Risky Signal Management - where your system is probably falling short - Quintiles

Pharmacovigilance is all about identifying, assessing, understanding and preventing adverse drug reactions. To do that effectively, biopharma companies need to screen the signals that could lead to an adverse reaction. Signal management relates to the safety information we gather from variety of sources, including spontaneous reports, clinical studies and scientific literature, which are potentially caused by a medicine and warrant further investigation, to confirm new adverse reactions or changes to known risks causally associated to this medicine. 

Proactively detecting signals for the identification of risks related to a drug is essential for the patients’ safety and can have significant impact on the drug’s marketing status. Approximately 40 percent of the confirmed signals managed by the European Medicine Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) in 2014 resulted in changes to the product information, including distribution of Direct Healthcare Professional Communications (DHPCs). And in 2013, 50 percent of all signals reviewed resulted in changes in labeling. In the EU, transparency, compliance and quality are critical elements of the pharmacovigilance (PV) legislation. In the U.S., the Food and Drug Administration continues to expect strong and swift signal detection and analysis throughout a product’s lifecycle.

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Risky Signal Management - where your system is probably falling short - Quintiles