Mes compétences :
Réglementation Européenne
Veille réglementaire
Procédure de reconnaissance Mutuelle
Entreprises
Planetpharma Groupe Ubipharm
- Pharmacien Adjoint Distribution
2017 - maintenant
Ethypharm
- European Procedures Coordinator - Regulatory Affairs
SaintCloud2013 - maintenantHybrid and generic MA Applications through European procedures (DCP, MRP): new applications, slots, renewals, licences variations and transfer
Follow-up of ongoing applications during the European phase and until the finalization of the national phases (follow-up with health Authorities, partners, manufacturing sites).
Module 1: wrote Administrative and Prescribing Information of MA
Scientific Advice Applications
ECTD submission ( eCTDXPress, EURS Validator, LORENZ eValidator, Eudralink, CESP), according to national requirements,
European Regulatory Intelligence
Laboratoires EXPANSCIENCE
- International Regulatory Affairs Pharmacist
Courbevoie2011 - 2013New application, renewal and variation submissions of Marketing Authorization in Europe (DCP, MRP, national) and export( CIS, Asia and Africa)
Validation of packaging
XEVMPD : submission of details for all the products in EU
Regulatory Intelligence
2011 - 2011Assistance for communication campaigns aimed at health professionnals: e-mailing, advertisement
Preparation of promotional materials for the sales force
Organization of seminars
Pharmacie du Cygne de Croix, Caen
- Pharmacy Student
2007 - 2011Dispensing of human and veterinary medicines
