Brigitte Lopez

Brigitte Lopez

Senior Director Regulatory Affairs France

Key Knowledge Areas:

- French legislation
- DMOS
- Charte Visite Médicale

Brigitte is a pharmacist and completed her Pharmaceutical education at the Faculty of Bordeaux, France (Thesis on “Création, mise en place et avenir du Common Technical Document”). She also holds a DESS (Master) in “Marketing Management et Droit des Industries de Santé » from the University of Bordeaux, France (1999).

 

Brigitte started her professional career in 1999 where she held the position of Regulatory Affairs Manager France and Export at Theramex in Monaco. She was in charge of the Marketing Authorizations in Gynecology (registration and control of promotional materials) as well as registrations in Latin America, Maghreb and Middle East.

 

In 2001 she was appointed to Regulatory Affairs Manager Europe and Export and was in charge of the registrations (MRP and national procedures) and of the Asia, South Africa and French-speaking African areas supervision. Brigitte was managing the coordination and was involved in many R&D and Business Development project teams. She also took the lead of the electronic regulatory watchdog development and organized the electronic documentation management within the company.

In 2005 Brigitte joined Allergan France as Senior Regulatory Affairs Manager. She was responsible for managing the local registration, maintenance and promotional documentation control of the products portfolio in ophthalmology, neurology and dermatology and was in charge of specific activities linked to the French legislation (Early access program, regulatory intelligence on medical devices..).

 

She was appointed QP deputy of the “Exploitant” pharmaceutical company in Mougins and actively participated in the compliance with a specific Code of Practice (“Charte de la Visite Médicale”) implementation.

 

In 2010, Brigitte left the Pharmaceutical industry and moved to consultancy and finally joined BLUE-REG PHARMA CONSULT in 2012

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