SMIM22001U Pharmacovigilance: Signal detection and risk management
Master of Industrial Drug
Development (MIND) - elective
The course is preapproved as an elective in the
Master Medicines Regulatory
Affairs (MRA) programme. It is also open to
single course students who meet the admission criteria.
See course calender for course dates
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
After completing the course the student is 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
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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
On campus part:
Lectures, theory exercises including group work with real and simulated safety scenarios.
Self-study of course literature.
- Category
- Hours
- Lectures
- 20
- Preparation
- 88
- Theory exercises
- 15
- Exam
- 15
- Total
- 138
Application deadline is 8 weeks before the first day of
instruction.
Apply directly on the programme's
webpage
- Credit
- 5 ECTS
- Type of assessment
- Written assignment
- Type of assessment details
- The assignment has two parts:
1. A 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
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
Announced in the exam plan on the MIND homepage mind.ku.dk
- Re-exam
Announced in the exam plan on the MIND homepage mind.ku.dk
Criteria for exam assesment
To achieve grade 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
Course information
- Language
- English
- Course code
- SMIM22001U
- Credit
- 5 ECTS
- Level
- Part Time Master
- Placement
- Autumn
A 6 day course taken over a period of 3 weeks
- Schedule
- This is a blended learning course.
Online Part - 2 weeks duration but the workload is equivalent to one course day
On Campus Part - one week with workload equivalent to 5 course days
------
Combining two weeks of online learning, which is equivalent to one full course day and one week of on-campus/classroom-based learning.
See course calendar - Course capacity
- 25 participants
Price
Fees are published on the programme's homepage at https://mind.ku.dk/tuition/ Fee includes course materials and lunch/coffee. Prices may be subject to change.
Study board
- 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
- Morten Andersen (15-7173767869723265726869767769724477797268326f7932686f)
Lecturers
Morten Andersen
Maurizio Sessa
(professionals from safety/epidemiology/pharmacovigilance
departments in the pharmaceutical industry, regulatory agencies,
CROs to be selected)