Shayesteh is founder of SFL consulting located in Swiss and UK providing with her team comprehensive regulatory, legal, public affairs and communication support to life science companies. She is in Program Committee in Euromeeting 2011-2013 and chairs the Combination Product Group at EuropaBio.
Shayesteh is founder of SFL consulting located in Swiss and UK providing with her team comprehensive regulatory, legal, public affairs and communication support to life science companies. She is in Program Committee in Euromeeting 2011-2013 and chairs the Combination Product Group at EuropaBio.
Sunita Ahir, D-Target, a Premier Research Company, Switzerland
Dr Sunita Ahir is a Regulatory Affairs Manager at D-Target. Her role is to advise clients on all aspects of the CE marking process. She has extensive experience of medical devices having worked for BSi Healthcare as a technical expert reviewing Class IIb and III submissions.
Regina Freunscht worked in international clinical research for pharmaceutical companies and CROs in various positions since 1989. She works for Accovion, a European Full-Service CRO, as Director Marketing and Communications and is a member of the company's Management Team.
Ibim Tariah, BSI, United States
Description
This symposium will provide an overview of the latest development and EU Commission's proposals on the Revision of Medical Device Directives including In-Vitro Diagnostics Directive in comparison to the current legislation will be provided. Notified Body representative will analyze the impact of the revised legislation will have on the system of third party assessment in Europe; and highlight those elements changed in the supervision by the third parties on industry and other stakeholders as consequence of the revised legislation. Further, the impact of the revised legislation on the company procedures and strategy will be provided. Additionally, an overview on the current and future reporting of serious adverse events from medical device trials in Europe will be provided.
Learning Objectives: Discuss the EU Commission's proposals on the Review of Medical Device Directives Describe the revision of the In Vitro Diagnostic Directive comparison to the current legislation Identify the impact of the revised legislation on the system of third party assessment in Europe.