Marie LEBARBIER

En résumé

Entreprises

• Laboratoires Majorelle - Pharmacien Responsable Intérimaire

  2017 - maintenant

• Laboratoires Majorelle - Pharmacien Affaires Réglementaires et Pharmaceutiques

  2014 - maintenant

• Mylan - Central regulatory affairs (EMA)

  SAINT PRIEST Cedex 2014 - 2014

• Chugai Pharma France - Pharmacist, RA & QA

  2012 - 2013 - Registration of a biotechnology product in France, Belgium et Luxembourg : MA variation, FUM, PSUR
  - Regulatory and competitive monitoring
  - Writing of internal procédures
  - Creation of internal formation tools
  - Regulatory compliance : following of batches and technical claims

• GlaxoSmithKline - Trainee, Worldwide Vaccine Registration

  Marly-le-Roi 2012 - 2012 - Country specific requirements coordination: coordination of the preparation of documents, samples, packaging components required for the registration, the submission of variations, Q&A at the international
  - Process Improvement: harmonisation of ways of working, creation of procedures

• CUSM McGill - Intern University Health Care

  2011 - 2011 - Prospective study of thromboprophylaxis at the MUHC.
  - Patient education

• Chugai Pharma France - Internship, Regulatory Affairs & Quality Insurance

  2011 - 2011 - RA: Regulatory compliance monitoring of promotional and environmental materials, creating a DMOS guide, regulatory and competitive monitoring, participation in the preparation of the certification audit of the hospital presentation of a drug, validating of DMOS record.
  - QA: Following of lots and technical claims, creating Quality documents (Quality Manual, procedure of notice update).
  - Belgium-Luxembourg: Writing procedures describing the business (management of samples, validation of promotional materials, and validation of donations).

• MUHC Nantes - Intern in Pharmacy, Nephrology-Immunology Dpt

  2010 - 2011 -Clinical Studies.
  -Therapeutic education.

• MUHC Nantes - Intern in Pharmacy, Laboratory management unit

  2010 - 2010 - Internal audit (ISO15189).
  - Pre-analytical process for laboratory analysis.

• In Cell Art - Intern, Regulatory Affairs and Quality Assurance

  2010 - 2010 - Determination of the non-clinical studies required before first clinical use of a gene therapy product
  - Creation of a quality system (ISO: 9001/2008)

Formations

• maintenant

• Université Paris-Sud 11

  Chatenay Malabry 2011 - 2012 International Drug Development and Registration

• Université Nantes

  Nantes 2007 - 2010

• Université Nantes

  Nantes 2006 - 2011 Pharmacie

Réseau

• Amélie SAUSSEREAU

• Anelis QUESADA

• Anne BOURCY

• Anne DROUET

• Cyrielle LEVY

• Laurie LE QUELLENEC

• Lucie DECAY

• Mathilde AUGER

• Mathilde FOLIARD

• William CHAUVIN