Reactions 1597, p6 - 16 Apr 2016

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PROTECT improves benefit-risk monitoring of medicines in EU Key results from the EU-funded PROTECT* project are now available in a series of different medical journals, according to the EMA. The PROTECT project was funded by the Innovative Medicines Initiative joint undertaking, comprising a 34-strong consortium of academics, regulators and pharmaceutical companies that was coordinated by the EMA and GlaxoSmithKline from September 2009 until June 2015. This project aimed to develop innovative methods to strengthen the benefit-risk monitoring of medicines in the EU. The Head of the EMA’s Pharmacovigilance (PV) Department, Mr Peter Arlett, stated that "PROTECT has made a significant contribution to the body of scientific knowledge of benefit-risk monitoring methodologies". Mr Arlett added that results from this project are being implemented into routine PV activities and regulatory practice, and that improvements in the monitoring of medicines in the EU have already been seen. The main results and recommendations from PROTECT that have been published include: • a guidance for observational studies on medicines in several databases and several countries with common protocols; • significant improvements to signal detection methods employed by national and international regulatory agencies and pharmaceutical companies following an in-depth review of good detection practices; • recommendations for benefit-risk assessment methodologies and visual representations based on real-world case examples to aid clear and transparent decision-making; and • exploration of new methods to collect data directly from patients, including via the internet. Reports, publications, presentations and databases generated by PROTECT are available on the PROTECT website (www.imi-protect.eu) and a specific PROTECT benefit-risk website (http://protectbenefitrisk.eu). * PROTECT = Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium European Medicines Agency. Better safety for patients through EU-funded research. Internet Document : 4 Apr 2016. Available from: URL: http:// www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/ 803179578 news_detail_002494.jsp&mid=WC0b01ac058004d5c1

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Reactions 16 Apr 2016 No. 1597