Titlebook: Benefit-Risk Assessment of Medicines; The Development and James Leong,Sam Salek,Stuart Walker Book 2015 Springer International Publishing

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Approaches to Utilizing Decision-Making Framework,niversal framework that is able to meet the needs of the various stakeholders. Based on the background information reviewed thus far, it appears that a universal benefit–risk assessment framework should:

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,Benefit–Risk Assessment of Medicines by Pharmaceutical Companies and Regulatory Authorities,y for such important decisions, there have been attempts to utilize quantitative approaches in assessing benefits and risks of a medicine (EMA 2009). As a result, pharmaceutical companies have also initiated the use of quantitative approaches in developing their products for submission to the regulatory authorities (Levitan et al. 2011).

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,Implementation of the Benefit–Risk Assessment Template by Mature Agencies, thus developed (Chap. .) with inputs from the Consortium (consisting of TGA, Health Canada, Swissmedic, and HSA), and the resulting universal Benefit–Risk (BR) Template was designed to enhance communication and documentation of benefit–risk decisions. This study aims to review the potential value of the BR Template for regulatory agencies.

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978-3-319-36767-5Springer International Publishing Switzerland 2015

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Lecture Notes in Physics Monographsefficacy. As patients are not equipped to make a scientific assessment, regulators play an important role in controlling the access to safe and effective medicines. Two of the key elements highlighted by the World Health Organization (WHO 2003) for effective regulation of medicines included strong c

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