Gaëlle has over 15 years of experience in Regulatory Science in the biopharmaceutical industry and in consulting for various types of products (drugs, biologics, advanced therapy medicinal products), therapeutic areas and trial phases, from first-in-human studies to confirmatory phase III trials. She provides strategic advice and regulatory oversight of clinical trials, managing submissions to competent authorities, ethics committees and other regulatory bodies both in Europe and in other regions.
Gaëlle provides expertise during public consultations on draft essential clinical trials regulatory documents as published by international regulators and assists our clients in preparing for the EU Clinical Trials Regulation.
She has responsibility for the review of core study documents, (e.g., protocol, investigator’s brochure [IB], labels and patient information leaflets – informed consent forms), together with the preparation and/or review of all other documents in accordance with local requirements.
Prior to joining VCLS, Gaëlle worked in the Biopharmaceutical Industry, as a Worldwide Regulatory Strategist, in charge of clinical trial activities, clinical development plan, conduct of European and US scientific advice procedures including the authoring of briefing documents, orphan drug designation (ODD) applications, as well as in the preparation of Paediatric Investigation Plans (PIP).
During her employment at a large French Pharmaceutical company, she gained significant experience in clinical trials, post marketing activities in the US and Japan, and supporting the internal implementation of the EU pediatric regulation.
Gaëlle is a pharmacist by training and graduated in 2006 with a master’s degree in Pharmaceutical Regulation (Strasbourg – France),
In addition to French, her mother tongue, Gaëlle speaks English, and has a basic knowledge of German.
Gaëlle is based in Switzerland.
