Publié le 08/10/2019
Cette formation vous est proposée par le Pôle des Microtechniques et son cluster Innov'Health, avec Neighborhood, le centre d’innovation de Voisin Consulting Life Sciences.
Inscription en ligne jusqu'au 15/01 sur la billetterie dédiée
Intervenants : Christophe Amiel et Slimane Oubaiche
Durant cette session plénière les sujets suivants seront abordés :
- Interactions avec les autorités de santé
- Passerelles réglementaires du marquage CE à la Clearance FDA
- Stratégie de développement clinique
- Ingénierie logicielle sous référentiel IEC62304
Intervenant : Slimane Oubaiche
Le but de cet atelier est d’explorer les processus qui dirigent le développement de dispositifs médicaux logiciels dans un environnement réglementé large, complexe et pas toujours à la portée des développeurs. Nous aborderons notamment les exigences des logiciels sous statuts de dispositif médical avec des cas pratiques et le retour d’expérience des participants. Enfin, un focus sera réalisé sur les spécificités liées à la cybersécurité, l'IA et le cycle de vie du développement agile, mises en perspective des référentiels CEI62304, IEC62366, ISO14971 et ISO13485 MD
Intervenant : Waiss Faissal
Ces deux aspects primordiaux du dossier technique figurent parmi les exigences réglementaires de plus en plus challengées lors des revues réglementaires. Une méthodologie robuste est la clef du succès d’une validation complète, mais qui pourrait être déclinée selon différentes perspectives que nous vous proposons d’aborder dans ce workshop.
Intervenant : Emmanuel Prades
Au cours de cet atelier différentes questions seront abordées :
- Les études cliniques étapes indispensable pour l’obtention d’une mise sur le marché ?
- Quels choix de revendications de performances cliniques pour un logiciel ?
Intervenant : Christophe Amiel
Au cours de cet atelier différentes questions seront abordées :
- Procédures d'enregistrement pour l'Europe et les US: quelles sont les différences majeures?
- Monter une stratégie des deux côtés de l’atlantique : Comment capitaliser sur les efforts règlementaires entre EU et US.
- Nouvelle Réglementation : quels Impacts sur les délais de commercialisation ?
Christophe Amiel, M.Sc.
As a Senior Director at VCLS, Christophe is responsible for leading the Medical Device and Digital Life Science Group. The Group specializes in providing advice to manufacturers of digital health technologies and ground-breaking medical devices on the design and implementation of international regulatory strategies, from an early stage of development through to market access.
Christophe has specific expertise in anticipating the regulatory and practical challenges frequently associated with innovative systems such as breakthrough digital technologies. This expertise encompasses e-health/m-health products, drug-device combinations and in vitro diagnostics. He is also responsible for the review and submission of regulatory applications in Europe and the US, including dossiers to support CE marking, 510(k)/DeNovo/PMA and Pre-market approval, and in leading interactions with multiple regulatory bodies (e.g. Notified Bodies and National Health Competent Authorities).
Christophe brings to the role more than 20 years of medtech experience, having worked in both SMEs and large international firms, such as Boston Scientific. During this time, he gained significant experience in the active medical device industry, in particular in next-generation implantable stimulators for neurological diseases (pelvic nerve stimulation for incontinence and spinal nerve stimulation for chronic headache). He was also responsibile for the management of international proof of concept clinical trials across Europe for a wide range of innovative therapeutic indications and advanced neuroprosthetic devices in the areas of pain management and pelvic health.
Christophe began his career in 1998 at Advanced Bionics in its auditory division, working as a clinical specialist. Whilst there, he acquired an in-depth knowledge of auditory nerve stimulation to treat profound deafness. In particular, he was responsible for assisting operating theatre staff during surgical procedures and providing expertise on related products to practitioners to support post-operative programming visits with patients.
Christophe earned his Master of Science in biomedical engineering from the University of Technology of Compiègne (UTC), France, and he holds a Bachelors degree in biomedical science from the University of Toulouse, France.
Michaël has more than 25 years of experience in the development and regulations of innovative software medical device.
Recently Michael Auffret served as Chief Product Officer at Median Technologies and was in charge of the development of a radiomics platform intended to identify new imaging biomarkers for liver disease (NASH, liver cancer) thanks to artificial intelligence technologies. Previously, he was in charge of the product management group, regulatory affairs and business support. As Director Project Management at HealthCenter/Focus Imaging he was responsible for the definition and marketing of advanced medical imaging applications for nuclear cardiology.
Michael holds a bachelor’s degree in fundamental physics and a master’s degree in biomedical image processing from the University of Paris, France.
As a Senior Regulatory Scientist at Voisin Consulting Life Sciences, Waïss is responsible for providing advice on Medical Devices and Combination Products. He has an in-depth knowledge of the requirements of the new Medical Device Regulation (745/2017) and his role includes writing, reviewing and submitting the technical file to support CE marking (in Europe) and market authorization approval in other markets (USA).
Waïss brings to the position expertise in a wide variety of certification schemes (ISO 13485:2016, ISO 9001:2015, CE Marking) and across different regulatory domains (Directives 93/42/EEC, 98/79/EC and 2001/83/EC, covering medical devices with an ancillary medicinal substance).
Waïss has significant experience of the “Medical Device Single Audit Program” (MDSAP) and has given training on this subject. His experience also covers Post Market Surveillance (PMS), Clinical Evaluation and Clinical Investigation data collection and reporting.
Before joining VCLS, Waïss worked as a Certification Project Manager, Drug Usefulness Subject Matter Expert and MDSAP Expert in the GMED North America, and as a Regulatory Affairs and Clinical Studies Manager in the Medical Device Industry, for a company specialized in orthopedic implant devices.
Waïss graduated from the University of Paris Sud, as Doctor of Pharmacy and has completed a Biomedical Engineering Master Program at the Engineering School of l’Ecole Normale Supérieure des Arts et Métiers (Paris, France).
Waïss is based in France, in the Paris office.
Emmanuel Prades, M.Sc.
Heading the clinical trial submission and oprations team, Emmanuel provide 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 a 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 programs 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 meeting, 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 activity 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 with the Livanova (Sorin Group) as clinical project manager, clinical trial manager and most recently as a senior clinical specialist, where he lead the complete management of international clinical studies. He has also worked with Laboratoire THERAMEX as an international clinical trial coordinator.
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.