Summary
This three day course will help you understand the clinical manifestations of adverse drug reactions (ADRs) in different organ systems. You will learn the definitions, the general terminology and the classification of adverse events (AEs) and ADRs. You will also learn methods to determine the causal relationship in single case reports and to understand the principles of causal relationship assessments in single case reports.
The course is offered once a year.
Other course participants say
"Highly constructive and educational course with engaging topics."
Mette Seiffert, Senior Drug Safety Associate, ALK-Abelló A/S
"I learnt a lot of new things and the course was well-organised and interesting"
Tasnim Dayeh, Pharmacovigilance manager, Medical Valley Invest AB
"A remarkably informative course with some very good presenters!"
Maria Blakø, Senior Safety Data Associate, H. Lundbeck A/S
Keywords
- Drug safety
- Drug-induced adverse events
- Principles of causality assessment
- Safety considerations for new drug modalities
- Discussions of real life cases
Save information for later
Course leader & lecturers
- Terrie Ramirez-AndersenCourse leaderSenior Director, Clinical Research Scientists, Medical Oncology
Genmab A/S - Claudia Pierleoni-NielsenCourse leaderDirector, Head of Safety Surveillance, Global Safety
LEO Pharma A/S
Watch the video
Is this course for you?
This course is for you who have a background as a nurse, doctor, pharmacist, biologist, or human physiologist. You work within clinical development, within Medical Science, or the like. Alternative you work within PV as coordinator/officer, QPPV professional, or safety surveillance officer. To benefit fully, you should have some experience in the field.
What you will learn
- The clinical manifestations of adverse drug reactions in different organ systems
- How to analyze and evaluate the clinical consequences of drug use and the ADR risk
- How to incorporate pharmacokinetic variance, drug-drug interactions, and pharmacogenetics into ADR risk assessments
- How to perform causality assessments and evaluate reports
What your company will get
- A safety and pharmacovigilance professional who understands the clinical manifestations of ADRs in different organ systems
- A safety and pharmacovigilance professional who can independently analyze and evaluate the clinical consequences of drug use and the adverse drug reaction risk
- A safety and pharmacovigilance professional who can provide valuable input to other team members working with clinical manifestations of adverse drug reactions in different organ systems
Course calendar
Day 1
- Causality Assessment in Single Case Reports
- Drugs and Hepatotoxicity
- Pharmacokinetics and Pharmacodynamics in Relation to Adverse Drug Reactions
- Adverse Drug Effects on CNS
Day 2
Drugs and Renal Function
Cardiovascular adverse drug reactions
Drug Use in Pregnancy and Lactation
Day 3
- Cutaneous Adverse Drug Reactions
- Hematological Adverse Drug Reactions
- Safety Considerations of Antibody Therapeutics
- siRNA: An Emerging Therapeutic Format and its Safety Profile
Registration
Registration deadline9 Mar 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
This course is for you who have a background as a nurse, medical doctor, pharmacist, human biologist, and work in the pharmaceutical industry or regulatory authorities within the area of drug safety, clinical research and regulatory affairs.
Basic understanding and knowledge of medical concepts and of pathophysiology is a must.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
This course is a part of a diploma
The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.
Read moreCourse leaders
Genmab A/S
LEO Pharma A/S
You may also be interested in these courses
16 Apr 2026
•
Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
Send me a message