{"id":2178,"date":"2016-02-18T13:28:40","date_gmt":"2016-02-18T12:28:40","guid":{"rendered":"https:\/\/mcamps.com\/?p=2178"},"modified":"2016-02-23T15:46:59","modified_gmt":"2016-02-23T14:46:59","slug":"apostamos-por-la-formacion-gtf-organiza-un-curso-sobre-el-nuevo-reglamento-europeo-de-ps","status":"publish","type":"post","link":"https:\/\/mcamps.com\/eng\/apostamos-por-la-formacion-gtf-organiza-un-curso-sobre-el-nuevo-reglamento-europeo-de-ps\/","title":{"rendered":"We are committed to training: GTF is organising a course on the new European PS regulation."},"content":{"rendered":"

Since 2012, the EU has been working on improving and modernising the European directives for Medical devices<\/strong> and in vitro diagnostic medical devices. At the beginning of last year, a first draft appeared that has been consolidated in recent months, and the new PS Regulation is expected to be approved during the Dutch presidency of the EU, i.e. during the first half of 2016. On the occasion of this imminent change in the European legal framework on PS, next Tuesday 15 March Merc\u00e8 Camps<\/strong> will coordinate the course New European regulation on medical devices<\/em><\/strong>, which will be held in IL3<\/strong>, The UB's Institute for Lifelong Learning.<\/p>\n

The teaching staff of the training course will include a number of high-level professionals from the sector: Carmen Abad<\/strong>, Head of the Department of Medical Devices of the AEMPS<\/strong>, \u00a0Mar\u00eda Al\u00e1ez<\/strong>, Technical Director of FENIN<\/strong>, Anna Amich<\/strong>, Manager Surgical Safety Operations of Alcon<\/strong>, Maite L\u00f3pez-Gil<\/strong>, Deputy Technical Director of the ANEFP<\/strong>, Tomassi Rosso<\/strong>, Team Leader for Medical Devices at Kiwa Cermet<\/strong> y Maria Concepci\u00f3n Rodr\u00edguez Mateos<\/strong>, Head of the Clinical Research Service with PS of the AEMPS<\/strong>.<\/p>\n

The course is aimed at general managers and technicians of PS manufacturing\/marketing companies in the areas of Registration, Production, Quality and Sales. We hope you find this training offer interesting, and we remind you that you can register today at this link<\/a>. Do not hesitate to contact us at gtf@mcamps.com<\/a> or consult the website if you need more information about the course.<\/p>\n

\n

 <\/p>\n

Programme<\/strong><\/h3>\n

9.00-9.15h. Collection of documentation and presentation of the course.\u00a0Merc\u00e8 Camps<\/em><\/p>\n

9.15-10.45h.\u00a0General Aspects of the new Medical Devices Regulation<\/strong>.Carmen Abad (AEMPS)<\/em><\/p>\n

10.45-11.15h. Coffee Break<\/p>\n

11.15-12.00h.\u00a0New Classification Rules<\/strong>.\u00a0Maria<\/em>\u00a0Alaez (FENIN)<\/em><\/p>\n

12.00-12.45h.\u00a0Clinical aspects of the new Regulation<\/strong>\u00a0(to be determined).\u00a0Maria Concepci\u00f3n Rodr\u00edguez (AEMPS)<\/em><\/p>\n

12.45- 13.30h.\u00a0Surveillance and Post-Marketing from the new Regulation<\/strong>.Anna Amich (ALCON)<\/em><\/p>\n

13.30-15.00h. Lunch<\/p>\n

15.00-16.00h.\u00a0Labelling and Advertising of Medical Devices<\/strong>.\u00a0Maite L\u00f3pez-Gil (ANEFP)<\/em><\/p>\n

16.00-17.00h.\u00a0EUDAMED and UDI (Unique Product Designation) database according to the New Regulation<\/strong>.\u00a0Fabio Tommasi Rosso (KIWA CERMET)<\/em><\/p>\n

17.00-18.00h. Round Table\/ Conclusions<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

Desde 2012 la UE est\u00e1 trabajando en la mejora y modernizaci\u00f3n de las directivas europeas de Productos Sanitarios y de Productos Sanitarios de diagn\u00f3stico in vitro. A principios del a\u00f1o pasado, apareci\u00f3 un primer borrador que se ha ido consolidando en los \u00faltimos meses, y previsiblemente, el nuevo Reglamento de PS se aprobar\u00e1 a lo […]<\/p>\n","protected":false},"author":1,"featured_media":2180,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[301,199],"tags":[303,305,287,185,307,157],"class_list":["post-2178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formacion","category-productos-sanitarios","tag-formacion","tag-il3","tag-productos-sanitarios","tag-reglamento","tag-ub","tag-ue"],"_links":{"self":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts\/2178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/comments?post=2178"}],"version-history":[{"count":0,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/posts\/2178\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/media\/2180"}],"wp:attachment":[{"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/media?parent=2178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/categories?post=2178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcamps.com\/eng\/wp-json\/wp\/v2\/tags?post=2178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}