More than 560 hectares of land available to businesses Login Of In Fr Nl SPI Territory Infrastructure Services News Hurry Contact us Home → News → Agenda → Good morning Europe "Medical devices, how to fulfill your obligations in terms of clinical studies, pre and post market" Events Good morning Europe "Medical devices, how to fulfill your obligations in terms of clinical studies, pre and post market" November 19, 2014 11 SPI, Rue du Vertbois 4000 Liège " Medical devices, how to meet your obligations in terms of clinical studies, pre and post market " November 19, 2014 The notified bodies note an increase of the order of 50 to 60% of major non-conformities concerning clinical data. Indeed, even if the clinical studies have always been present in the legislation, the industry is today faced with more precise requirements and before which you, the manufacturer, you must face effectively in order to continue the marketing of your products. . Responses to non-conformities often involve painful choices such as reducing and / or changing the claims, fields of use of products in order to comply with the expectations of notified bodies. In addition, the duration for setting up and carrying out a post-market clinical study is variable. In most cases, these studies require more time than that allocated by the notified bodies. This is why, it is necessary to anticipate these major non-conformities. During this conference, in addition to an overview of regulatory changes concerning clinical studies relating to medical devices, keys will be presented to you in order to anticipate and / or react adequately to new situations: How to support your clinical bibliographic data? How to make up for clinical data that has become insufficient to keep your CE marking? Program : 1. Evaluation clinique : Panorama des changements 2. Les règlementations (2007, 2013 et MEDDEV) 3. Recueil des données cliniques 3.1. La littérature 3.2. Les expériences cliniques : Pré-market studies 3.3. Les investigations cliniques : Post Market Clinical Follow-up 4. Quelques clés... 5. CliniQual, la collecte facilitée des données cliniques Pour être le premier informé, inscrivez-vous rapidement pour venir écouter Françoise Schlemmer et Lorine Preud’homme. Françoise Schlemmer Son parcours : Après une licence en biochimie, elle a travaillé chez 2 Fabricants de dispositifs médicaux, puis un Organisme Notifié (auditeur IRCA pour ISO 9000, EN46000 & Directive 93/42/CEE). Aujourd’hui elle dirige la société Quasys Consult, active dans la Consultance en Management (spécialiste du marquage CE). Elle est aussi, depuis 2001, directeur de TEAM-NB - The European Association Medical devices – Notified Bodies. Lorine Preud'homme Son parcours : Licenciée en Sciences Biomédicales, spécialisée en Cosmétologie. Elle a travaillé dans la consultance réglementaire cosmétique. En rejoignant Quasys Consult, elle travaille ensuite comme consultante réglementaire dans le domaine des dispositifs médicaux incluant notamment les aspects cliniques. Inscription indispensable pour le 17 novembre 2017 en cliquant ici Participation : 48,40 EUR TVAC par personne à verser sur le compte n° BE46 0910 0078 6436 de la SPI avec mention « Nom du participant – nom société - Séminaire Dispositifs médicaux du 19/11/14». Toute annulation ne sera prise en compte que si elle est transmise par fax ou courriel au plus tard 24 heures avant la conférence. Otherwise, the registration fee will not be refunded. It is possible to be validly replaced by any other person. We reserve the right to cancel the conference in the event of insufficient participation and we undertake to notify participants as soon as possible. Contact: Philippe PARTOUNE Legal Advisor Project Manager Enterprise Europe Network European IPR Helpdesk Ambassador Trademark & Design Attorney philippe.partoune@spi.be - Tel .: +32 4 230 12 72 View all events © 2011 SPI Private life Terms of use charter Made by Visible