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Koussayla BOUKALFA

CAMBRIDGE

En résumé

Mes compétences :
Affaires réglementaires
Industrie pharmaceutique

Entreprises

  • Gilead Sciences - Regulatory Affairs - Emerging Markets

    2014 - maintenant Labelling Coordination and Project Management – Emerging Markets
    - Labelling update strategy within ROW regions according to internal and external factors
    - Liaising with Global labelling team and reference markets (EU and US)
    - Driving of labelling updates within LATAM region
    - Regulatory Affairs Intelligence for labelling/packaging
    - Linguistic support for ROW teams (French, Arabic, English and Spanish)
    Renewals and registration of the new products within Latin America
    - Preparation of the new MAA/NDA package
    - Creation of the local labelling for each market
    - Regulatory Intelligence within LATAM
    Implementation of New Packaging System within International Regulatory Affairs and Labelling Operations
    - Harmonization of packaging preparation processes within the regions
    - Implementation of regulatory requirements within the system
    - Validation of the new system before the go live
    - Creation of working instructions and procedures
    - Preparation of the training supports
    - Training of Regulatory Affairs teams

  • Sanofi Pasteur - International Regulatory Affairs (WHO, ANSM, FDA, EMA...)

    Lyon 2013 - 2014 - Creation of 3 WHO prequalification dossiers (Product Summary File) for 3 vaccines.
    - Preparation of PQVAR (Annual reports)
    - Preparation of PBRER.
    - Preparation of Product information for two vaccines.
    - Preparation of labeling variations.
    - Answer to questions for Quality and labeling variations.

  • Sanofi Pasteur MSD - Regulatory Affairs

    Paris 2013 - 2013 Preparation of variations dossiers, Annual variation of flu vaccines strains, Validation of the labeling and packaging materials, handling of PSUR and PBRER (European Procedures: CP, MRP, DCP and National Procedures)
     Preparation of Variations applications and tracking activities.
     Creation and modification of packaging materials.
     Management of Flu Packaging and the annual variation of flu vaccines strains (Special Procedure)

  • Sanofi Pasteur - Regulatory Affairs "Middle-East"

    Lyon 2012 - 2012 Preparation of Renewals and Variations Applications of Vaccines in the Middle-East Area
     Renewal of vaccines in Middle-East Area.
     Preparation of Variations applications and tracking activities.
     Establishment of regulatory strategies according to the business needs.

  • CRPV Lille - Pharmacovigilance

    2012 - 2012 Pharmacovigilance Activities (To ensure appropriate safety and security of medicines)
     Writing of answers to healthcare professionals.
     Writing of case reports.
     Registration of pharmacovigilance cases in the French National Database.

  • CHRU Lille-Pharmacy - Clinical Trial

    2011 - 2011 Setting up and Monitoring of Clinical Trials in the University Hospital Centre of Lille
     Meeting of setting up and monitoring of clinical trials with pharmaceutical companies managers.
     Writing of procedures for management of clinical trials protocols.
     Writing of technical data sheets.

  • Medicinal Chemistry Laboratory of Pharmaceutical Chemistry Institute Albert Lespagnol of Lille 2 Uni - Conception and synthesis of Donepezil analogues (ARICEPT) and Agomelatine

    2011 - 2011  Bibliographic research, conception and establishment of synthesis schemes.
     Quality control of synthetized products: CCM, HPLC, IR, RMN, LCMS & melting point
     Participation in publication of a scientific article : Novel Conformationally Constrained Analogues of Agomelatine as New Melatoninergic Ligands : http://www.mdpi.com/1420-3049/18/1/154

Formations

Réseau

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