| The course runs from 10 November 2025 to 30 June 2026. |
The global health challenge of ensuring drug safety while maintaining public confidence has become increasingly complex. Pharmaceutical companies must employ dedicated pharmacovigilance professionals. NGOs need confidence that the medicines they supply are both effective and safe. Health authorities must deliver high-quality care while managing costs. Regulatory bodies must weigh the benefits of drugs against concerns about potential harms.
This intensive, modular course addresses the growing demand for professionals trained in assessing drug safety and evaluating the risks and benefits of drug use. As an introductory-level course, it is designed to meet the needs of a wide range of individuals. The diverse backgrounds and expertise of our lecturers ensure a strong balance of theoretical insight and practical applications.
This well-established training programme equips students with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the programme, you will be able to:
- Demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans. This includes the cause, manifestations, and consequences of adverse drug effects (ADEs), how these are detected and monitored, and the related historic and legal frameworks.
- Compare fundamental statistical, economic, and epidemiological concepts and methods.
- Understand and reflect upon important pharmacoepidemiological concepts and methods, and how these methods can be applied to specific drug issues and pharmaceutical risk management.
- Critically appraise the results of published pharmacoepidemiological studies, including a critical appraisal of the research question, study design, methods, statistical analyses, and interpretation.
Course structure
The course is organised into three blocks taught during the following weeks:
- Block 1 (10 - 14 November 2025): Introduction to Pharmacoepidemiology
By the end of Block 1, students should be able to:
- Describe the main study designs used in pharmacoepidemiology and understand their strengths and limitations.
- Demonstrate a basic understanding of the epidemiological and statistical theory underpinning the conduct, analysis, reporting, and interpretation of pharmacoepidemiological studies.
- Critically assess key components of published pharmacoepidemiological studies, including the research question, study design, methods, statistical analysis, and interpretation.
For more details, please visit the dedicated page for Block 1.
- Block 2 (2 - 6 February 2026): Introduction to Pharmacovigilance
By the end of Block 2, students should be able to:
- Appreciate and reflect critically upon the impact of regulatory frameworks on pharmacovigilance activities in the UK and internationally.
- Understand the role and limitations of spontaneous reporting in pharmacovigilance.
- Evaluate key principles of Health Technology Appraisal.
For more details, please visit the dedicated page for Block 2.
- Block 3 (23 - 27 March 2026): Intermediate Pharmacoepidemiology & Pharmacovigilance
By the end of Block 3, students should be able to:
- Understand confounding and interaction and their implications for study design and interpretation.
- Assess compliance of studies with STROBE/RECORD reporting standards.
- Understand key approaches to handling confounding, including multivariable regression, propensity scores, and case-only designs.
- Critically appraise meta-analyses and studies using multiple data sources or study designs.
- Apply pharmacoepidemiological evidence to regulatory decision making, risk management planning, and responses to adverse drug events.
For more details, please visit the dedicated page for Block 3.
What topics are covered?
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 concerns at individual and population levels, and practical applications of pharmacoepidemiological principles and methods.
Key course topics include:
- Pharmacoepidemiology - Students will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses, and limitations in determining the effects of medications in populations. The statistical basis underpinning pharmacoepidemiology will also be introduced. Students will integrate statistical and epidemiological concepts to gain competence in critically appraising pharmacoepidemiological studies.
- Pharmacovigilance - Students will be introduced to the core components of pharmacovigilance and its basis in drug regulation. The course will demonstrate how pharmacoepidemiology and pharmacovigilance work together in evaluating the safety of medicines, with reference to UK and international regulatory contexts.
- Health economics - Students will explore the key concepts of cost-effectiveness analysis and health-related quality of life measurement, with real-world case studies to illustrate core principles.
For a detailed list of topics covered in each block, please visit the dedicated pages for Block 1, Block 2 and Block 3.
Course delivery
All teaching will be delivered online and consists of:
- Self-study materials (e.g., pre-recorded lectures, Between-Block activities).
- Synchronous live sessions (e.g., Q&A, group discussions, practical sessions).
Each block is tentatively set to run 9:30-16:30 UK time daily, with morning and afternoon sessions spread over five days. This includes time to work through the self-study materials. Synchronous live sessions provide students the opportunity to apply and discuss concepts introduced in the self-study materials.
While attending all live sessions is not mandatory, students who attend tend to achieve the best results. Most lectures are pre-recorded and made available on the course website one week prior to each block. Some lectures are delivered live, and these are also recorded and uploaded to the course website within 24 hours. Live sessions (except for practicals) will be recorded and made available to students within 24 hours. Practicals will not be recorded; however, solution sets to all practicals are made available immediately following each practical to allow students to work through the materials in their own time. Students can access an online forum on the course website to post questions about any of the course materials to the course tutors during the course.
