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.

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?

• 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 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 the pharmaceutical 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.