Summary
This 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:
"Targeted and relevant knowledge that can be applied in your daily pharmacovigilance work."
Dumoue Qasem, Senior Safety Surveillance Adviser, Novo Nordisk
"It's three very intense days of learning the important basics for medical evaluation in pharmacovigilance. Atrium’s courses are a really nice platform for discussion and socialising with colleagues in the field."
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Keywords
- Classification of Adverse Drug Reactions (ADRs)
- Causation in Single Case Reports
- Classification Systems for ADRs
- Adverse Effects of Drugs on Organ Systems
- Drug Use in Pregnancy and Lactation
- Drug Safety in Pediatric Patients
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Course leader & lecturers
- Claudia Pierleoni-NielsenCourse leaderHead of Safety Surveillance, Global Safety
Leo Pharma A/S - Terrie Ramirez-AndersenCourse leaderDirector, Clinical Research Scientists, Medical Oncology
Genmab A/S
Is this course for you?
This course is for you who have a background as a nurse, doctor, pharmacist, biologist, or human physiologist and work as e.g. PV 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 use and perform causality assessments and evaluate reports
- A comprehensive view of good pharmacovigilance practice
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
- An employee who can play an important role in any project team working with adverse drug reactions
Course calendar
Day 1
- Introduction
- Assessment of causal relationship in single case reports, general methodology
- Drugs and hepatotoxicity
- Workshop
- Drugs and renal function
- The effects of drugs on the immune system
- Local and systemic side effects of drugs on skin
Day 2
- Adverse effects of drugs on the central nervous system (CNS)
- Adverse effects of centrally acting drugs
- The effects of drugs on the hematopoietic system
Day 3
- Cardiovascular ADRs with cardiovascular and non cardiovascular medicine
- Workshop
- Drug use in pregnancy and lactation
- Drug safety in pediatric patients
Registration
Registration deadline8 Nov 2023
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
Leo Pharma A/S
Genmab 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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