Introduction Innovation Task Force Benefit-risk assessment Biomarkers Emerging technologies Pharmacogenomics Nanotechnology Process Analytical Technology New manufacturing technologies Innovative Medicines Initiative How to get support from the European Medicines Agency? Related information sources See also: Advanced Therapies

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Medicines and Emerging Science

Benefit-risk assessment

EMEA/CHMP/15404/2007 - Reflection Paper on Benefit-Risk assessment methods in the context of evaluation of Marketing Authorisation application of medicinal products for human use

EMEA/CHMP/15404/2007 - Report of the CHMP Working Group on Benefit-Risk Assessment Models and Methods