GlobalCompliancePanel, Online Training
2012-03-13
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.
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:
- Scope of application and definition
- Essential Requirements
- Medical Device Type & Process Path
- Medical Device Technical File
- Clinical Investigations
- Clinical Evaluations
- Notified Bodies
- 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 Global Medical Device Industry
- Standard
- Active Implanted
- In Vitro Diagnostic
- Combined Medicinal / Device- Interface with Other Directives
- An Overview of the Medical Device Directives.
- Development, aims, implementation and update of the 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
Who will benefit:- 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 across the EU
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Invited Speakers:
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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.
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