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EU Policy 0070

Best Industry Practices for Clinical Trial Disclosure

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Tag: EU Policy 0070

Qualitative vs Quantitative Risk Assessment Summary

Developing a Risk Assessment for a Policy 0070 submission must follow many regulations and standards. There are two main types of risk assessments, a qualitative risk assessment and a quantitative risk assessment. Qualitative Risk Assessment A qualitative risk assessment seeks to use ‘relative’ levels of risk based on factors such as prevalence of the indicated […]

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