VIEWS: 10 PAGES: 2 CATEGORY: Medicine POSTED ON: 6/18/2010
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.
nostrapharmus www.pharma-mag.com 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
Pages to are hidden for
"INTEGRATION TO MINIMIZE PATIENT RISK"Please download to view full document