One of the biggest responsibilities of a biopharmaceutical
or medical device company is to ensure their products
are safe as well as effective. A significant part of the
clinical trial process before approval involves examining
the safety profile of a new medicine to understand any
potential risks to patients. The need to ensure the safety
of an innovative treatment doesn’t stop the day regulators
approve it for sale, however. Manufacturers must monitor
how each product they sell performs with real patients
as they use it outside the carefully controlled conditions
of a clinical study. This process of multivigilance—the
management of safety information for different kinds of
medicinal products such as drugs, biologics, vaccines,
medical devices, and combination products—is required
throughout the entire product lifecycle.