important identified risk
- Guideline or reference source
- ICHE2C(R2) Guideline
- ICHE2F Development safety update report
- Definition
- An identified risk or potential risk that could impact on the risk-benefit profile of the product or have implications for public health. What constitutes an important risk will depend upon several factors, including the impact on the individual, the seriousness of the risk, and the impact on public health. Normally, any risk that is likely to be included in the contraindications or warnings and precautions section of the product labelling should be considered important.
- Broader Term
- identified risk
- safety concern
- Related Term
- important potential risk
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