Agathe DAUBISSE

Senior Regulatory Affairs Advisor

PhD in Pharmacy
Master's degree in Regulatory Affairs for Health Industries (ARIS)

Agathe began her career as a Regulatory Affairs Pharmacist specialising in human plasma-derived medicinal products at LFB BIOMEDICAMENTS. There, she gained valuable experience in preparing submissions for new marketing authorisation applications in Europe and maintaining marketing authorisations in collaboration with the health authorities.

Her career then took her to the French subsidiary of Bayer Laboratories. There, she managed not only registration activities, but also those linked to drug promotion and communication. Her experience was further enriched at Bayer, where she contributed to the international registration strategy for major products, interacting closely with the health authorities. Agathe played a key role in the launch of new products on the European markets and worked on a variety of subjects ranging from pharmacovigilance to clinical studies. More recently, at Theravia, Agathe has broadened her skills, taking charge of the international registration of products with Orphan Drug status.

Agathe joined ATESSIA in March 2024.

Expertise

Exploitant

Clinical development / Scientific advice

Regulatory strategy

EU registration

Early access

External communications compliance