1st Working Groups Meeting – 2nd CG & MC – Training School Málaga 14-15 March 2019

1st Working Groups Meeting – 2nd CG & MC – Training School Málaga 14-15 March 2019
09/23/2018 Aurelie Papineau

1st Working Groups Meeting, 2nd CG & MC – Training School.

Málaga 14-15 March 2019



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


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

  1. Approval of CG#1 minutes (2019 January 9th, Lisbon, Portugal)
  2. Report about PRO EURO DILI NET management tasks and Implementation of COST policies
  3. Internal evaluation of the 1st Grant Period
  4. Discussion about management rules for activities 2019/20
    1. STSMs
    2. Training schools (survey)
    3. ITC Conference Grant
    4. Monothematic Conference planning
  5. Action implementation planning
    1. Monitoring of the Objective Achievement Indicators for MoU Objectives
    2. Activity and budget planning (Work and Budget Plan preparation)
    3. Dissemination strategy/ planning (Publications and outreach activities)
  6. Any Other Business
  7. 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.

  1. Welcome to participants
  2. Verification of the presence of two-thirds of the Participating COST Countries or, if applicable, a quorum
  3. Adoption of agenda
  4. Approval of minutes and matters arising of last meeting
  5. Update from the Action Chair
  6. a) Status of Action: start and end dates of Action, participating COST countries, participating NNC/ IPC institutions and Specific Organisations.
  7. b) Short Term Scientific Missions (STSM): List of centres, topics, dates and ready to take applications
  8. c) Training Schools: Rules and topics
  9. Update from the Grant Holder: Action budget status
  10. Update from the COST Association: Science officer and Administrative Officer
  11. Monitoring of the Action
  12. Implementation of COST policies on:
  13. a) Promotion of gender balance and Early Career Investigators (ECI)
  14. b) Inclusiveness and Excellence (see below list of Inclusiveness Target Countries)
  15. Follow-up of MoU objectives: progress report of working groups
  16. Scientific planning
  17. a) Scientific strategy (MoU objectives, GP Goals, WG tasks and deliverables)
  18. b) Action Budget Planning
  19. c) Long-term planning (including anticipated locations and dates of future activities)
  20. d) Dissemination planning (Publications and outreach activities)
  21. Requests to join the Action from:
  22. a) COST countries
  23. b) Institutions in Near Neighbouring Countries, International Partner Countries, and/or Specific Organisations
  24. AOB
  25. Location and date of next meeting
  26. Summary of MC decisions
  27. Closing

Training School





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



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



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?

Herve Le Louet, France

09.30 / 10.00         Drug-induced liver injury: general concepts, interpretation of  liver tests and common mistakes.

Raúl J Andrade, Spain

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

Ayako Suzuki, USA

12.00 / 13.15           How to face a DILI suspicion

A clinical algorithm for diagnostic approach:

                                 Mercedes Robles, Spain

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.

                                M Isabel Lucena, Spain

15.00 / 15.45           How to prepare a case narrative

                                Einar Björnsson, Iceland     

15.45 / 16.15         COFFEE BREAK     

16.15 / 16.45            Causality assessment scales: strengths and weaknesses

Miren Garcia-Cortes, Spain

16.45 / 18.30           Introduction to breakout groups for assessment of DILI cases (Spain)

                                 Miren Garcia-Cortes, Camilla Stephens, Aida Ortega-Alonso, Mercedes Robles-Diaz, Judith Sanabria, Spain

18.30 / 19.00           Closing remarks and Assessment (written MCQs)