Proactive Pharmacovigilance: A New Model for the 21st Century

Summer/Autumn 2013 Volume 5 Issue 3
Sidney N Kahn, MD, PhD, Senior Principal, Sciformix

The impact of 21st century technologies on healthcare delivery will create significant challenges and opportunities for all stakeholders in pharmaceuticals. PV is currently in transition, with new sources of medical information and methods for its analysis being explored to transform the current reactive system into proactive benefit-risk management fully adapted to modern technology and needs.

Regulations are gradually evolving towards a more proactive approach, but remain too procedurally focused, often inhibiting innovation, while the technical resources required for effective benefit-risk assessment are still at an early development stage.

PV is entering uncharted territory requiring industry, regulators, healthcare providers, and patients to confront multiple unknowns that will eventually lead to enhanced benefit-risk assessment, communication and implementation.

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