The Pharmacovigilance Unit (UFPV) of the Clinical Research Division of Gustave Roussy performs real-time assessment of the safety of the investigational medicinal products used in nearly 90 clinical trials sponsored by Gustave Roussy or by other academic sponsors, in particular, from the Ile-de-France region (within the framework of GIRCI*). Constant attention is paid to monitoring the safety of investigational medicinal products with regard to potential side effects in patients. This is called pharmacovigilance for clinical trials.
* GIRCI Inter-regional Group for Clinical Research and Innovation
The UFPV performs its safety assessments in accordance with current French and European regulatory requirements, in order to ensure the safety of the patients, both children and adults, who participate in Phase-I to Phase-III studies involving chemotherapy, immune therapy, radiation therapy, medical devices, gene therapy or cell therapy, as well as studies on therapeutic, diagnostic, surgical and/or resuscitation strategies.
The UFPV is composed of physicians and pharmacists who have at their disposal a Web portal for online reporting of SAEs (“my e-clinical”) and dedicated software (EveReport), interfaced with EudraVigilance, the pharmacovigilance database of the European Medicines Agency (EMA).
The UFPV actively contributes to the development of clinical research in France through its participation in the activities of the Coordination of Institutional Sponsors (CPI) and those of the Pharmacovigilance working group (REVISE) of the National Assembly of Delegations for Clinical Research and Innovation (DRCI).
Lastly, the UFPV has a strong commitment to research in the field of pharmacovigilance, through its involvement, in particular, in the SACHA, VIGINOM, REISAMIC and PREMIS studies.
Certification
In 2007, the UFPV became the first academic pharmacovigilance unit in France to achieve ISO 9001 certification for its pharmacovigilance activities in clinical trials. In 2016, the entire Clinical Research Division obtained ISO 9001 certification.
The Team
Head of the Unit
Dr Salim Laghouati
Drug Safety Officer
Dr Helena Cayzac
Pharmacoepidemiology Project Manager
Dr Lee Aymar Ndounga-Diakou
Dr Sabine Messayke
Drug Safety Assistant
Geoffray Cengizalp
Contact
CTpharmacovigilance@gustaveroussy.fr
Research Program in Pharmacovigilance
