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Pharmacovigilance: Signal detection and risk management
Acquire an understanding of the principles of signal detection, signal management and risk management.
This course is a part of
Learn about the data sources and methods for signal detection, and the process of signal management, including signal prioritisation, validation and assessment.
Increase your knowledge of risk management activities and benefit-risk assessment, the related regulatory processes and the responsibilities of the marketing authorisation holder.
Through this course, you will be provided with a comprehensive overview of signal detection and risk management from the initial detection of potential signals in different data sources and continuing through the signal management process to signal validation and assessment of the benefit-risk balance.
The course also deals with risk management, risk minimisation activities and risk communication. Included are regulations, roles and responsibilities of the marketing authorization holder, regulatory authorities, ethics committees, healthcare professionals and patients.
The course is tailored for both academia and industry.
Course topics
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
Course director and lectures on Pharmacovigilance: Signal detection and risk management
Course details of Pharmacovigilance: Signal detection and risk management
Dates and examination
Course dates
Online pre-course (1 day's workload):
16-20 September 2024
Campus part:
30 September-4 October 2024
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
Learning outcomes
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.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information in the admission criteria on Master of Industrial Drug Development.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as an elective course in the Master of Industrial Drug Development and Master of Medicines Regulatory Affairs. Priority is given to students already enrolled in either of the two programmes. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens: 30,000 DKK
Non-EU/EEA citizens: 33,475 DKK
Early Bird: Register by 27 March 2024 and save DKK 3,000 on the price above.
The fee includes lunch/coffee.
Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66