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SG2 Vigilance and Postmarket Surveillance

Outline of Presentation. Overview of SG2Document statusVigilance Exchange Project. Overview. Focus on manufacturer to Competent Authority reporting systemWhat events to reportWhat information to reportWhen to reportExchange among NCAsVigilance vs. Adverse Events. Document Status. What events

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SG2 Vigilance and Postmarket Surveillance

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    1. SG2 Vigilance and Postmarket Surveillance Larry Kessler, Sc.D. and Kim Dix

    2. Outline of Presentation Overview of SG2 Document status Vigilance Exchange Project

    3. Overview Focus on manufacturer to Competent Authority reporting system What events to report What information to report When to report Exchange among NCAs Vigilance vs. Adverse Events

    4. Document Status What events to report: N21 Implementation !!! Trending exemptions from reporting: N36 Proposed for comment: Link to QSR/SG#3 What data to report: Universal Data Set: N32 Complete: Administrative review Descriptive documents: Comparison of surveillance systems: N6; Common and Well Characterized Events: N30

    5. Remaining Challenges for SG2 When to report to NCA: N33 Reporting of events involving use error or user error: N31 Vigilance Exchange System Vigilance Reporting Criteria: N20 Complete: Administrative review

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