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Robin Williams, B.S., CMC, Senior Safety Scientist, Ashfield Pharmacovigilance

What defines a signal? Why do we need to do signal detection and what steps are involved? Although signal detection can take many forms, there are basics to the process no matter where you market your products.

The FDA defines a safety signal as a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use.

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