Safety Reporting

Safety reporting in pharma and biotech is a highly regulated requirement that is necessary throughout the lifecycle of any therapy under development or already approved. 

There are specific definitions of safety events; defined by the International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use), referred to as ICH.  Safety reporting definitions and requirements are also outlined in the United States Code of Federal Regulations (CFR). 

Here are some examples of safety definitions:

Serious Adverse Event (SAE):  

If an untoward event results in death, is life-threatening, leads to hospitalization, disability, congenital anomaly or other important medical event it is considered an SAE.

Serious Unexpected Suspected Adverse Reaction (SUSAR): an untoward and unanticipated response to a study drug

In addition to the definitions for safety reporting, there are specific rules that must be followed regarding reporting these events to appropriate regulatory authorities such as FDA.

The guidance regarding safety reporting for INDs (Investigational New Drugs) is a great example. 

Not only do pharmacovigilance teams have to know these regulations, clinical development and medical affairs are examples of other roles/teams that must as well!  

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