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Product management

In pharmacovigilance, a product refers to a medicinal product or drug that is being monitored for its safety and efficacy. The product can be a prescription drug, biologic, vaccine, herbal medicine, or any other health-related product that is used to diagnose, treat, prevent, or alleviate medical conditions in humans.

In the PV application, under the PRODUCT tab, you can configure a custom library of products also known as the Company Drug Dictionary (CDD) that defines products that can meet regulatory requirements and internal reporting obligations for global organizations.

Important

Usually, only company products are configured under the PRODUCT module. Non-company products need to be configured only if there is a need to assess the product-associated event expectedness.

In PV, the products are grouped into product families by their active ingredient, and each product has its licenses configured.

Product explorer tree structure
Figure 1. Product explorer tree structure

Important

The product configuration process in the PV application can be customized to suit the sponsor's requirements according to the company's internal workflow of a product release.

The suggested product configuration flow you can see in the following schema.

Product configuration flow
Figure 2. Product configuration flow

In this section, you can learn how to do the following: