This brand new DIA training course is entirely dedicated to Drug-Induced Liver Injury (DILI) and led by a Hepatologist with extensive experience in clinical assessment of DILI, 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 postmarketing phase. New regulatory guidelines and their application need to be understood for an optimal assessment of DILI cases. Better use of typical tools is emphasised in order to improve patient safety and drug monitoring during new drug development, especially in large populations. This course will provide tools, explanations, examples and exercises for a better understanding of DILI and how best to apply that knowledge in day to day work.
The medical approach presented in this training course is also based on the conclusions of international consensus meetings on adverse drug reactions and guidelines published by regulatory authorities
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 should 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
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
Hotel ibis Berthier Porte de Clichy
163 bis avenue de Clichy
75017 – PARIS, FRANCE
Tel.: +33 1 40 25 20 20
at the rates of:
18th of September: EUR 139.00
19th of September: EUR 134.00
per room inclusive of breakfast, VAT, taxes.
To make your reservation, please use this booking form.
Important: The room rate is available until 18 August 2013 or until the group block is sold-out, whichever comes first.
In case of cancellation:
The room can be cancelled before 6pm the day before the arrival, after that the credit card will be charged for the 1st night.
KUECHENGASSE 16, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52