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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.

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iNtegratioN to MiNiMize patieNt risk
why Pharma must integrate R&D, manufacturing and marketing efforts to minimize patient risk
                ighteen months ago Nostrapharmus       knowledge transfer. Not only is it a regulatory         The Time to Act is now
                predicted ‘the implementation of       requirement in several existing markets, but            So, how can organizations ensure that their
                processes that enable R&D teams        the ability to thoroughly identify, monitor, and        development, medical affairs, regulatory, marketing,
                to proactively identify and mitigate   mitigate potential, or known, risks is essential        manufacturing, supply, and safety personnel work
risk, coupled with Drug Safety’s ability to            for an enhanced understanding of a product’s            efficiently and effectively together to strive for
build ‘peer to peer’ relationships with clinical       characteristics. To further understand how              greater understanding of their product’s benefits
colleagues enabling them to take strategic,            a product will behave in different patient              and risks at each stage of the PLC? Who is best
longer-term views of product risk’ was needed          populations and administrative settings (eg.            placed to ensure that planned activities deliver their
to enhance patient safety. Now, more than ever,        community surgeries, hospitals, specialised             proposed benefits and, if seen to fail, will rapidly
Nostrapharmus believes that safety’s role within       research institutions), co-ordinated global             and effectively address strategic shortcomings?
pharmaceutical organisations must be one of            processes must be installed that routinely                  Nostrapharmus believes that safety must
leading proactive, cross-functional co-ordination      bring together experience gained from diverse           maintain oversight and co-ordinate continuous
of holistic strategies aimed at minimizing             functions. However, effective processes for             improvement programmes aimed at collating
and monitoring risk from product inception             the co-ordination of Safety Risk Management             experience of strategies designed for enhancing
through to market withdrawal and from point of         (SRM) activities across historically independent,       understanding of a product’s use and minimizing
manufacturing through to utilization.                  global corporate silos are still relatively rare and    patient risk. Safety cannot, and should not, go
    In the wake of recent court rulings that           undefined. Also, there is an increasing body            it alone but must be authorised, resourced and
emphasize the responsibility for product               of evidence that agencies are demanding                 effectively skilled to ensure:
manufacturing, supply, and administration to           evidence of such processes, demonstrating               • Multi-functional Safety Management Teams
lie squarely at the foot of the pharmaceutical         sound communication, heightened transparency               operate the SRM process with accountability
industry; patient safety and the role the MAH          and timely co-ordination between Safety and                for aligning whole business to SRM
plays in co-ordinating activities to minimize          Manufacturing functions.                                   approaches and practices
patient risk has again been pushed to the centre          There is some evidence that the industry is          • Unambiguous lines of responsibility are
of both public and government debate. Add              moving towards effectively tackling these issues,          defined so that commitments necessary for
to this the turbulent regulatory environment           with the focus mainly concentrated on R&D                  determining and ensuring a product’s safety
that continues to move towards risk-based              functions, but still more complex and greater              are u
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