Elodie Soude

Elodie Soude

Regulatory Affairs Consultant

Key Knowledge area

  • Pharmacovigilance
  • Medical Documentation and Information
  • CMC Documentation management
  • Regulatory review of Promotional materials 

Contacter

Education

DU in Quality Audit in the pharmaceutical industry – Paris Pharmacy University – 2010 

DU in Clinical Research – Bordeaux Medicine University – 2008 

DESS/Master degree Control of Drugs and Cosmetics – Reims Pharmacy University – 2005 

 

About Elodie 

Elodie has gained an extensive experience in Review of Promotional MaterialPharmacovigilance and CMC Regulatory Affairs after working for more than 12 years in the pharmaceutical industry. 

 

Elodie is a regulatory affairs consultant contributing to BlueReg regulatory expertise in the global development, registration and commercialisation of pharmaceutical products

 

Background/Previous experience 

She worked 5 years as Drug Safety Scientist in the Headquarter of Guerbet then in the French affiliate of Bayer Healthcare. Her job consisted in managing individual case safety reports (spontaneous and from clinical trials) in the database. She also wrote a PSUR and SOPs for the Pharmacovigilance department. 

 

For Bayer Healthcare, she was in charge of monitoring scientific literature to make a press review and bibliographic researches. In this position, she worked on the implementation of the medical information database IRMS in the French affiliate and trained the users. 

 

Since 2014, for Galderma laboratory, in the pharmaceutical development department, she managed the pharmaceutical documentation to help the scientific writer in preparing the CMC part of the dossier (IND, IMPD, CTD, NDA) and to facilitate the transfer of projects from R&D to plants. 

 

In September 2018, she joined BlueReg as Regulatory Affairs consultant. She provided support for regulatory strategy in product lifecycle management and she coordinates the regulatory review of promotional materials thorough Europe.