The requirement to properly plan, track and manage signals from all sources has never been greater than in the past decade.

Over half the signals managed by the European Medicine Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) in its first year of operation (2012), resulted in changes to the product information1 and we are seeing an increasing focus by inspectors on signaling strategies. With the evolving Pharmacovigilance (PV) regulations, new inspection topics related to signal detection are arising.

In this poster, Quintiles experts share their experience on the thinking process to build a robust and compliant signal management system adapted to the type of company and products.

Authors: Margot Stam Moraga, Director – Signal Management Services, Benefit-Risk Management, Quintiles, Switzerland

Deirdre McCarthy, Senior Benefit-Risk Management Director, Quintiles, 201 Broadway, Cambridge, Massachusetts 02139, USA

Right sized signal detection systems that meet regulatory expectations