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 intensive modular 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 individuals. 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.
Course delivery
The course is organised into the following three Blocks, with the teaching for each Block delivered synchronously online during the following weeks:
- Block 1 (13 - 17 November 2023): Introduction to Pharmacoepidemiology
- Block 2 (5 - 9 February 2024): Introduction to Pharmacovigilance
- Block 3 (25 - 29 March 2024): Intermediate Pharmacoepidemiology & Pharmacovigilance
Students can sign up for one, two, or three Blocks. Students who would like to be assessed in order to obtain a Professional Certificate (30 credits) must attend all three Blocks in addition to preparing a project (submitted in April/May) and taking an exam (in May/June).
Each Block consists of approximately 27 hours of formal teaching and contact time (via online synchronous teaching/group work). The full assessed course leading to a Professional Certificate (three Blocks plus project and exam) comprises 300 total hours, which are spent as follows: ~80 hours formal teaching and contact time, ~120 hours self-directed study, and ~100 hours project work.
Already know the basics? Our Real-World Evidence in Pharmacoepidemiology short course (Block 4) provides hands-on experience analysing and overcoming common sources of error when using real-world data.
Who should apply for this course?
This introductory level course covers aspects of drug development, licensing, surveillance and policy, and is aimed at individuals who are working (or intending to work) on any of these aspects in the following sectors:
- the pharmaceutical industry
- NGOs
- regulatory bodies
- health services
- health policy decision-making agencies
There are no formal prerequisites for this course, but some experience equivalent to the followed is required:
- an undergraduate degree (e.g., bachelor) in a subject appropriate to the course (e.g., epidemiology, statistics, pharmacy, biological sciences, chemistry, physics, medicine, dentistry, etc.); or
- in exceptional circumstances requiring pre-approval from the course organisers, at least 6 months’ relevant work experience
As part of the application process, applicants are required to demonstrate how they meet the LSHTM’s minimum English language requirements. This course requires Band B or above, or Band C with extensive recent experience in an English-speaking setting. For more information, please refer to the LSHTM English Language Requirement Policy.
If you do not satisfy the above requirements you may still be admitted at our discretion on the basis of your academic qualifications, work experience and references.
Up to 25 participants will be accepted for each Block.
Advice for EU nationals
Students from the EU are very welcome at LSHTM and we would strongly encourage applications from EU nationals to this course.
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
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.
Key Course Topics
Pharmacoepidemiology - you will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. The statistical basis underpinning pharmacoepidemiology will also be introduced, and you will integrate statistics and epidemiology to gain competence in critically appraising pharmacoepidemiology studies.
Pharmacovigilance - you will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognizing these general principles apply more broadly throughout the world.
Health economics - you will be introduced to the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Real-world examples will be used to illustrate concepts.
Teaching Methods
This is an online course. There is no face-to-face component of this course.
Teaching will be delivered primarily via online synchronous sessions during each Block. The course is tentatively set to run 9:00-17:00 local UK time daily during each teaching Block. This will include pre-recorded lectures from subject matter experts. Students and tutors will then interact in live Q&A sessions and workshops where students have the opportunity to apply and discuss concepts introduced in the pre-recorded content. 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. In addition to the pre-recorded lectures, students will be provided with lists of helpful scientific papers, articles and other content to assist with learning. Live Q&A sessions will be recorded and made available to students. Practicals will not be recorded.
For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), there will also be self-directed learning in between the online synchronous teaching weeks in the form of completing a project and practice exams.
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.
Assessment
For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), the assessment consists of submission of a written project (worth 40% of the total grade) and a written examination (worth 60% of the total grade). You must be awarded a pass grade on both components to be awarded the Professional Certificate.
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 for the project will be included in the syllabus.
There is no formal assessment at the conclusion of each individual Block, but a Certificate of Attendance will be provided.
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)
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:
-
Attending Pharmacist
Clinical Trials Project Manager
Manager (Drug Safety and Public Health)
Pharmacist
Risk Management Manager
Scientific Assessor
Therapeutic Group Co-Ordinator
Associate Manager in Drug Safety
Consultant Physician
Medical Assessor - Example organisations:
-
Baxter
Canadian Forces
Department of Health
Gilead Sciences, Inc.
GSK (GlaxoSmithKline)
IDIS
Medicines and Healthcare Products Regulatory
Quintiles
University of Oxford
NHS
Medicines and Healthcare Products Regulatory Agency (MHRA)
Applying for the course
- Full course (all Blocks including Exam and Project)
Application deadline 13 October 2023
- Block 1 (13 - 17 November 2023): Introduction to Pharmacoepidemiology
Application deadline 13 October 2023
- Block 2 (5 - 9 February 2024): Introduction to Pharmacovigilance
Application deadline 5 January 2024
- Block 3 (25 - 29 March 2023): Intermediate Pharmacoepidemiology & Pharmacovigilance
Application deadline 25 February 2024
Please read LSHTM's Admissions policies prior to submitting your application.