Benefit-risk methodology project: Work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessment

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Publication Date 2010
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This paper reviews approaches for balancing benefits and risks in decision making about medicinal products. Its publication represents the finalisation of the second step of the Agency’s five-step project, which aims to make its decision-making on the benefits and risks of medicines more transparent, more consistent and easier to audit.
Source Link http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/10/WC500097750.pdf
Related Links
EMA: News, 13.10.10: European Medicines Agency publishes second work package of benefit-risk methodology project http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/10/news_detail_001129.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
EMA: Special topics: Benefit-risk methodology http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp&mid=WC0b01ac0580223ed6&murl=menus/special_topics/special_topics.jsp
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