Heading the clinical trial submission and operations team, Emmanuel provides technical expertise in clinical project management and strategy as well as regulatory support for clinical study submission.
With over 20 years in Clinical development in diverse areas from pharmaceutical to medical device industry, Emmanuel has broad technical expertise in clinical trial regulations and associated country-specific requirements and has extensive experience in various trial phases, product types, indications, and geographical areas. As Eucomed Members from 2008 to 2016, Emmanuel was highly involved in the evolution of the Medical Device Regulation and preparation of the new EUDAMED portal from a clinical study and vigilance point of view.
As a Project Manager, he supervised clinical program design and implementation including the preparation of the core documents (protocol, Investigator’s Brochure, etc.), and study regulatory set-up and management from the clinical trial application (CTA) to the submission to both Competent Authorities and Ethics Committees. The management of large complex projects gives him the opportunity to actively interact with the different departments within the study sponsors. He has worked on investigator meetings, initiation, steering, or adjudication board management and the elaboration and management of the vigilance activities for the clinical point of view as a compliance safety officer. He has experience working with CRO’s, central lab selection and management, CRA and clinical project assistant management, SOP writing, and field clinical team activity coordination.
He has extensive experience in strategic clinical decision meetings with various cross-functional activities for regulatory, safety, quality, and study organization. He also has experience in quality as a clinical QA advisor (audit, SOP writing, Team training).
Prior to joining VCLS, Emmanuel worked 12 years with the Livanova (Sorin Group) as a clinical project manager, clinical trial manager, and most recently as a senior clinical specialist, where he lead the complete management of international clinical studies in interventional cardiology. He has also worked with Laboratoire THERAMEX as an international clinical trial coordinator (woman health).
Emmanuel is an engineer in biotechnology from the E.S.B.S. (Ecole Supérieure de Biotechnologie de Strasbourg) and earned a Master’s degree in molecular and cell biology.
Emmanuel Prades is based in our Paris office.