Teaching faculty
This programme is developed and delivered by a diverse team of world-leading researchers and educators at LSHTM, a global centre of excellence in public health, epidemiology, and health data science. In addition, students will benefit from the insights of senior guest lecturers working at the forefront of the pharmaceutical industry, regulatory bodies, and public health institutions around the world.
Our teaching faculty has made major contributions to the development and advancement of pharmacoepidemiology and pharmacovigilance both in the UK and internationally. They are actively engaged in applied research and policy development, ensuring the course reflects the latest scientific advances and regulatory developments. This mix of academic rigour and real-world insight ensures the course content is both intellectually robust and directly applicable to professional practice.
Assessment
To obtain the full Professional Certificate (30 Level 7 credits), students must:
- Complete all three blocks.
- Submit a 4000-word written Project critically appraising a potential drug safety signal (40% of the total grade).
- Take a 2-hour written Exam of short answer questions (60% of the total grade).
Students must pass both the Project and Exam to be awarded the Professional Certificate. Students may resit any failed component only once additional time.
There is no formal assessment for individual blocks. However, students who attend a majority of the live sessions and engage with the self-study materials may request a Certificate of Attendance.
Time commitment
Each block consists of ~28 hours of formal teaching and contact time. The full Professional Certificate pathway requires ~300 total hours:
- ~80 hours of formal teaching and contact time.
- ~120 hours of self-directed study.
- ~100 hours to complete the Project.
Flexible study options
Not ready to commit to the full course? Students can register for individual blocks without assessment. If desired, they may later upgrade to the full Professional Certificate pathway.
Students may complete the full Professional Certificate course within one academic year or spread it across two consecutive years.
Additional information
- Course leaflet
- Programme specifications
- Already familiar with the basics? See our follow-up course: Real-World Evidence in Pharmacoepidemiology (Block 4)
Are you an organisation interested in training your team?
We offer bespoke courses designed specifically for organisations wishing to train their teams in pharmacoepidemiology and pharmacovigilance. To date, we have delivered bespoke trainings, both in person and online, to teams from the pharmaceutical industry, regulatory and governmental bodies, and other academic institutions in the UK and abroad. Please contact us at shortcourses@lshtm.ac.uk for enquiries.
The programme
“An excellent course - engaging teaching and extremely well-organised. I learned a lot, and the online format was surprisingly interactive.”
“A great mix of theory and application. The balance between pre-recorded material and live discussion worked really well.”
“The lecturers were fantastic, experts in their field and very approachable during live Q&A.”
“The small peer groups created at the start of the course really helped me feel connected and supported throughout. I learned a lot from discussing assignments with others.”
“I now feel much more confident interpreting pharmacoepidemiology studies and understanding how regulatory decisions are made.”
"Some tough subjects dealt with in a very entertaining way, which made them easier to understand."
"All lecturers are very enthusiastic, interesting and knowledgeable. Makes the content fun and enjoyable."
“Considering that the course covered a wide range of material, the instructions for the project and exam were clear and manageable.”
Specific sessions
“The lecture on real-world data in different countries gave me a global view that I hadn’t appreciated before.”
“Brilliant explanation of meta-analysis. It’s the first time I’ve really understood how to critically assess one.”
“Case-only designs were new to me – this lecture made it click.”
“The risk management planning workshop was one of the most useful parts. It brought everything together.”
“The project prep sessions helped clarify how to synthesise different types of evidence. Very practical.”
£5,390 full fee
£3,305 for students or charity status
£1,885 for residents of LMICs (eligible countries)
When applying for discounted fees, please include proof of student or LMIC status instead of your CV. LMIC status can be confirmed with a passport and proof of current residence. Charity status refers to individuals who are currently affiliated with a charity.
This course is ideal for those involved in drug development, licensing, surveillance, research, real-world evidence, and policy within:
- The pharmaceutical industry
- Academic institutions
- NGOs
- Regulatory bodies
- Health services
- Policy-making agencies
Prerequisites for this course include:
- An undergraduate degree (e.g., bachelor's) in a subject appropriate to the course (e.g., epidemiology, statistics, pharmacy, biological sciences, chemistry, physics, medicine, dentistry, etc); or
- At least 6 months of relevant experience (requires pre-approval from the Programme Director; please contact the Short Course team before applying).
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 40 participants will be accepted.
Applications for 2025 are now open and can be made via our online application form.
The application deadline will be 23:59 (UK time) on Friday, 10 October 2025. We strongly advise that you apply early as courses may close earlier than the stated deadline if they become full.
In your application, please include a short personal statement explaining why you want to take this course and how it supports your professional development. Be sure to upload evidence that you meet the course prerequisites and English language requirements. Applications that do not include the required documentation will not be considered.
Please read LSHTM's Admissions policies prior to submitting your application.
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.