Menu

Loetitia JABRI GUERNEZ

PARIS

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Paris.

En résumé

Domaines d'activités: Santé (pharmaceutique, cosmétique, dispositif médical), Environnement, Ecologie


PHARMACY, HEALTH & QUALITY :
Development, Strategy and Management with the EU Competent Health Authorities for :
•Drugs (medicinal and veterinary use)
•Medical Devices
•Cosmetics
•Food additives.

Regulatory and economics affairs, quality assurance, clinical trias : http://www.int-pharmaceutical-consultancy.fr/activites_en.php

ENVIRONNEMENT ET ECOLOGIE : études d'impacts,écologiques et environnementales, conseil réglementaire

Mes compétences :
Audits
AUDITS ENVIRONNEMENTAUX
Audits internes
Consulting
Études d'impact

Entreprises

  • IPC - Consultante Sénior Industrie Pharmaceutique

    2003 - maintenant IPC - Since 2003 > International Pharmaceutical Consultancy – Neuilly (92)
    Quality Assurance: quality intern & extern audits, quality system & SOP redaction, quality formations
    Regulatory Affairs France/ Europe: MA files, pricing files, CE and LPP marking files, Cosmetic products files, DM CE marking files, nutrition products files, Formations
    Clinical Research: Redaction of protocols/CRF/study documents, Regulatory submissions, Management of studies, Monitoring according BPC/ICH of phases I /II /III, IV clinical trials; Clinical reports

  • LEEM - Chargée de missions

    2003 - 2003 LEEM - 2003 > Les Entreprises du Médicament, Leem – Paris (75)
    Regulatory Affairs France/ Europe : Working groups « ERA » and « FRA », « Environment/Pharmaceutical firms 2003 » study, « Revision of the Pharmaceutical Legislation », and « Essentially similar products » study, follow up of MA, National, MR and centralised procedures, answer to the firms questions, meetings with the AFSSAPS, regulation follow-up

  • GSK - Responsable d'Essais R&D

    2002 - 2002 GSK 2002 > GlaxoSmithKline – Marly-Le-Roi (78)
    Clinical Research Coach CNS, gastroenterology, urology Department:
    International multicentric clinical research projects (trial management, writing of protocol, summary, informed consent, financing follow up, feasibility, submission to Regulatory Authorities, monitoring : initiation site visit, verification of trial data and conduct in compliance with GCP, SOPs, BPC, ethical laws and applicable regulations, verification of investigational products, management of AEs and SAEs and withdrawals, CRO and sites audits, queries follow up, submission of written report of site visit, final visit

Formations

Réseau

Annuaire des membres :