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Estelle ICARD

PARIS

En résumé

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

    SaintCloud 2013 - maintenant Hybrid 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

    Courbevoie 2011 - 2013 New 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

  • Laboratoire BIOGARAN - Marketing trainee (health professionals)

    2011 - 2011 Assistance 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 - 2011 Dispensing of human and veterinary medicines

Formations

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