There is a tide of change in the pharmaceutical industry with a push for drug safety to have a stronger role within clinical development.  Taking drug safety operations from the reactive approach that dominates the industry to a more proactive stance is the right direction as drugs are now omnipresent in all facets of our lives.  However, this does call for a huge cultural and technology shift in the world of drug development.

Distant Shores

Pharmaceutical companies have been under scrutiny due to highly public drugs failures such as Vioxx last year - the largest prescription drug withdrawal in history

Stakeholders are all concerned with how to identify Adverse Drug Reactions (ADRs) earlier in the product lifecycle, so that better decisions can be taken on their mitigation before the product reaches the marketplace. 

To achieve this, drug development must be less reactive and more proactive.  Which means that drug safety and clinical should be working in tandem, rather than as two distant spectrums of product development and marketplace monitoring.

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Tide of change in drug safety.pdf