Certificate in Pharmacoepidemiology and Pharmacovigilance

Course Outline

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.

Attendance

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. 

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

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 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.

Accreditation

The course may be included as part of a Professional Development Plan.

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.

Who should apply for this course?

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 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.

Comments from Recent Students of this Course

The Course

• "Very informative with good workshops and high quality teaching"
• "Lecturers with extensive practical experience, will definitely recommend the course"
• "Really enjoyed the workshops with examples to work through - made it easier to learn"
• "Lecturers and workshops are of very high quality"
• "Overall atmosphere - a fun way to learn, with stimulating interactive sessions"
• "Some tough subjects dealt with in a very entertaining way which made them easier to understand"
• "Teaching quality - leaders in the industry!"
• "Thank you, I enjoyed it very much and learned a lot"
• "All lecturers are very enthusiastic, interesting and knowledgeable. Makes the content fun and enjoyable.

Specific Lectures

• "Thoroughly enjoyed this talk and could have listened to more. Especially liked the RMP proposals" (The EMEA and the EU risk management guideline)
• "Particularly enjoyed these lectures. I didn't think it was possible to put something so difficult in such simple terms. Content, pitch, speed and delivery were wonderful." ( Multivariable analysis and propensity scores)
• "Just like the Clinical Trials lecture, this was brilliant. Both these lecture have given me something that I'll have to practice during my work to try to become proficient" (Meta analysis of Randomized Trials)
• "First time I've got to grips with concept of meta analysis." (Critical appraisal of meta analysis
• "The workshop was brilliant! Great way to demonstrate the applications and explain the difficulties in this field of work" (Structured examination of a response to an ADR alert)
• "Excellent lecturer - topic not the easiest, but lecture kept lively with good examples. Good summary of the key message at the end" (Case only design and analysis)

Course Tutor Profile

Ian Douglas

The London School of Hygiene & Tropical Medicine is committed to improving global health through its programme of short and full-time postgraduate study.