Pharmacovigilance Functional Unit (UFPV)

The Pharmacovigilance Functional Unit (UFPV) of the Clinical Research Department at Gustave Roussy evaluates in real time the tolerability of experimental treatments used in nearly 90 clinical trials sponsored by Gustave Roussy or by other academic sponsors, particularly those in the Île-de-France region (as part of the GIRCI). The monitoring of investigational medicinal products is subject to close scrutiny with regard to any side effects observed in patients. This is known as clinical trial pharmacovigilance.

The UFPV conducts this evaluation in accordance with current French and European regulatory requirements to ensure the safety of patients enrolled in Phase I through III trials—involving both adults and children—that include chemotherapy, immunotherapy, radiation therapy, medical devices, gene or cell therapy, as well as trials involving therapeutic strategies, diagnostics, surgery, and/or intensive care.

Composed of physicians and pharmacists, this unit has a web portal for the electronic reporting of serious adverse events (my eclinical) and dedicated software (EveReport), which interfaces with the European Medicines Agency’s (EMA) EudraVigilance pharmacovigilance database.

The Unit actively contributes to the advancement of clinical research in France through its participation in the activities of the Coordination of Institutional Sponsors (CPI) and the Pharmacovigilance Working Group (REVISE) of the National Assembly of DRCI.

Finally, the Unit is developing a pharmacovigilance research program, including notably the SACHA, VIGINOM, REISAMIC, and PREMIS projects.

Certification

In 2007, the Unit obtained ISO 9001 certification for its pharmacovigilance activities in clinical trials. It was the first pharmacovigilance organization to be certified in France. Since 2016, the entire Clinical Research Department has been ISO 9001 certified.

Members of the Pharmacovigilance Functional Unit

• Head
  : Dr. Salim Laghouati
• Pharmacovigilance
  Officer: Dr. Helena Cayzac
• Pharmacological
  Epidemiology Research Coordinators: Lee Aymar Ndounga-diakou
  , Sabine Messayke
• Pharmacovigilance
  Assistant: Geoffray Cengizalp