London School of Hygiene & Tropical Medicine

Students will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognising these general principles apply more broadly throughout the world.

The overall module aim is to equip students with a thorough understanding of the concepts and practice of pharmacovigilance.

Intended learning outcomes

Upon successful completion of the module a student will be able to:

1. Demonstrate an understanding of the legislation and regulations for pharmacovigilance and pharmacoepidemiology activities in the UK and internationally.
2. Gain a thorough understanding and reflect critically upon the role of spontaneous reporting in pharmacovigilance. 
3. Critically apply understanding the key principles of Health Technology Appraisal.
4. Apply pharmacoepidemiology evidence to decision making, risk management planning and responses to adverse drug events.

Assessment

There is one assessed component. The exam will consist of a critical appraisal of a peer reviewed paper and multiple short answer questions (SAQs), covering the following 4 topics: 

• Adverse drug reactions & risk/benefit.
• Health economics.
• Risk management and minimisation.
• Spontaneous reporting, disproportionality.

Mode of delivery

Our distance learning modules are delivered entirely online via directed self-study and online materials via the Virtual Learning Environment.

Module duration

Distance learning module studies begin at the start of October each year. Students may start their studies at any time once they gain access to Moodle (the virtual learning environment) and study materials, and work through the materials in line with the assessment schedules. The study year runs from the beginning of October through to June examinations. Some students also study between June and September with extended tutorial support (e.g. those undertaking projects, the Clinical Trials integrating report, or two of the Epidemiology modules). Deadlines for submission of coursework vary per programme but are usually in February, March, May, and September.

How you'll study

Our distance learning programmes are predominantly online and largely self-directed study to enable you to study independently and at times convenient to you. You'll have access to tutorial support and the ability to interact with other students and form study groups throughout the study year via the discussions in our Virtual Learning Environment, Moodle.

Credits

• CATS: 15
• ECTS: 7.5

Module specification

For full information regarding this module please see the module specification.

Please note: information based on the 2025-26 module specification subject to change for 2026-27 entry.