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 five day 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 - Claudia Pierleoni-NielsenLecturerDirector, Head of Safety Surveillance, Global Safety
LEO Pharma A/S - Atheline Major-PedersenLecturerSafety Surveillance Principal Specialist, Global Safety
Novo Nordisk A/S - Alicia Toft-HansenLecturerSafety Surveillance Specialist
Novo Nordisk A/S - Per BengtsonLecturerSenior Safety Medical Writer
Ferring Pharmaceuticals A/S - Charlotta Thörn JørgensenLecturerSenior Safety Physician
Ferring Pharmaceuticals A/S - Nicklas Hasselblad LundstrømLecturerPharmacovigilance officer
Lægemiddelstyrelsen - Maurizio SessaLecturerAssistant Professor of Pharmacoepidemiology
Københavns Universitet - Marcus SchartauLecturerSafety Surveillance Risk Management Specialist
Novo Nordisk A/S - Fredrik BrounéusLecturerPharmacist, Communications Officer
Uppsala Monitoring Centre - Cathrina KarupLecturer
Ferring Pharmaceuticals A/S
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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 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
University of Copenhagen
Novo Nordisk A/S
LEO Pharma A/S
Novo Nordisk A/S
Novo Nordisk A/S
Ferring Pharmaceuticals A/S
Ferring Pharmaceuticals A/S
Lægemiddelstyrelsen
Københavns Universitet
Novo Nordisk A/S
Uppsala Monitoring Centre
Ferring Pharmaceuticals 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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