Pharmacovigilance: Signal detection and risk management
Course content
The course covers principles of signal detection, signal management and risk management. This starts from the initial detection of potential signals in different data sources and continues through the signal management process to signal validation and assessment of the benefit-risk balance. It further 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. Topics are:
- 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
Master of Industrial Drug Development (MIND) - elective
The course is preapproved as an elective in the
Master Medicines Regulatory Affairs
(MRA) programme.
Upon completion of the course, students are expected to be able to:
Knowledge
- 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 asessed
Skills
- 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
Competencies
- 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
Online part: e-lessons that will introduce you to the concepts
of signal detection, signal management and risk management. The
e-lessons are equivalent to one full course day but can be taken
over a period of one week.
On campus part:
Lectures, theory exercises including group work with real and
simulated safety scenarios.
Self-study of course literature.
Selected chapers from textbooks, including Mann’s Pharmacovigilance, current edition. Relevant legislation including EU directives and regulation, good pharmacovigilance practice guidelines, scientific papers and review papers.
A list of recommendations for reading and selected material will be accessible before the course together with web exercises. During the course further material for exercises, group work and case studies will be distributed.
Registered students register via the self-service
on KUnet.
New
students apply via this link:
Pharmacovigilance: Signal Detection and Risk Management –
University of Copenhagen
- ECTS
- 5 ECTS
- Type of assessment
-
Home assignment
- Type of assessment details
- The assignment has two parts:
1. A set case study that is presented with a short description and/or a scientific publication. The student is expected to identify key information, analyse the case study, critically assess data, methods and results, by answering a series of questions.
2. Short questions covering different topics of the course. - Aid
- All aids allowed
Read more about the GAI-rules: Generative AI and good academic practice in UCPH's education programmes – University of Copenhagen
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
-
See exam schedule.
- Re-exam
-
Same as ordinary.
Criteria for exam assessment
To achieve a grade of 12, the student must be able to:
Knowledge
- 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 asessed
Skills
- 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
Competencies
- 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
Part time Master courses
- Category
- Hours
- Lectures
- 20
- Preparation
- 88
- Theory exercises
- 15
- Exam
- 15
- English
- 138
Kursusinformation
- Language
- English
- Course number
- SMIM22001U
- ECTS
- 5 ECTS
- Programme level
- Part Time Master
- Placement
- Autumn
A 6 day course taken over a period of 2 weeks
- Price
-
Fees are published on the course webpage at Pharmacovigilance: Signal Detection and Risk Management – University of Copenhagen.
- Schedulegroup
-
This is a blended learning course.
Online Part - 1 week duration but the workload is equivalent to one course day
On Campus Part - one week with workload equivalent to 5 course days
-----
Combining one week of online learning, which is equivalent to one full course day and one week of on-campus/classroom-based learning.
See course calendar - Capacity
- 25 participants
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Drug Design and Pharmacology
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Maurizio Sessa
(14-506478756c7d6c723176687676644376787167316e7831676e)
Main Course Responsible - Morten Andersen
(15-7173767869723265726869767769724477797268326f7932686f)
Co Course Responsible
Teacher
Maurizio Sessa - Course Responsible
Morten Andersen - Co Course Responsible
(professionals from safety/epidemiology/pharmacovigilance
departments in the pharmaceutical industry, regulatory agencies,
CROs to be selected)
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Kursusinformation for indskrevne studerende