Risk management strategy progressing nicely

By Katrina Megget

- Last updated on GMT

Related tags Risk management European union

European pharmaceutical and medical authorities have announced
their satisfaction on the progress being made with the European
Risk Management Strategy (ERMS) following a meeting earlier this

Set up in 2002, the European Medicines Agency (EMEA) and Heads of Medicines Agencies (HMA) outlined a strategy which would act as a practical approach to managing the risk of medicines throughout their lifecycles. Following a meeting in Lisbon, Portugal, on July 10, the agencies discussed the achievements made between 2005 and 2007 and identified the priority areas for the next two years. Some of the achievements listed included: implementing the legal tools for monitoring the safety of medicines and for regulatory actions provided for by revised EU pharmaceutical legislation; strengthening the spontaneous reporting scheme by further improvements to implementation of an electronic reporting database, EudraVigilance, on adverse drug reactions; launching the European Network of centres for Pharmacoepidemiology and Pharmacovigilance project to strengthening monitoring systems by facilitating the conduct of multi-centre post-authorisation safety studies; conducting research in the field of pharmacovigilance and safety of medicines in the context of the Health Theme of the 7th​ Framework Programme; and strengthening the organisation and the operation of the EU Pharmacovigilance System. "Medicines do have risks, that's the nature of the beast,"​ EMEA spokeswoman Monika Benstetter told in-PharmaTechnologist.com. "This strategy is to deal with the risk and to manage and make it more manageable." ​ Right from the early stage of drug development through to the packaging and distribution, risks can occur, she said. The idea was to devise better risk detection, risk assessment, risk minimisation and risk communication throughout the lifecycle. The priority now for the next two years was to further improve the operation of the EU Pharmacovigilance System, which would involve ensuring reporting requirements were adhered to, rigorously compiling data and looking at how authorities could work together. The other priority would be strengthening the science that underpins the safety monitoring of medicines. These two areas would be affected by the European Commission's Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance, which is being developed as a legal proposal to be presented in 2008 to detect and deal with safety issues. A work programme on the activities to be undertaken over the next two years will be published in November at the HMA meeting.

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