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Christel Daussogne

Associate Director, Global Regulatory Consulting at Syneos Health Consulting

Passionate by my work, motivated by patients’ care and driven by Sciences, I am continuously seeking ways to go further and propose alternative solutions. An example of my recent achievement was to propose and organise the 1st “Rare Disease Day” event at Galderma, for which I received a “Innovation award”. In this context, I invited a KoL (Dr BOURRAT) and 2 patients’ associations (“Association Ichthyose France” and “European Network for Ichthyosis”) to explain the disease and the patients’ needs. See https://www.ichtyose.fr/articles/24056-galderma-1er-disease-day Regulatory Affairs (RA) representative, responsible for all RA activities supporting international Rx drug development (Early & Full), including orphan products. - Provide RA guidance to Project Teams and contribute to the Global development plan of prescription drugs; - Gain all Phases WW clinical trials’ authorisations, Orphan Drug Designations, paediatric plans, ATC code, INN, Brand/Invented Names,… - Define the strategy for consultation and represent RA in meetings with Authority (FDA, EMA, PMDA); - Lead the WW registration strategy, eCTD preparation and insure on time submission; - Pilot the labelling preparation of Rx drugs : under development (TPP), when preparing the eCTD (USPI/SmPC & their consistency with Module 2) and post-marketing safety variations (revised Product Information & dossier). My added values are: - My global vision of drug development, gained from complementary experience in RA, Pharmacovigilance & Clinical Research, speeds up my ability to identify the critical points and to build strong synergic relationships with multidisciplinary experts. - My international experience, working in various organisations (blueship/start up pharma companies & CRO), proves my aptitude to quickly adapt and to lead & unite transcultural experts based remotely. Searching for an exciting opportunity, I am motivate to propose my technical & soft skills and my personality to manage your projects.

Contact Information

Personal Email
c*****@yahoo.fr
Location
France

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View Colleagues

John Cogan
John Cogan

Executive Managing Director & Global Practice Leader, R&D Advisory

Melissa Landers
Melissa Landers

Managing Director

Shahid Iquebal
Shahid Iquebal

Senior Analyst

Eric Choi
Eric Choi

Consultant

Frequently Asked Questions Regarding Christel Daussogne

What company does Christel Daussogne work for?
Christel Daussogne works for Syneos Health Consulting
What is Christel Daussogne’s role in Syneos Health Consulting?

Christel Daussogne's role in Syneos Health Consulting is Associate Director, Global Regulatory Consulting

Who are Christel Daussogne’s colleagues?

Christel Daussogne's colleagues are John Cogan, Melissa Landers, Shahid Iquebal, Eric Choi.