SMIM22001U Pharmacovigilance: Signal detection and risk management

Volume 2022/2023
Education

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

 

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
Learning Outcome

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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
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 2 weeks.
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
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
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