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 (9 - 13 November 2026): 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 (1 - 5 February 2027): 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 (15-19 March 2027): 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.

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?

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)