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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
The course covers principles of signal detection, signal management and risk management.
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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
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Signal management
- Regulatory processes, roles and responsibilities
- Signal prioritisation, validation and assessment
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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
For more details about the course, please refer to the course curriculum.
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Course director and lectures on »Pharmacovigilance: Signal Detection and Risk Management«
Course etails for »Pharmacovigilance: Signal Detection and Risk Management«
Dates and examination
Course dates
The next course is not yet scheduled. Exact dates will follow.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
After completion of the course, you will be able to:
- explain data sources, detection methods, relevant legislation, guidelines, and the key concepts of signal and risk management
- describe the information flow, processes, and roles of regulatory agencies and marketing authorisation holders in safety management
- analyse signal detection results, evaluate risk minimisation measures, and discuss actions and decisions in benefit-risk contexts
- develop strategies for risk management, including planning and communicating risk minimisation activities for various safety scenarios
- critically assess safety information, integrate data from multiple sources, and reflect on appropriate actions to address safety concerns.
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.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens
30,000 DKK
Non-EU/EEA citizens
33,475 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel.: +45 35 33 60 66