Summary
This accredited course (ECTS 5), offered in collaboration with University of Copenhagen, covers principles of signal detection, signal management and risk management. We begin at the initial detection of potential signals in different data sources and continue 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. We cover the aspects of regulations, roles and responsibilities of the marketing authorisation holder, regulatory authorities, ethics committees, HCPs, and patients.
Teaching methods
- Online part: e-lessons that introduce you to the concepts of signal detection, signal management, and risk management.
- On location part: lectures and group work on real and simulated safety scenarios.
Keywords
- Data sources
- Methods for signal detection
- Signal management
- Risk management
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Course leader & lecturers
- Morten AndersenCourse leaderProfessor in Pharmacovigilance
University of Copenhagen - Wasim AnwarCourse leaderVice President & Deputy QPPV, Global Safety
Novo Nordisk A/S - Maurizio SessaLecturerAssistant Professor of Pharmacoepidemiology
Københavns Universitet
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Is this course for you?
This course is valuable for all experienced pharmacovigilance professionals, e.g. safety surveillance advisers, safety scientists, and patient safety associates.
What you will learn
- How to explain and describe data sources and methods for signal detection.
- How to describe relevant information flows, legislation and guidelines on signal management and risk management.
- How to explain key concepts related to signal management and risk management.
- How to explain and describe the roles and responsibilities of regulatory agencies and marketing authorisation holders.
What your company will get
- An employee who can independently integrate and evaluate safety information from various sources.
- An employee who can critically assess information and reflect on the appropriate actions to take.
- An employee who can develop a strategy for risk management.
- An employee who can plan risk minimisation activities and risk communication for different safety scenarios.
Course calendar
Online module
Intro webinar
13 November 2023
More details coming up
Day 1
Sources of data for signal detection
- Welcome, presentation of Course Leaders and participants
- Spontaneous reporting systems
- Safety reporting in clinical trials
- Other solicited data sources and external data bases
- Qualitative versus quantitative signal detection
- Disproportionality methods
- Workshop - Signal detection case example
Day 2
Regulatory requirement and Signal Management
- Summary day 1 & intro to day 2
- Module IX. Signal prioritisation, validation, and assessment and reporting Case from the industry
- Module IX .Signal prioritization, validation and reporting assessment
Case from the authorities - Quiz signal management
- Signal detection at WHO/authorities
- Advanced methods for signal detection
- Workshop - Case Signal Management
Day 3
Risk Management
- Summary day 2 & intro to day 3
- Definition of risk and risk management
- Development of the risk management plan
- Benefit-risk assessment
- Signals in big data
- Introduction to workshop through cases
- Workshop – Risk management examples
Day 4
Regulatory requirements for Risk Managements
- Summary day 3 & intro to day 4
- Risk managements plans GVP Module V
- Global requirements (ex EU)
- Quiz risk management
- Introduction to workshop
- Workshop
- QA session
Day 5
Risk minimizations / mitigation
- Summary day 4 & intro to day 5
- Risk communication
- Risk minimization strategies
- PASS and risk minimization
- Introduction to workshop through cases
- Assessing the effectiveness of risk minimization initiatives
- Wrap up and evaluation of the course
Registration
Registration deadline2 Oct 2023
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you get access to mandatory and optional readings via your personal Atrium log-in. Please familiarise yourself with the mandatory readings before starting the course. The mandatory readings are also part of the examination syllabus.
Readings include selected chapters from textbooks, including Mann’s Pharmacovigilance (current edition) as well as relevant legislation, including EU directives and regulations, good pharmacovigilance practice guidelines, scientific papers and review papers.
Prerequisites
Applicants must meet the following criteria:
- A relevant BA degree or equivalent
- A minimum of 2 years of relevant job experience
Examination
The exam is a written assignment and takes place digitally (the online exam platform of the University of Copenhagen).
Date: 22 December 2022
Course leaders
University of Copenhagen
Novo Nordisk A/S
Lecturers
Københavns Universitet
University of Copenhagen
Novo Nordisk A/S
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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