Clinical Research and Medical Operations
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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
Pricing
Live ( Single registration ) :$189.00
Group ( Max 10 Attendee):$249.00 On Demand (Recording available):$289 Get Training CD : $499
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/ Description
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.
Areas Covered in the Session:
- - 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.
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.
Key Topics to be Discussed:
In 2010 under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, Site and IRB Inspections. Of those Inspections 9% or ~ 66 of the Clinical Investigator Inspections, 6% or ~ 15 of the IRB Inspections and 12% or ~ 15 of the Sponsor/Monitor Inspections were categorized as "Official Action Indicated". 45% of Clinical Investigator, 50% of IRB and 38% of Sponsor/Monitor Inspections were categorized as "Voluntary Action Indicated" being required. Because FDA Inspections are part of doing business and getting products to market, Clinical Investigators, Sponsors and IRBs should not only be prepared to handle an FDA Inspection but also be prepared to follow-up on findings, following the inspection.
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..
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