Since 2012, the EU has been working on improving and modernising the European directives for Medical devices 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 Mercè Camps will coordinate the course New European regulation on medical devices, which will be held in IL3, The UB's Institute for Lifelong Learning.
The teaching staff of the training course will include a number of high-level professionals from the sector: Carmen Abad, Head of the Department of Medical Devices of the AEMPS, María Aláez, Technical Director of FENIN, Anna Amich, Manager Surgical Safety Operations of Alcon, Maite López-Gil, Deputy Technical Director of the ANEFP, Tomassi Rosso, Team Leader for Medical Devices at Kiwa Cermet y Maria Concepción Rodríguez Mateos, Head of the Clinical Research Service with PS of the AEMPS.
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. Do not hesitate to contact us at gtf@mcamps.com or consult the website if you need more information about the course.
Programme
9.00-9.15h. Collection of documentation and presentation of the course. Mercè Camps
9.15-10.45h. General Aspects of the new Medical Devices Regulation.Carmen Abad (AEMPS)
10.45-11.15h. Coffee Break
11.15-12.00h. New Classification Rules. Maria Alaez (FENIN)
12.00-12.45h. Clinical aspects of the new Regulation (to be determined). Maria Concepción Rodríguez (AEMPS)
12.45- 13.30h. Surveillance and Post-Marketing from the new Regulation.Anna Amich (ALCON)
13.30-15.00h. Lunch
15.00-16.00h. Labelling and Advertising of Medical Devices. Maite López-Gil (ANEFP)
16.00-17.00h. EUDAMED and UDI (Unique Product Designation) database according to the New Regulation. Fabio Tommasi Rosso (KIWA CERMET)
17.00-18.00h. Round Table/ Conclusions