1st Working Groups Meeting, 2nd CG & MC – Training School.
Málaga 14-15 March 2019
Venue
Hotel
Scientific programmes
Working groups Meeting
1st Working Groups Meeting
Date: 14 March 2019
Time: 08.30h to 18.30h
Venue: Aula Magna, School of Medicine, Blvd L Pasteur 32, 29071. Málaga, Spain
8.30 Registration
8.45 – 9.15 PRO-EURODILI Welcome
9.15-9.45 Chair: Raul J Andrade, Spain
Plenary Lecture: Michael Manns, Germany
How European hepatologists can benefit from the Pro Euro DILI Net Cost?
10.00-11.00 Short presentations from WGs Leaders
Speakers:
WG1 Prof. Jane Groove, Nottingham, UK
WG2 Prof. Gerd A Kullak Ublick, Switzerland
WG3 Prof. José Carlos Fernández Checa, Spain
WG4 Prof. Einar Stefán Björnsson, Iceland
WG5 Dr Simona Stankevičiūtė, Lithuania
11:00- 11:20 Coffee Break
11.20-12.30 Break-out Sessions: WGs Meeting
Each WG Leader: Introduction, Tour de Table
Aims, tasks & Deliverables
12.30-13.00 Chair: Guruprasad Aithal
Plenary Lecture: Ann Daly, Newcastle, UK
DILI as a polygenic disease. International Consortia and DILI initiatives to strengthen knowledge development
13.00-14.30 Lunch Break
14.30-15.00 Chair: Carmen Peralta, Spain
Plenary Lecture: Leo Nelson, Edinburgh, Scotland
Human Models for improved prediction of DILI
15.00-16.45 Break-out sessions
WG1, WG2, WG3, WG4, WG5
16.45-17.00 Coffee Break
17.00-17.30 Chair: Joanna Miranda, Portugal
Plenary Lecture
Andreas Benesic, Munich, Germany
Outreaching biotechnological enterprises in DILI
17.30-18.30 Plenary session (results and conclusion) All
2nd Core Group Meeting
COST Action CA17112
Action Title: Prospective European Drug-Induced Liver Injury Network
Draft Agenda
Second Core Group Meeting
Málaga, Spain
15th March 2019
08:30 – 10:00
Venue: Biblioteca Departamento de Farmacología, Facultad de Medicina, Málaga
- Approval of CG#1 minutes (2019 January 9th, Lisbon, Portugal)
- Report about PRO EURO DILI NET management tasks and Implementation of COST policies
- Internal evaluation of the 1st Grant Period
- Discussion about management rules for activities 2019/20
- STSMs
- Training schools (survey)
- ITC Conference Grant
- Monothematic Conference planning
- Action implementation planning
- Monitoring of the Objective Achievement Indicators for MoU Objectives
- Activity and budget planning (Work and Budget Plan preparation)
- Dissemination strategy/ planning (Publications and outreach activities)
- Any Other Business
- Closing
2nd Management Committee Meeting
COST Action CA17112
Action Title: Prospective European Drug-Induced Liver Injury Network
Draft Agenda
Management Committee Meeting
Málaga, Spain
15th March 2019.
10:30 – 13:00
Venue: Seminar, Department of Pharmacology, School of Medicine.
- Welcome to participants
- Verification of the presence of two-thirds of the Participating COST Countries or, if applicable, a quorum
- Adoption of agenda
- Approval of minutes and matters arising of last meeting
- Update from the Action Chair
- a) Status of Action: start and end dates of Action, participating COST countries, participating NNC/ IPC institutions and Specific Organisations.
