Module 16 2024

22/10/2024

Conclusions

Product liability is an unavoidable cost of doing business

Part of the risk assessment equation

Can you get it wrong?

● “The following adverse events occurred sporadically in single patients and cannot be distinguished from concurrent disease states and medications: ___, ___, ___, ___”

● “Voluntary reports of adverse events in patients taking X since market introduction and not listed above that may have no causal relationship with the drug include ___, ___, ___, ___, etc.”

The Organisation for Professionals in Regulatory Affairs

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23

Regulatory Action Against Products

Safeguard measures

Precautionary principle

The Organisation for Professionals in Regulatory Affairs

24

24

12