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Global Medical Device Adverse

Global Medical Device Adverse Event Reporting Systems in EU, Canada and US - Webinar By GlobalCompliancePanel

Overview: Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements. This webinar will walk you through to help you understand the applicable adverse event reporting requirements and remain in conformity with the requirements in EU, Canada and US.This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner. Why Should You Attend: Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable.To achieve compliance and to remain compliant with the adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.This webinar will walk you through to help you understand and stay in conformity with the adverse event reporting requirements in EU, Canada and US.Areas Covered in the Session:Applicable and relevant regulations in EU, Canada and USDefinitionsMedical device adverse event reporting requirements in EU, Canada and USMedical device vigilance system during the post-production phase in EUMandatory medical device problem reporting requirements in CanadaMandatory medical device reporting requirements in USReview of actual reporting forms in EU, Canada and USApplicable and relevant guidance documentsConclusionWho Will Benefit:Regulatory Affairs Managers, Directors and VPsClinical Affairs Managers, Directors and VPsQuality Managers, Directors and VPsQuality Managers, Directors and VPsCompliance Managers and DirectorsSales and Marketing Managers, Directors, and VPsComplaint Handling and Risk Management Managers and DirectorsSite Managers, Directors, and ConsultantsSenior and Executive ManagementCompliance Officers and Legal CounselBusiness Development Managers, Directors, and VPsUSAGlobalCompliancePanel,Livermore Common, Fremont, CA, 94539USA Phone:800-447-9407Fax: 302-288-6884

When

20 Mar 2013 @ 10:00 am

20 Mar 2013 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Where

Online Webinar


Organised by

GlobalCompliancePanel (deactivated)

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