The aim of this course is to equip you with the understanding and techniques to generate high-quality evidence on the safety and effectiveness of medicines, while addressing common sources of error in studies using real-world data.

During this course, you will:

• Develop understanding of concepts, study designs, and methods in pharmacoepidemiology.
• Apply statistical techniques to generate real-world evidence using electronic health record data.
• Identify and address biases and other sources of error that can occur in studies using real-world data.

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?

• Measurements in pharmacoepidemiology, including reproducible codelist building.
• Sources of real-world data around the world.  
• Frameworks and tools for across the RWE study lifecycle.
• Target trial emulation framework, including specification and emulation.  
• Planning a study and identifying fit-for-purpose data.
• Sources of error, bias and confounding in pharmacoepidemiological studies.
  • Confounding by indication.
  • Selection bias including referral, self-selection, and prevalence-incidence bias.
  • Information bias including differential and non-differential misclassification, and immortal time bias.
  • Other biases specific to pharmacoepidemiology including protopathic bias, channeling, and depletion of susceptibles.
• Introduction to causal thinking and directed acyclic graphs.
• Propensity scores, including high-dimensional propensity scores.
• Self-controlled study designs.  
• Quantitative bias analysis.
• Handling missing data. 
• Data-enabled trials.  
• Critical appraisal of published studies throughout. 
• Emerging topics:
  • Open science and reproducibility
  • Tools for distributed network pharmacoepidemiological studies
  • Pharmacoepidemiology in the digital era
  • Pharmacoequity
  • AI in pharmacoepidemiology
  • Pharmacogenomics

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, computer-based practical sessions).

Computer-based practical sessions will use Stata software. Prior experience of Stata is not required; however, some statistical programming experience is strongly encouraged.

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.

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. A key feature of this course is its co-development with the Clinical Practice Research Database (CPRD) Research Team at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Students will also benefit from the insights of senior guest lecturers working at the forefront of pharmacoepidemiology and real-world evidence at academic and non-academic institutions around the world. These diverse perspectives ensure the course content is scientifically rigorous and relevant to real-world practice.

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.

Additional information

Course leaflet