Clotilde Picard

Coordinate and execute registration in line with business needs Asses new registration opportunities EU MDR and IVDR implementation, Gap analysis Regulatory support: vigilance reports, new product request, customer inquiry ISO 9001 internal auditor

EU Regulatory Officer Rare Diseases, Rare Blood Disorders: Coordinate and Execute :

•EU strategy from FIH to MAA

•CTA, VHP

•EMA Scientific Advice, Innovative Task Force

•Paediatric Investigational Plan (PIP)

•Orphan Drug Designation

Homeopathic company

•CMC : Medical writing (update of module 2 to 4) in the scope of the Italian validation

•International registration : Romania, Morocco, Tunisia, Belgium, France Country focal point, Regulatory strategy and planning, variation, new registration, responses to deficiency letters