutical industry who are involved in drug development, licensing, and surveillance
- regulatory bodies who are involved in licensing and surveillance
- the health service who are involved in drug policy, and
- health policy decision-making agencies
Entrance requirements
Applicants will normally have a science, biomedical or biostatistical background, hold a second class honours degree of a UK 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.