|A Paradigm Shift in Pharmacovigilance for Established ProductsWith patent expirations on the rise and organizations focusing on market expansion opportunities, substantial penetration of generic medicinal products in both developed as well as emerging markets is now a clear trend in the industry.
The origin of pharmacovigilance or product vigilance (PV) itself was a reaction to public health disasters caused by medications such as the well-known thalidomide disaster in 1962. PV was all about collecting anecdotal reports of suspected adverse drug reactions (ADRs) and using these to detect significant, previously unrecognized hazards of medications after their introduction into clinical use. But there’s now a movement towards a proactive approach based on prevention rather than a reactive approach driven by public health outcomes. Regulators are moving from reactive safety oversight driven by procedural compliance to a practical, health-based approach which is clinically more relevant and meaningful (Kahn, 2013).
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