Regulatory Clinical Trials
Cécile Henrot specializes in clinical trials within VCLS. As a project manager and advisor, she oversees the studies from a regulatory point of view and manages the submissions to European competent authorities, ethics committees and other regulatory bodies as appropriate, such as regional authorities and data protection committees.
Prior to the clinical trial application submission, she is involved in the review of the study core documents, such as the protocol, investigator’s brochure (IB), labels and patient information leaflets – informed consent forms, and the preparation and/or review of all other necessary documents in accordance with local requirements. Following the clinical trial authorization, she prepares and submits the necessary notifications until the clinical study report, including any applicable substantial amendments.
During the course of the study, she is responsible for following up the applications in close contact with the concerned bodies, and ensures appropriate tracking and timely communication with the sponsors and associated partners (e.g. CROs/CRAs). She collaborates with the pharmacovigilance team to identify any impact of the safety reporting on the regulatory activities, and with the other regulatory teams (Scientific Advice, PIP, MAA…) to ensure consistency of the applications. Finally, she provides the sponsors with ad hoc advice regarding European, national and local requirements and compliance with good clinical practices (GCP).
Cécile has experience with various types of products (in particular drugs, biologics and gene therapy/genetically modified organisms) and trial phases, from first-in-human studies to confirmatory phase III trials. She also has significant experience in the submission of multinational clinical trials via the Voluntary Harmonisation Procedure (VHP).
Cécile is actively involved in the development and update of regulatory tools and templates for clinical trial activities, and performs a continued regulatory surveillance linked to clinical trials and other areas of interest for the company. She prepares or reviews Quality Assurance documents, in particular GCP Distinct Technical Procedures, and has been responsible for several internal trainings in clinical trial management. Within VCLS, she responded to public consultations aiming to assess the functioning of essential clinical trials regulatory documents, and has been involved in the discussions surrounding the new Clinical Trials Regulation.
In addition, Cécile has significant expertise in biobanking regulations, particularly in France, and in data protection regulations, within and outside the clinical trial area. She also gained substantial experience in life cycle management for conetralised procedures, orphan drug designation applications and paediatric investigational plan activities.
Cécile graduated from the engineering school Institut National des Sciences Appliquées (National Institute of Applied Sciences) in Lyon, France, where she earned a Master’s Degree in Biochemistry and Biotechnologies. She has been working for VCLS since February 2009, and has successfully passed and renewed her GCP certification. In addition to French, her mother tongue, Cécile speaks English and German, and has a basic knowledge of Spanish.