Florence Beytout

Florence Beytout

Senior Consultant, Regulatory Affairs and Intelligence

Contacter

Education

Florence earned her Pharm.D. degree from the University of Pharmacy in Clermont-Ferrand, France.

 

About Florence

Florence has been involved in various regulatory projects assisting start-up to international companies. Her recent client work includes:

 

  • Development activities: management of operational and strategic activities for CTAs (initial submission and follow-up). Florence worked for more than one year for one client based in France as Regulatory Affairs manager for CTAs as an actual team member. She acted as Global Regulatory Affairs representative in cross-functional study team meetings and provided required regulatory support to company’s functions.
  • Scientific writing activities including: Preparation or update of IMPDs, Investigator Brochures, clinical overviews, briefing packages for scientific advices (EU, US, JP), answer to questions from Health Authorities
  • Registration activities: Florence led new MAA applications both in national (FR) and EU procedures (MRP, DCP and centralized procedures), advice on registration strategies

Florence has recently enlarged her responsibilities by overseeing Regulatory intelligence at Bluereg. She is actively ensuring the up-to-date internal knowledge of Bluereg consultants by providing routinely latest regulatory news and providing highlights or training on specific regulatory topics or novel legislation. She is also supporting consultants by providing regulatory analysis on client’s specific request. 

 

Background / Past experience

Prior to joining Bluereg, Florence worked for several companies in Paris, in the UK and in the South of France. During her past positions, Florence has been covering a wide range of regulatory activities for registration of medicines in France and EU.  She has also covered other activities including registration of medicines and devices in Asian and Maghreb countries, control of promotional materials for FR and UK market, due diligences. She has also been involved in pharmacovigilance activities.

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