Adverse Drug Reactions by Body Systems

Understand the clinical manifestations of adverse drug reactions in different organ systems

Date icon

18 - 20 Nov 2024

Attendance icon

On location

Language icon

English

Price icon
20,100 DKK ex VAT

(app. 2,702 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

"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."


"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
Read more

Course leader & lecturers

  • Claudia Pierleoni-Nielsen
    Course leader
    Director, Head of Safety Surveillance, Global Safety
    Leo Pharma A/S
  • Terrie Ramirez-Andersen
    Course leader
    Director, Clinical Research Scientists, Medical Oncology
    Genmab A/S
  • Laura Højland Larsen
    Lecturer
    Associate Director, Global Drug Safety & Pharmacovigilance Scientist
    Genmab A/S
  • Emma Tina Bisgaard Olesen
    Lecturer
    Assistant professor, resident in nephrology, MD, PhD
    Københavns Universitet, Biomedicinsk Institut (BMI)
  • Hans Eriksson
    Lecturer
    MD, PhD, MBA, Chief Medical Officer
    HMNC Holding GmbH
  • Niclas Petri
    Lecturer
    Sr Principal Clinical Pharmacology Specialist
    Novo Nordisk A/S
  • Maja Mockenhaupt
    Lecturer
    Managing senior physician, head of the German Registry of severe skin reactions
    University of Freiburg
  • Lasse Steen Ravn
    Lecturer
    International Medical Director
    Novo Nordisk A/S
  • Saher Burhan Shaker
    Lecturer
    Consultant in Respiratory Medicine, Associate professor,Life PhD
    Region Hovedstaden
  • Hanne Kjær Offenberg
    Lecturer
    Non-Clinical Project Director
    Novo Nordisk A/S
  • Trine Trab
    Lecturer
    MD, PhD student
    Rigshospitalet
  • Stine Larsen
    Lecturer
    CEO
    EASE Consulting ApS
  • Jon Trærup Andersen
    Lecturer
    Prof., Leading Physician, ph.d.
    Bispebjerg og Frederiksberg Hospital
See all

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

  1. The clinical manifestations of adverse drug reactions in different organ systems
  2. How to analyze and evaluate the clinical consequences of drug use and the ADR risk
  3. How to incorporate pharmacokinetic variance, drug-drug interactions, and pharmacogenetics into ADR risk assessments
  4. How to perform causality assessments and evaluate reports

What your company will get

  1. A safety and pharmacovigilance professional who understands the clinical manifestations of ADRs in different organ systems
  2. A safety and pharmacovigilance professional who can independently analyze and evaluate the clinical consequences of drug use and the adverse drug reaction risk
  3. 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

Starting 18 Nov 2024
18 Nov 2024 9:00-16:00
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
19 Nov 2024 9:00-16:00
Day 2
  • Drugs and Renal Function

  • Cardiovascular adverse drug reactions

  • Drug Use in Pregnancy and Lactation

20 Nov 2024 9:00-16:00
Day 3
  • Cutaneous Adverse Drug Reactions
  • Hematological Adverse Drug Reactions
  • Safety Considerations of Antibody Therapeutics
  • siRNA: An Emerging Therapeutic Format and its Safety Profile
Practical information

Related exams

8 Jan 2025 10:00-13:00
Go to exam page

Registration

Registration deadline
11 Nov 2024
Register
18 - 20 Nov
Sometimes things change. This is the expected programme.

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

Diploma in Pharmacovigilance

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 more

Course leaders

Claudia Pierleoni-Nielsen
Director, Head of Safety Surveillance, Global Safety
Leo Pharma A/S
Terrie Ramirez-Andersen
Director, Clinical Research Scientists, Medical Oncology
Genmab A/S

Lecturers

Laura Højland Larsen
Associate Director, Global Drug Safety & Pharmacovigilance Scientist
Genmab A/S
Emma Tina Bisgaard Olesen
Assistant professor, resident in nephrology, MD, PhD
Københavns Universitet, Biomedicinsk Institut (BMI)
Hans Eriksson
MD, PhD, MBA, Chief Medical Officer
HMNC Holding GmbH
Niclas Petri
Sr Principal Clinical Pharmacology Specialist
Novo Nordisk A/S
Maja Mockenhaupt
Managing senior physician, head of the German Registry of severe skin reactions
University of Freiburg
Lasse Steen Ravn
International Medical Director
Novo Nordisk A/S
Saher Burhan Shaker
Consultant in Respiratory Medicine, Associate professor,Life PhD
Region Hovedstaden
Hanne Kjær Offenberg
Non-Clinical Project Director
Novo Nordisk A/S
Trine Trab
MD, PhD student
Rigshospitalet
Stine Larsen
CEO
EASE Consulting ApS
Jon Trærup Andersen
Prof., Leading Physician, ph.d.
Bispebjerg og Frederiksberg Hospital

You may also be interested in these courses

Want to know more or need help?

Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

Send me a message