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Université Bordeaux 2 CHU de Bordeaux INSERM
Département Hospitalo-Universitaire de Pharmacologie de Bordeaux
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European projects of the Bordeaux Pharmacology Department

imi-train : Education and Training in the Medical, Biomedical and Pharmaceutical Sciences

imi-train is an Education and Training project in the medical, biomedical and pharmaceutical sciences funded by the European programme Innovative Medicines Initiative (IMI). IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.

imi-train gathers the first four IMI E&T projects: EMTRAIN, Eu2P, PharmaTrain and SafeSciMET. Its main objectives are to:

  • Strengthen all IMI E&T projects awareness and promotion: EMTRAIN, Eu2P, PharmaTrain, SafeSciMET and EUPATI
  • Index, promote and develop the European training offer for medicines lifecycle job market such as university curricula or continuing education formats awarded by academic Certificates, Master or PhD degrees or Continuing Professional Development (CPD) credits
  • Define and develop competence profiles for medicines lifecycle job market at the European level and sign post related training offers

As Eu2P academic and operational coordinator, the Department of Pharmacology from Bordeaux is co-leading:

  • The Steering Committee group: Dr Annie Fourrier-Réglat
  • The Work Package 1 on imi-train promotion: Stéphane Liège
  • The Work Package 2 on Personalized training: Dr Karine Palin

Within these groups, the Department of Pharmacology from Bordeaux is actively contributing to:

  • The design and implementation of the imi-train communication strategy and visual identity as well as the development and daily management of online communication tools (website, social networks) in order to promote the imi-train and IMI E&T programmes awareness and achievements.
    Find out more: imi-train website | @imitrain
  • Develop a new Eu2P course offer in shorter format (30 to 120 min) in pharmacovigilance and pharmacoepidemiology. These short courses offer convenient ways to get trained in narrowly targeted fields and in a restricted study time availability framework in order to fit individuals, SMEs and Pharma industry departments needs in drug safety.
    Find out more: Eu2P training offer overview | Eu2P for healthcare professionals
  • Help the SafeSciMET training programme developing a new blended learning offer (online and face-to-face course formats) using Eu2P online training platform and eLearning expertise.
    Find out more: SafeSciMET description | SafeSciMET blended course development with Eu2P

 

 

Eu2P : European programme in Pharmacovigilance and Pharmacoepidemiology

The European Commission through the Innovative Medicines Initiative wants to revolutionise drug research by providing highly-skilled medicines stakeholders. For the first time in the history of pharmaceutical research, big companies are working with universities, patients and regulators, to share their knowledge and expertise for a common education and training objective.

Eu2P is the first European public-private education and training initiative to improve the benefit and risk of medicines.

Seven Universities, the European and French Medicines Agencies and fifteen Pharmaceutical Companies have put their strengths together to meet the job market needs for healthcare professionals, students and non-specialists. They provide training in medicines benefit assessment, regulatory aspects, risk quantification, public health and risk communication. Eu2P offers valuable diplomas: one Master, one PhD and Certificates jointly awarded by all public and private partners. Emphasis is put on hands-on training to maximise post-training employment opportunities.

By joining Eu2P, all stakeholders choose e-learning to learn with experts in pharmacovigilance and pharmacoepidemiology at anytime, anyplace.

 

Academic coordinator : Dr A. Fourrier-Réglat
Project coordinator: Dr A. Adesina

 

Contact
Eu2P Central Office
Dr Karine Palin / Christa Bataille
e-mail: eu2p.office@eu2p.org
Tel: +33 (0) 557579257
Fax: +33 (0) 557575653
Website: https://www.eu2p.org

 

 

SALT-I: Study of Acute Liver Transplant

A study of NSAIDs-exposed acute liver failure (ALF) in European transplant centres
The SALT-I study was a European pharmacoepidemiological study of patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs) registered for liver transplantation because of acute liver failure (ALF). This multicentre, multinational study was conducted at liver transplant centres in seven European countries.

The study was conducted at the request of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, independently from the financer Helsinn Healthcare SA.

The SALT-1 study was coordinated by Prof. Nicholas Moore, the Department Head. Assoc. Prof. S. Ezgi Gülmez, physician and pharmacologist, was the scientific coordinator, in strict collaboration with Prof. Dominique Larrey, Department of Hepatogastroenterology, Saint-Eloi Hospital (Montpellier). Séverine Lignot-Maleyran was the project manager.

The designated independent Scientific Committee monitored the scientific quality of the project and data analysis. The Case Adjudication Committee reviewed and adjudicated the cases. The National Case Selection Committee, designated in each participating country, followed the case selection process.


