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  1. 1. <ul><li>Live Webinar on : Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs - Tuesday, Oct 4 2011, 01:00 PM EST / 10:00 AM PDT (90 Minute)                     Get 15 % Discount as a early bird registrations. Use Promo Key :  CGO15 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 operationsProject ManagersProduct Development personnelManufacturing personnelResearchers managing Medical Device R&D and DevelopmentQuality Assurance such as GMP, GCP AuditorsRegulatory affairsClinical trial supply personnelCRO personnel:PricingLive ( Single registration ) : $189.00Group ( Max 10 Attendee): $499.00More Trainings                Description This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and contemplated changes coming on the EU Medical Device Directives.Why should you attend: 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 definitionEssential Device RequirementsMedical Device Type & Process PathMedical Device Technical FileClinical Investigation RequirementsClinical EvaluationsNotified Bodies involvementGain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives... Areas Covered in the Seminar:Definition: Medical Device or Personal Protective Equipment.Overview of the Global Medical Device IndustryStandardActive ImplantedIn Vitro DiagnosticCombination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory PerspectiveAn Overview of the Medical Device Directives.Development, aims, implementation and update of the Medical Device DirectivesImplication of an EU Directive vs. RegulationMedical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination ProductsUpdate on the additional guidance documents relating to the directivesEssential RequirementsClassification of MD's and Process Implications Conformity AssessmentTechnical FileRelationship to EU Clinical Trial DirectiveGuidance Documents.Medical Device Directive Annexes.Compliance Requirements by TypeFull Quality Assurance SystemDeclaration of ConformitySafety.Medical Device Vigilance SystemManufacturer's RequirementsGMPGCPCE MarkingISO CertificationClinical TrialsLabelingISO Standard Certification.Overall process; Management Commitment & InvolvementRole of Notified BodiesRelationship to CE MarkingISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International StandardsISO-14155 Medical Device Clinical Investigations.Part I- Clinical StudiesPart II- Clinical InvestigationsLinkage to EU Clinical Trial Directive; What Does & Doesn't ApplyCompare & Contrast EU & FDA Procedures and Requirements.Process Similarities & DifferencesImplications for IndustryCompany ManagementProcess ChangesManagement Team EffectivenessRegulatory Approval and Liaison with Regulators.EU Co-Decision ProcedureCommittees, Working Parties Relevant for Medical DevicesWhen and How to Influence RegulatorsDo's and Don'ts of Regulatory InvolvementIndividual Company Involvement vs. Trade AssociationAbout 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 Chemistry. Compliance2go | Phone : 877.782.4696 | Fax : 281-971-0286 Email :