2011 - Webcast on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs by compliance2go

Why Should You Attend: 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.

Key Topics to be Discussed:
? 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
o Clinical Evaluations
o Notified Bodies involvement
? Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

Detailed Agenda of the Session:
? Definition: Medical Device or Personal Protective Equipment.
? Overview of the Global Medical Device Industry
o Standard
o Active Implanted
o In Vitro Diagnostic
o Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective
? An Overview of the Medical Device Directives.
o Development, aims, implementation and update of the Medical Device Directives
o Implication of an EU Directive vs. Regulation
o Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products
o Update on the additional guidance documents relating to the directives
o Essential Requirements
o Classification of MD's and Process Implications
o Conformity Assessment
o Technical File
o Relationship to EU Clinical Trial Directive
? Guidance Documents.
? Medical Device Directive Annexes.
o Compliance Requirements by Type
o Full Quality Assurance System
o Declaration of Conformity
? Safety.
o Medical Device Vigilance System
o Manufacturer's Requirements
? GMP
? GCP
CE Marking
ISO Certification
Clinical Trials
Labeling
ISO Standard Certification.
Overall process; Management Commitment & Involvement
Role of Notified Bodies
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
o ISO-14155 Medical Device Clinical Investigations.
? Part I- Clinical Studies
? Part II- Clinical Investigations
? Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
o Compare & Contrast EU & FDA Procedures and Requirements.
? Process Similarities & Differences
o Implications for Industry
? Company Management
? Process Changes
? Management Team Effectiveness
o Regulatory Approval and Liaison with Regulators.
? EU Co-Decision Procedure
? Committees, Working Parties Relevant for Medical Devices
? When and How to Influence Regulators
? Do's and Don'ts of Regulatory Involvement
? Individual Company Involvement vs. Trade Association

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.

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:
? 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 EEA countries)

bout the 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 M.S.in Chemistry.

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