| The course runs from 15 to 19 March 2027. |
As real-world evidence becomes increasingly central to regulatory and safety decision-making, this course builds on foundational knowledge to develop deeper expertise in pharmacoepidemiological methods. Students will learn common approaches to identify and address confounding and bias; appraise evidence across study designs and data sources; and apply insights to regulatory processes. Through real-world case studies and simulated safety scenarios, the course equips students to critically evaluate and apply evidence in complex decision-making environments.
This course can be taken as a standalone course or as the third in a series of courses that form the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance.
The aim of this course is to equip students with a greater understanding of intermediate concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the course, 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.
Why study with us?
We are global leaders in training the next generation of experts in drug safety and effectiveness. Since 1998, our courses in pharmacoepidemiology and pharmacovigilance have helped students and professionals worldwide build the skills and confidence to evaluate medicines using real-world data, critically appraise evidence, and contribute to regulatory and clinical decision-making. With alumni in over 50 countries, our training supports career growth across the pharmaceutical industry, government agencies, and academia.
Our courses are developed and delivered by the EHR Research Group, a team internationally recognised for its work in pharmacoepidemiology and the use of large-scale health data to improve patient care and policy. We work closely with experts from regulatory bodies, universities, and industry to ensure our teaching is practical, current, and globally relevant. Whether you are new to the field, advancing your career, or preparing for your next step, you will gain practical skills and knowledge that open doors to a wide range of opportunities in pharmacoepidemiology and pharmacovigilance.
What topics are covered?
- Review of confounding and interaction.
- Multivariable analysis, including logistic regression and survival analysis.
- Propensity scores and case-only study designs.
- Use of negative control analysis.
- Reporting standards (e.g., STROBE, RECORD, RECORD-PE).
- Critical appraisal of systematic reviews and meta-analyses.
- Opportunities and challenges of using electronic health record databases for signal detection.
- Use of electronic health records in pharmacoepidemiology and pharmacovigilance.
- Coding of drug exposures and outcomes in real-world data.
- Practical issues in designing and interpreting pharmacoepidemiological studies.
- Pharmacoepidemiology as a tool for risk management planning.
- Approaches to synthesise evidence across studies.
- Simulated workshops on risk management planning and drug safety alerts.
Course delivery
All teaching will be delivered online and consists of:
- Self-study materials (e.g., pre-recorded lectures).
- Synchronous live sessions (e.g., Q&A, group discussions, practical sessions).
The course 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 will get the most out of the course. Most lectures are pre-recorded and made available on the course website a week before the course starts. 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.
Assessment
There is no formal assessment. However, students who attend a majority of the live sessions and engage with the self-study materials may request a Certificate of Attendance.
Students seeking formal assessment and certification can register for the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance.
Teaching faculty
This course 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 pharmacoepidemiology and pharmacovigilance in industry, regulatory bodies, and public health institutions around the world.
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 [email protected] for enquiries.
£1,630 full fee
£1,000 for students or charity status
£570 for residents of LMIC (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 individuals concerned with the safe and effective use of medicines who should apply, especially those working in:
- The pharmaceutical industry (e.g., drug development, licensing, surveillance)
- Regulatory authorities (e.g., medicines licensing, monitoring)
- Academic and research settings (e.g., drug effectiveness and safety evaluation)
- Health services (e.g., drug policy, decision-making)
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)
This course builds upon the topics covered in Introduction to Pharmacoepidemiology (Block 1) and Introduction to Pharmacovigilance (Block 2). Prospective students should provide clear evidence of their knowledge and/or experience with the topics covered in Block 1 and Block 2 in their application to this course.
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.
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. Visit our bespoke courses website for full details and how to get in touch.
Applying for this course
Applications for 2027 are now open and can be made via our online application form.
The application deadline will be 23:59 (UK time) on 15th February 2027. 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. You should also describe your prior knowledge of, or experience with, key epidemiological concepts (e.g., bias, confounding) and pharmacovigilance topics (e.g., risk management planning, signal detection). 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.