The 22nd edition of this annual training course, considered by many experts as one of the pillars of medical training in pharmacovigilance, focuses on how to use medical knowledge in the diagnosis and management of selected Adverse Drug Reactions (ADRs). ADRs of the main systems/organs will be presented and explained by experts in their medical domain in order to provide practical clues to understand and manage the serious reactions in clinical trials a well as in post authorisation.
A medical approach is needed for the identification, labelling and understanding of ADR mechanisms. It can also help assess the probability that a medicinal product may have played a role in the occurrence of an adverse event. This is particularly useful for the first 2 or 3 cases of serious reactions occurring during clinical trials when important decisions must be taken regarding a new drug under development.
The medical approach presented in this training course will take into consideration the conclusions of international or national consensus meetings on adverse drug reactions.
This course can be complemented by Diagnosis and Management of Drug-Induced Liver Injury (DILI) training course, scheduled in the same venue directly after this course.
What participants from previous course say:
"A good overview of major organ involvement - each topic could easily fill a full day in the programme. Enjoyed the concepts presented in the affective symptoms session"
"Good take home messages"
"Dr Gaby Danan is a medical doctor that not only has a great knowledge in the field he works, but also is an excellent presenter, he knows how to keep the audience engaged. He not only explains the theoretical part, but also gives practical examples"
Who should attend?
All healthcare professionals involved in the monitoring and assessment of adverse drug reactions occurred in drug development or after marketing; EU–QPPV, staff in charge of pharmacovigilance and/or drug safety investigators, staff in charge of clinical trials and safety studies, clinical research associates and monitors.
At the conclusion of this training course participants will be able to:
- Classify and define drug-induced affective symptoms, skin reactions, QT interval prolongation, blood disorders and acute renal failure
- Describe their clinical patterns and appropriate investigations
- Discuss the main non drug causes of the described disorders
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Gaby L. Danan, MD, PhD • Pharmacovigilance Expert
Philippe Nuss, MD • Psychiatrist
Hopital Saint-Antoine, Service de Psychiatrie, France
Sarah Walsh, MD • Consultant Dermatologist
King’s College Hospital, United Kingdom