Pharmacovigilance: Signal detection and risk management

The course covers the following themes:

Data sources and methods for signal detection

• Non-clinical data and data from clinical trials
• Spontaneous reporting systems
• Healthcare databases, drug/disease registries and electronic healthcare records
• Published literature and social media
• Disproportionality methods
• Epidemiological methods
• Data mining and text mining
• Artificial intelligence and machine learning

Signal management

• Regulatory processes, roles and responsibilities
• Signal prioritisation, validation and assessment

Risk management

• Regulatory processes, roles and responsibilities
• Benefit-risk assessment
• Potential and identified important risks
• Risk minimisation measures
• Risk communication
• Assessing the effectiveness of risk minimisation

After completion of the course, you will be able to:

• explain and describe data sources and methods for signal detection
• describe relevant legislation and guidelines on signal management and risk management 
• explain key concepts related to signal management and risk management
• explain and describe the information flow and regulatory processes involved
• explain and describe the roles and responsibilities of regulatory agencies and marketing authorisation holders
• explain how the effectiveness of risk minimisation measures can be assessed
• analyse the results of signal detection procedures
• discuss the limitations of data sources and methods
• analyse and discuss safety information in the context of benefit-risk assessment
• discuss the actions and decisions related to safety concerns
• discuss risk management and risk minimisation activities relevant in different safety contexts
• independently integrate and evaluate safety information from different sources
• critically assess information and reflect on the appropriate actions to take
• independently develop a strategy for risk management
• independently plan risk minimisation activities and risk communication for different safety scenarios

Participants must meet the following criteria

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience
• Be proficient in English

Find detailed information about the admission criteria.

Course responsible
Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Lecturers
Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.
Maurizio Sessa, Assistant professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Other guest lecturers
Professionals from safety / epidemiology / pharmacovigilance departments in the pharmaceutical industry and
regulatory agencies.

This course is offered as an elective course in Master of Industrial Drug Development and Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Industrial Drug Development or Master of Medicines Regulatory Affairs.

Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.