The Pharmacovigilance Unit (UFPV) of the Gustave Roussy Clinical Research Division evaluates in real-time the safety of the investigational drugs used in more than 70 clinical trials sponsored by Gustave Roussy and other academic sponsors in the Ile-de-France Region. The monitoring of investigational health products is carried out with great care to detect possible patient side effects. This is referred to as pharmacovigilance of clinical trials.
The UFPV conducts this assessment according to current French and European regulatory requirements (in particular the European Directive 2001/20/EC), to ensure the safety of patients, both adults and children, included in phase I to III trials. This applies to trials involving chemotherapy, immunotherapy, radiotherapy, medical devices, gene or cell therapy and trials of treatment strategy, diagnosis, surgery and/or intensive care.
This unit comprises doctors and pharmacists and is equipped with dedicated software (Safety Easy), which has an interface with the EudraVigilance pharmacovigilance data-base of the European Medicines Agency (EMA).
In addition, the unit is developing a programme of research in pharmacovigilance, including, in particular, the VIGICAIRE and VIGINOM projects.
In 2008 the unit obtained an ISO 9001 certificate for its pharmacovigilance contribution to clinical trials. This was the first pharmacovigilance organisation to be certified in France. Since then the UFPV certificate has been renewed at each annual follow-up inspection performed by AFAQ, the certifying authority (French Association of Quality Assurance).
Head of the Unit : Salim Laghouati
Head of Quality Control : Sylvie Demirdjian
Individual responsible for Pharmacovigilance : Audrey Lallart
Pharmacovigilance Assistant : Geoffray Cengizalp