ComplianceOnline

EU Medical Device Changing Regulatory Landscape; 2010 Changes Now and What Current Re-writes Hold for 2011-12

Instructor: Robert J Russell
Product ID: 701805
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In this EU Medical Device EU Medical Device get a detailed understanding of 2009-2010 changing requirements for developing and marketing Medical Devices in the European Union and the future effects of current changes in MDD and CE marking registration system.

Why Should You Attend:

Upon completion of this webinar attendees will have a thorough knowledge of the 2009-2010 changing requirements for developing and marketing Medical Devices in the European Union. In addition, the Medical Device Directives and CE Marking Registration system is currently undergoing another major overhaul by the European Commission. We will focus on the current and predicted future requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the likely new requirements of CE Marking and ISO Certification on commercializing Devices.

Attend this webinar to learn the problems that exist with the current EU system and the options that the Commission is considering as they re-write the New Legislation which is scheduled to surface in late 2010 or early 2011. The course covers all relevant topics associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Areas Covered in the Seminar:

  • The purpose of the Medical Device Directives.
  • The current regulatory situation in relation to Medical Devices in the EU and the changes coming into force in 2010 from Directive 2007 / 47 / EC.
  • 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.
  • The current EU challenges with the CE Marking process, Auditing by Notified Bodies and Under-reporting of Device Adverse Events.
  • The Options the European Commission have to fix the current Problems.
  • Feedback the Commission has received from Stakeholders.
  • What this feedback likely means for future Directive changes and Member State Legislation.

Who Will Benefit:

This webinar 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:

  • 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
  • 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 countries)

Instructor Profile:

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 M.S.in Chemistry.

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