Context
NSAIDs and paracetamol are thought to be common causes of acute liver failure (ALF) leading to liver transplantation.


Objectives
To estimate the risk of ALF leading to registration for liver transplantation in patients without identified clinical etiology and exposed to NSAIDs and paracetamol.


Methods
Multicentre, case-population study performed in France, Greece, Ireland, Italy, Netherlands, Portugal, and UK between 2005-2007 in adults. Patients were identified by national/local LT registries. Demographic, clinical, and drug use data were collected for ALF cases without identified clinical etiology. Exposure to NSAID or paracetamol was determined within 30 days prior to initial symptoms of liver disease. Rate per million treatment-years was calculated using sales data from IMS.


Results
Of the 62 LT centers, 57 were eligible, and 52 contributed data. Among the 9479 patients identified from LT lists for the 3-year period, 600 (6%) were ALF: 219 (36% of all-cause ALF) had an identified clinical etiology, 18 (3% of all-cause ALF) had unavailable medical files, 62 (11%) were not drug-exposed and had no identified clinical etiology, and 301 (52%) were drug-exposed without identified clinical etiology. Among the latter, 40 (7% of analyzable ALF) were exposed to NSAIDs, mean age 43.9 years, 29 (72%) female. Event rates per million treatment-years were 4.78 (95%CI, 3.42-6.51) for all NSAIDs pooled, 6.84 (3.64-11.69) for ibuprofen, 5.64 (2.43-11.11) for nimesulide, 4.66 (1.71-10.14) for diclofenac, 4.64 (0.96-13.56) for ketoprofen, and 4.89 (0.59-17.66) for naproxen. Event rate for non-over dose paracetamol was 9.93 (7.89-12.34), and 23.53 (20.32-27.11) when intentional or non-intentional overdoses were included. Event rates for all NSAID pooled were 3.9 (95%CI 1.2-12.5) times higher in Ireland than in all countries pooled, than all countries pooled.


Conclusion
The risk of acute liver failure leading to registration for liver transplantation was rare and showed no differences among the most used NSAIDs. Non-overdose paracetamol-exposed ALF was twice more common than NSAID-exposed ALF.

 

 

EUTOS : EUropean Treatment Outcome Study

EUTOS is a collaboration between the European LeukemiaNet and Novartis.

EUTOS aims to improve the understanding of Chronic Myeloid Leukemia (CML), promote best practise, and enhance treatment outcomes thoughout Europe for patients treated with imatinib.

The Pharmacotoxicology Laboratory, lead by Pr M. Molimard and Dr K. Titier, have been selected as European centre of reference and expertise for imatinib plasma level determination in the therapeutic drug monitoring of patients with CML [3-4].


References
1. O’Brien et al. N Engl J Med 2003;348:994–1004
2. Peggs et al. N Engl J Med 2003;348:1048–50
3. Picard et al. Blood. 2007;15;109 (8):3496-9.
4. Titier et al.Ther Drug Monit. 2005;27 (5):634-40

 

 

EU-ADR :

EU-ADR is a Research and Development project funded by the Information and Communication Technologies (ICT) Area of the European Commission under the VII Framework Programme and coordinated by Prof Johan van der Lei from Erasmus University Medical Center.

EU-ADR aims to develop an innovative computerized system to detect adverse drug reactions (ADRs), supplementing spontaneous reporting systems.

 

The Bordeaux Department of Pharmacology, under the coordination of Annie Fourrier-Réglat and Antoine Pariente, together with Bordeaux ISPED members (F. Thiessard, P. Avillach & F. Mougin) and the Sicilian Regional Pharmacovigilance centre (Neurolesi, Messine) is generating a pharmacovigilance relevant event list to test the valididy of the computerized ADR detection system.

 

 

SOS : The Safety Of non-Steroidal anti-inflammatory drugs

SOS is a Research and Development project funded by the Health Area of the European Commission under the VII Framework Programme and coordinated by Prof Miriam CJM Sturkenboom from Erasmus University Medical Center.

SOS aims to assess and compare the risk of cardiovascular and gastrointestinal events of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in order to provide clinicians and regulatory authorities, such as medicine agencies, with decision models.

The Bordeaux Department of Pharmacology, under the coordination of Nicholas Moore, Annie Fourrier-Réglat and Antoine Pariente, together with the RTI Health Solutions epidemiology center in Barcelona (S. Pérez-Gutthann), is analyzing the available clinical trials data on cardiovascular and gastrointestinal risks related to NSAIDs.