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The Role of Regulatory in Safety

This is one of those that generally varies from company to company, but one thing that is important to remember is that Regulatory *does* have a role in Safety.

Risk Evaluation and Mitigations Strategies can have a large Regulatory component as an example. If you have a Medication Guide, that falls under labeling. Many of the Elements to Assure Safe Use (ETASU) have regulatory components. Sending in Expedited Safety Reports to the FDA usually falls under Regulatory's bailiwick.

It is essential that Regulatory has a basic understanding of Pharmacovigilance, and it is especially important in today as often, Regulatory is required to step outside the box of just looking at regulations, and actually helping make strategic decision that impact the safety set-up of the products.

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