Professional Certificate (30 credits)
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. NGOs need to have confidence that the medicines and products that they provide to communities are both effective and safe. 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 30-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 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.
Starting from the 2019/2020 intake, as well as including core epidemiology topics and sessions on global and UK pharmacovigilance, the course will include a number of additional dedicated Focus on Europe sessions. These will be led by renowned experts in EU pharmacovigilance and pharmacoepidemiology, and will ensure that the content of the course remains of utmost relevance to those working in the EU.
The course is part-time and comprises 300 hours (approximately one day per week on average) which are spent as follows: 80 hours formal teaching and contact time, 120 hours self-directed study and 100 hours project work.
For those wanting to complete the course but who are unable to attend in person, there is a distance learning version of this course available. This includes the option of following a blended learning approach, where students sign up for the distance learning course but are able to attend Block 1 of the London-based course. Click here for more information on distance and blended learning options
This course has been approved by the Federation of the Royal Colleges of Physicians of the UK for 30 Category 1 (external) Continuing Professional Development (CPD) credits.
Who should apply for this course?
The course covers aspects of drug development, licensing, surveillance and policy, and is aimed at personnel who are working (or intending to work) on any of these aspects in the following sectors:
- the pharmaceutical industry
- regulatory bodies
- health services
- health policy decision-making agencies
Brexit and advice for EU nationals
Whatever the outcome of the ongoing Brexit process, students from the EU are very welcome at LSHTM and we would strongly encourage applications from EU nationals to this course.
Links to related LSHTM advice:
Aims & Objectives
The aim of this well established training programme is to equip students with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the programme, students should be able to:
- demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner of which these are detected and monitored, and the related historic and legal frameworks
- be familiar with and compare fundamental statistical, economic and epidemiological concepts and methods
- gain an understanding of, and reflect upon, important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues and pharmaceutical risk management
- assess and critically analyse the results of pharmacoepidemiological studies (other investigators'), including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation
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 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.
"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.
"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)
Graduates from this programme enter a diverse range of positions.
Below you will find just a few of the positions and organisations that our graduates from this course have entered:
- Example job titles:
Clinical Trials Project Manager
Manager (Drug Safety and Public Health)
Risk Management Manager
Therapeutic Group Co-Ordinator
Associate Manager in Drug Safety
- Example organisations:
Department of Health
Gilead Sciences, Inc.
Medicines and Healthcare Products Regulatory
University of Oxford
Medicines and Healthcare Products Regulatory Agency (MHRA)
The student is responsible for obtaining any visa or other permissions to attend the course, and is encouraged to start the application process as early as possible as obtaining a visa for the UK can sometimes take a long time. The Short Courses team can provide supporting documentation if requested.
Accommodation and meals
A list of hotels located in the vicinity of LSHTM, along with further resources for short term accommodation, can be found on our accommodation pages. Tea and coffee vouchers will be provided during breaks.
Evening meals are not catered for at LSHTM, however there is a large choice of restaurants, cafés and shops nearby.
- If you have been offered a place on the course you will not be able to register without bringing formal ID (Passport) and without having obtained the correct visa if required.
- It is essential that you read the current visa requirements for short course students.
- LSHTM may cancel courses two weeks before the first day of the course if numbers prove insufficient. In those circumstances, course fees will be refunded.
- LSHTM cannot accept responsibility for accommodation, travel and other losses incurred as a result of the course being cancelled.