Overview: This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic medical devices and active implantable medical devices. This webinar is further intended to provide guidance on the regulatory requirements set forth in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.

Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the EU market faster.

This webinar will discuss EU Directives, requirements and compliance. At the end of the webinar, you will get familiarized with the applicable EU Directives and CE marking process.

This webinar will help you profoundly change your way of regulatory and quality planning, development, and execution.

Why should you attend : To place your medical device products on the EU market, they must meet the requirements set forth in the applicable Directives.

This webinar will walk you through to help you understand the EU regulations governing medical devices including active implantable medical devices and in vitro diagnostic medical devices.

If you are engaged in global marketing of your medical products in EU, it is a must to attend this webinar.

Areas Covered in the Session
How EU laws are made
Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD)
In Vitro Diagnostic Device Directive (IVDD)
The directive amending MDD and AIMDD
CE marking principles
ISO 13485, ISO 14155, and ISO 14971
GHTF and MEDDEV guidance documents

Who Will Benefit:
Regulatory Affairs Managers, Directors and VPs
Clinical Affairs Managers, Directors and VPs
Quality Managers, Directors and VPs
Quality Managers, Directors and VPs
Compliance Managers and Directors
Sales and Marketing Managers, Directors, and VPs
Complaint Handling and Risk Management Managers and Directors
Site Managers, Directors, and Consultants
Senior and Executive Management
Compliance Officers and Legal Counsel
Business Development Managers, Directors, and VPs

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

This Medical Device Directive training will discuss 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.

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 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.

Learning Objectives:

Upon completion of this course, attendees will have a thorough knowledge of the ever-changing landscape to the EU Medical Device Directives 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 current requirements and to provide attendees with the latest insight to what the Commission believe are areas for improvement and what structure and requirements are likely to change.

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:
Scope of application and definition
Essential Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Clinical Evaluations
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
Standard
Active Implanted
In Vitro Diagnostic
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.
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), Combination Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
Guidance Documents.
Medical Device Directive Annexes.
Compliance Requirements by Type
Full Quality Assurance System
Declaration of Conformity
Safety.
Medical Device Vigilance System
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
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
Compare & Contrast EU & FDA Procedures and Requirements.
Process Similarities & Differences
Implications for Industry
Company Management
Process Changes
Management Team Effectiveness
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)

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 M.S.in Chemistry.

Why You Should Attend:

Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.

This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data - methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance - this webinar will share some tips and provide experience in this area.

Areas Covered in the Seminar:

Device classification distinctions, and what that means to you in terms of compliance burden.
Technical File contents and organization.
Review and selection of your notified body.
How to show compliance with the Essential Requirements.
Changes to MDD and their implications.
What is expected for clinical data.

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