Regulatory Science, Clinical Trials
Delphine Decker plays a major role in Voisin Consulting Life Sciences (VCLS) activities related to Clinical Trials Application and Project Management. She has extensive experience in projects involving the design and implementation of regulatory strategies for the clinical development and registration of drugs and innovative medicinal products.
Delphine is responsible for the regulatory set-up and management of clinical trials, from the clinical trial application (CTA) to the submission of the clinical study report. She has a broad technical expertise in clinical trial regulations, including in the recent Voluntary Harmonized Procedure (VHP), and associated country-specific requirements, and has extensive experience in various trial phases, product types, indications and geographical areas. As a Project Manager, she leads the preparation of CTAs, including the writing and review of the study core documents (protocol, Investigator’s Brochure, Investigational Medicinal Product Dossier), and the preparation of all subsequent applications (e.g. amendments), for submission to both Competent Authorities and Ethics Committees.
Recently, Delphine’s broad expertise led her to manage large complex projects including for biological products, where she oversees clinical trials, scientific advice meetings and procedures, pediatric investigation plans and marketing authorization applications.
Delphine worked for two years as a Regulatory Affairs Manager for one of VCLS’ US clients affiliate based in France. In particular, she was in charge of the management of a pediatric clinical trial conducted in and outside Europe. This gave her the opportunity to actively interact with the different departments within the company, as well as with the regulatory teams of the Clinical Research Organizations involved in the study. She also participated in strategic clinical decision meetings.
In addition to clinical trials, Delphine has significant experience with the 1901/2006 Pediatric regulatory framework and participates in the design and preparation of Pediatric Investigation Plans. She also participates in the preparation of European and national scientific advice meetings and Centralized Marketing Authorization Applications.
Delphine earned a Masters in Healthcare Products and Services Policy at the University Paris 5. The curriculum included regulatory affairs, and legal and economic issues related to Healthcare. Delphine also completed a Masters in Innovation Management at “Ecole Supérieure d’Application des Biotechnologies – Paris La Defense”.
Prior to joining Voisin Consulting Life Sciences, Delphine worked as a scientific and regulatory analyst in a French gene therapy start-up for rare diseases.