Live Webinar
on
Changes in the EU Medical Device Directives; 2010 Modifications and the 2012 Recast of the MDD Directives
Date & Time: Tuesday, March 13, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Robert J. Russell
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: 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. This Medical Device Directive training will be discussing the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.
Areas Covered in the Session: l l
Definition: Medical Device or Personal Protective Equipment. Overview of Global Medical Device Industry ¡ ¡ ¡ ¡
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Directives An Overview of the Medical Device Directives. ¡ Development, aims, implementation and update of the ¡ ¡
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Standard Active Implanted In Vitro Diagnostic Combined Medicinal / Device- Interface with Other
Medical Device Directives Implication of an EU Directive vs. Regulation Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combined Medicinal / Medical Device Products Update on the additional guidance documents relating to the directives Essential Requirements Classification of MD's and Process Implications / Path by Device Type Conformity Assessment Technical File
¡ Relationship to EU Clinical Trial Directive 2009-2010 Changes from Directive 2007 / 47 / EC Current Perceived Problems (by the Commission) with the Current CE Marking Registration System and Notified Body
Auditing Structure Correction Options Laid Out by the European Commission Feedback Received from Stakeholders
Click here to register for this webinar Who Will Benefit: l l l l l l
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
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Regulatory affairs Clinical trial supply personnel CRO personnel
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All personnel who need to understand the procedures and
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Robert J. Russell President, RJR Consulting, Inc For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. ...more
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impact of placing Medical Devices on the Market across the EU
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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