Compliance & Vigilance Analysis/Evaluation
Compliance & Vigilance Analysis/Evaluation
Identify countries products are sold
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Update reporting timing per Article 82 (2)
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Incorporate foreign country notification into Notification Assessment
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Train distributors on complaint notification
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Develop trend reporting per Article 83
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Integrate complaint handling and risk management procedures
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Align complaint handling/recall/HHE vigilance procedures
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Create quality trend reports for nonserious events
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Consolidate monthly sales by SKU/product family
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Utilize Internal Sales Data
Establish alert/action limits for non-serious harms
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