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Live Webinar on : Medical Devices: EU Directives, Guidance Documents, CE Marking

Process and ISO Certification Programs Monday, June 04, 2012 duration : 01:00 to 02:30 PM EST


Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

Who will benefit

This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation. Areas Covered in the Session:

Clinical research and medical operations Project Managers Product Development personnel Manufacturing personnel Researchers managing Medical Device R&D and Development Quality Assurance such as GMP, GCP Auditors Regulatory affairs

- The current regulatory situation in relation to Medical Devices in the EU. The purpose of the Medical Device Directives. Meeting the New Requirements for Conformity Assessment by Product Type. Understanding the impact the Directive will have on developing and marketing new Medical Device products. An overview of key areas of the Directive: o Scope of application and definition o Essential Device Requirements o Medical Device Type & Process Path o Medical Device Technical File o Clinical Investigation Requirements

Clinical trial supply personnel CRO personnel

All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)

Clinical Evaluations Notified Bodies involvement Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
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. Learning Objectives
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations. Key Topics to be Discussed:


Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Get Training CD : $499

More Trainings

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About Speaker
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the

Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and Chemistry..
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