Developing and implementing the right drug safety strategy

Susan Najjar

Developing and implementing the right drug safety strategy is one of the most pressing challenges facing the biopharmaceutical industry today. The focus of the World Drug Safety Conference (WDSC) Americas is on how best to develop an integrated approach to the evaluation of drug safety, focusing on the balance of benefits vs. risk, and the consequent public health impact. However, considering what has transpired within the last several years, we seem to be going in the opposite direction.  We have moved from an era in which different PV systems around the world were fragmented, disconnected, non-uniform and locally specific, through a brief period of relative harmonization towards a unitary approach based on CIOMS and ICH initiatives, to an apparent return to a fragmented, disparate, and disharmonized approach.

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