​Why pharma must integrate R&D, manufacturing, and marketing efforts to minimise patient risk.

Eighteen months ago, Nostrapharmus predicted 'the implementation of processes that enable R&D teams to proactively identify and mitigate risk, coupled with Drug Safety's ability to build 'peer to peer' relationships with clinical colleagues enabling them to take strategic, longer-term views of product risk' was needed to enhance patient safety.  Now, more than ever, Nostrapharmus believes that safety's role within pharmaceutical organisations must be one of leading proactive, cross-functional co-ordination of holistic strategies aimed at minimising and monitoring risk from product inception through to market withdrawal and from point of manufacturing through to utilisation.

In the wake of recent court rulings that emphasise the responsibility for product manufacturing, supply, and administration to lie squarely at the foot of the pharmaceutical industry; patient safety and the role the MAH plays in co-ordinating activities to minimise patient risk has again been pushed to the centre of both public and government debate.  Add to this the turbulent regulatory environment that continues to move towards risk-based assessments and publication by agencies of product 'watch lists' and there is increasing pressure on the role that safety functions play in pharmaceutical organisations.

To read the article in full, please click on the pdf link below:

Integration to minimise patient risk.pdf

or to read the magazine, please click on the link below, the article can be found on page 50:

http://viewer.zmags.com/publication/f4349e2a#/f4349e2a/50

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