Hélène CASAERT

En résumé

Entreprises

• European Medicines Agency, London, UK - Trainee scientific administrator

  maintenant 9 month Traineeship in the Human Unit – Special Medicines Department – Small and Medium Enterprises Office (SME Office):
  
  - Regulatory advice and administrative assistance to SMEs
  - Evaluation of SME status applications
  - Development of a public database of SMEs
  - Update of an userguide on the regulation of medicines in the European Union addressed to SMEs

• Boehringer - Ingelheim France, Paris, France - Trainee drug regulatory officer

  maintenant 6 month Traineeship in the Regulatory Affairs Department:
  
  - French registration activities,
  - Submission of Clinical Trial Application to Health Authorities,
  - Control of advertising and promotion of OTC medicines.

• Boehringer Ingelheim - Drug regulatory officer

  Paris Cedex 13 2012 - maintenant Drug regulatory officer in charge of clinical trials applications and registration activities (national products / centralized products).
  Therapeutic area : neurology - virology

• ANSM French health product agency - Scientific administrator

  2011 - 2011 clinical trials applications coordinator
  hospital preparation assessor

• Servier headquarter, Paris, France - Drug regulatory officer

  2010 - 2010 Drug regulatory officer / French Regulatory Affairs Department:
  - Registration for the pharmacovigilance activities in France: PSUR submission, Risk Management Plan follow-up, benefit-risk assessment dossiers, contact with the French health products safety agency
  - Management of the importation authorisations activity

• EMA European Medicines Agency - Scientific administrator - SME office - trainee

  2009 - 2010

• AFSSAPS, French health products safety agency, Saint-Denis, France - Trainee scientific administrator

  2007 - 2007 3 month traineeship in the Evaluation of Medicines and Biological Products Direction - Clinical trials and special medicines Department - Hospital Preparations Unit:
  
  --> Activities related to the assessment of the quality, safety and efficacy of hospital preparations in France

Formations

Pas de formation renseignée

Réseau

• Charlène FERRAND

• Danielle LAPORTE

• Edouard PRÉVOST

• Elodie DUVINAGE

• Laurent DEMAREST

• Linda CARDO

• Stéphane AUVIN