| The course runs from 2 to 6 February 2026. |
The safe use of medicines relies on robust systems of surveillance, critical evaluation, and transparent regulation. Pharmacovigilance plays a central role in monitoring and responding to emerging safety issues throughout a medicine’s life cycle. As the second in a series of courses that form the Professional Certificate in Pharmacoepidemiology & Pharmacovigilance, this course provides a comprehensive introduction to key pharmacovigilance concepts and systems in the UK, EU, and globally.
Students on this course will examine the evolving role of real-world data, risk management planning, and health technology appraisal in assessing the benefits and risks of medicines and vaccines. A major strength of this course is its international perspective, with case studies and contributions from global regulatory and public health authorities.
The aim of this course is to equip students with a basic understanding of the concepts and practice of pharmacovigilance in the UK and internationally. By the end of the course, 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.
What topics are covered?
- NICE appraisal of new and current health technologies.
- Spontaneous reporting systems and pharmacovigilance from the regulatory authority perspective.
- Guidelines on pharmacoepidemiology & pharmacovigilance: the role of CIOMS, ICH, ISPE, MedDRA.
- Risk management guidelines and planning.
- Statistical methods of signal detection.
- Impact analysis of drug safety signals.
- Case studies in health technology appraisal.
- Regulations for medicines in special populations, including pregnancy.
- Continuous evaluation of risk-benefit balance.
- Decision-making under uncertainty and rapid-cycle analysis.
- Assessing health-related quality of life.
- Vaccine pharmacovigilance.
- Pharmacovigilance in resource-limited settings.
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 the pharmaceutical 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).
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 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.