| The course runs from 23 to 27 March 2026. |
This intermediate-level course deepens students’ understanding of pharmacoepidemiological methods and how to apply real-world evidence in regulatory and safety decision-making. As the third in a series of courses that form the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance, this course explores methods for addressing confounding, evaluating study quality, and interpreting evidence across multiple data sources and study designs.
Students on this course will engage with real-world examples and simulated regulatory scenarios, from critical appraisal and meta-analysis to risk management planning and response to adverse drug events.
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.
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 who would like to be assessed in order to obtain a Professional Certificate can register for the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance, comprising this and two other courses.
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.
£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.
Applications for 2025 are now open and can be made via our online application form.
In your application, please:
- Describe your prior knowledge of or experience with epidemiological concepts (e.g., bias, confounding) and pharmacovigilance (e.g., risk management planning, signal detection)
- Explain your motivation for taking this course and how it fits into your professional development
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.