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January 28, 2009

Doctor Irčne FERMONT joins Advanced Drug Development Services as Vice-President PHARMACOVIGILANCE and RISK MANAGEMENT.

This new appointment enables ADDS to offer its clients a comprehensive service in risk management and vigilance at both pre and post marketing stages, extending from consulting to operational activities, such as reception, treatment, notification of adverse reactions to worldwide central agencies, audit, medical writing, PSURs, risk management plans, outsourcing of national and European pharmacovigilance.

Irčne FERMONT, Physician, Immuno-Haematologist and Master of Bioengineering (Ecole Centrale, Paris), has been recognized by the EMEA as a European Qualified Person for Pharmacovigilance (EU-QPPV), and is Eudravigilance certified, allowing an electronic exchange of suspected adverse reaction reports. Her specialisation in Pharmacovigilance makes her a valuable contributor in the field of Pharmacovigilance and Risk Management.

Irčne’s successful career in the pharmaceutical industry stretches over 15 years. She began her career in 1984 as Head of the Bone Marrow Graft Unit and Haemovigilance in the BLOOD BANK OF THE YVELINES. She then created BIOFUSION, specialised in the conception of projects of blood bank turnkey units. In 1997, Irčne joined LEO-PHARMA France as Head of Pharmacovigilance and Medical Information. In 2003 she was appointed Head of International Development by CETONIA. In 2004 Irčne founded her own company, SHIELD RM, providing specialised services in risk management to the pharmaceutical industry and biotechnologies. In 2005, as EU-QPVV, she undertook the organisation of Pharmacovigilance and Medical Information for ALEXION Europe and its subsidiaries. She wrote a European Risk Management Plan for a monoclonal antibody and successfully participated in obtaining its marketing authorisation.