DILI: Clinical Trials and Post-Marketing
This new DIA training course is entirely dedicated to Drug-Induced Liver Injury (DILI). It is led by a Hepatologist with extensive experience in clinical assessment of DILI and who published ‘RUCAM’ the widely used causality assessment method of DILI. The course will cover the progress that has been made in the clinical detection and prevention of DILI in clinical trials and in post marketing phase. Regulatory guidelines need to be understood for an optimal assessment of DILI cases. Better use of typical tools will be emphasised in order to improve patient safety and drug monitoring in new drug development, especially in large populations. This course will provide tools, explanations, examples and several exercises for a better understanding of DILI and how best to apply that knowledge in day-to-day work.
This training course is designed to be followed as a stand-alone course for those who would like to increase their knowledge on DILI or as an advised complement to the course titled Medical Approach in Diagnosis and Management of ADRs, which is taking place in the same venue immediately before the DILI Training Course.
What participants from previous course say:
"Very excellent course/training, I will recommend it to my colleagues"
"I thought the course was very good and applicable to my immediate work situation. I will be taking many things back to my clinical team to use in assessing current issues"
Who should attend?
All healthcare professionals involved in the monitoring and assessment of DILI occurring in development or after marketing:
- EU Qualified Persons for Pharmacovigilance
- People in charge of pharmacovigilance in regulatory authorities and in companies
- Safety assessors in clinical trials and postmarketing
- Clinical Research Associates
At the conclusion of this training course participants will be able to:
- Define and classify Drug-Induced Liver Injuries
- Describe DILI clinical patterns and aetiological investigations
- Discuss specifically DILI during clinical trials and in post-marketing
- Assess causality of DILI
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.