Infarmed Regulatory Training handouts - 14 Nov


Work Shop/Interactive Exercise 2: Risk Based Incident Report Evaluation

Post-Production Risk Management – Post-Market Surveillance • The Incidents/Events shall be analyzed by: • type, • trends, • status of any corrective or preventive action and • the effectiveness of the action(s) taken.

Evaluation of a real world incident report case studies from a risk management perspective: - Known versus unknown harms - Probability of Occurrence vs. Risk Acceptance - Potential versus actual harm - Health Hazard Evaluation. - Need for Post-Market Corrective Action? - Additional information requests to manufacturers?

• Management shall evaluate the information presented and determine if any additional risk mitigation or other action(s) is required. • Risk Management File is subject to periodic updates and reviews.

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InfarmedRiskManagementTraining2017NOV14 |Confidential | 80

Summary and QA Session

Thank You


16:15 16:45

Summary and Q&A Session

Close of day

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InfarmedRiskManagementTraining2017NOV14 |Confidential | 82


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