Delphine Kazancigil is Director in VCLS’s office in Paris. She is an experienced regulatory science professional who has an in-depth knowledge of the European (EU) legislation and regulatory requirements.
Delphine assists clients with her scientific, technical and regulatory expertise in the design of products development plans and associated regulatory and registration strategies. In particular, she has significant experience in writing pediatric investigational plans (PIP), including recommendations on the design of the PIP and in writing orphan drug designation (ODD) applications in the EU. She also has extensive experience with national and European scientific advice procedures. She is experienced in the life cycle management of medicinal products authorized in the EU. She is also involved in the management of worldwide clinical trials regulatory applications and the preparation of marketing authorization submissions in the EU.
Through her professional experience, Delphine worked on the development and registration of drugs and innovative investigational products at all stages of clinical development and in different therapeutic areas such as oncology, ophthalmology, neurology and anti-thrombotic.
Delphine is a Doctor in Pharmacy specialized in regulatory science with an M.Sc. program in international drug development and registration, earned at the University of Paris XI.
Delphine gained more than 10-years experience in the pharmaceutical industry, working as regulatory science project manager within international and multidisciplinary project teams. She spent more than 4 years in the UK, working in the European Headquarters of several American companies specialized in small molecules and biotech products. Prior to joining VCLS, Delphine worked for 4 years in the global headquarters of a large French company where she gained significant experience in the design and implementation of regulatory strategies in Europe, US and worldwide.