- b) Short Term Scientific Missions (STSM): List of centres, topics, dates and ready to take applications
- c) Training Schools: Rules and topics
- Update from the Grant Holder: Action budget status
- Update from the COST Association: Science officer and Administrative Officer
- Monitoring of the Action
- Implementation of COST policies on:
- a) Promotion of gender balance and Early Career Investigators (ECI)
- b) Inclusiveness and Excellence (see below list of Inclusiveness Target Countries)
- Follow-up of MoU objectives: progress report of working groups
- Scientific planning
- a) Scientific strategy (MoU objectives, GP Goals, WG tasks and deliverables)
- b) Action Budget Planning
- c) Long-term planning (including anticipated locations and dates of future activities)
- d) Dissemination planning (Publications and outreach activities)
- Requests to join the Action from:
- a) COST countries
- b) Institutions in Near Neighbouring Countries, International Partner Countries, and/or Specific Organisations
- AOB
- Location and date of next meeting
- Summary of MC decisions
- Closing
Training School
1st TRAINING COURSE, ACTION COST 17-112
PRO EURO DILI NET
ASSESSMENT OF DRUG-INDUCED LIVER INJURY: KEY RULES AND COMMON PITFALLS. HOW TO MAKE A CLINICAL NARRATIVE
We are currently working in order to achieve ERT (Eurotox) recognition for the course.
Date: 15 March 2019
Time: 08.30h to 19.00h
Venue: Aula Magna, School of Medicine, Blvd L Pasteur 32, 29071. Málaga, Spain
Registration form: https://goo.gl/forms/MspTgxQb4ts3NSNJ3
Overview
Idiosyncratic drug-induced liver injury (DILI) is an acute adverse hepatic reaction that occurs in only a small proportion of individuals exposed to a drug, it is unexpected from the known pharmacological action of the agent, leading to illness, disability, hospitalization, including life threatening liver failure and death or need for liver transplantation. DILI represents a major challenge for clinicians, the pharmaceutical industry and regulatory agencies worldwide as it stands as one of the main causes of drug attrition during development and the adoption of regulatory measures to improve clinical safety. There is a clear need for a deeper understanding of this complex and intriguing disorder.
To achieve this objective regulatory bodies and professionals from the pharmacovigilance arena should develop skills in DILI recognition through an update on the key criteria used for DILI diagnosis and its in-depth phenotyping. This course will combine conceptual talks with problem-solving learning exercises to help translate the knowledge into a real world setting.
Learning Objectives
This training course in DILI will enable to
- Make a proper DILI case definition and phenotype classification and a case narrative
- Recognize the drugs most commonly involved in DILI and the scientific evidence to support it
- Work-out the minimal elements to make a proper DILI case adjudication
- Balance the value of the diagnostic scales used for DILI assessment
- Recognize the role of liver tests monitoring in preventing/minimizing DILI risk
Assessment
The assessment is based on a written MCQ examination on the last day of the course
Scientific Program (Agenda)
Day 15 March 2019
08.30 REGISTRATION
08.45h Introduction, opening statements and presentations
Raúl J Andrade
09.00 / 09.30 Risk Minimization Strategies. Why DILI initiative is important?
09.30 / 10.00 Drug-induced liver injury: general concepts, interpretation of liver tests and common mistakes.
10.00 /10.30 COFFEE BREAK
10.30 / 11.15 Case definition and phenotypes. Grading Severity and Predicting outcome in DILI. The benefits of Registries
Guruprasad Aithal, UK
11.15 / 12.00 New approaches to DILI identification using electronic medical records
12.00 / 13.15 How to face a DILI suspicion
A clinical algorithm for diagnostic approach:
Clinical Vignettes
Guido Stirnimann, Switzerland
13.15 / 14.30 LUNCH
14.30 / 15.00 Minimal data elements for proper DILI adjudication. Case study on a published DILI case.
15.00 / 15.45 How to prepare a case narrative
15.45 / 16.15 COFFEE BREAK
16.15 / 16.45 Causality assessment scales: strengths and weaknesses
16.45 / 18.30 Introduction to breakout groups for assessment of DILI cases (Spain)
18.30 / 19.00 Closing remarks and Assessment (written MCQs)