European Medicines Agency workshop on extrapolation across age groups

Date: 30/09/2015
Location: European Medicines Agency, London, UK
The primary rationale for extrapolation is to avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are most needed. In situations where the feasibility of studies is restricted, extrapolation principles may be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources. As per the published European Medicines Agency (EMA) concept paper on extrapolation of efficacy and safety in medicine development, EMA is developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. With the aim of developing the regulatory framework the Agency is holding an EMA experts workshop on 30 September. This workshop aims to bring together experts from the European medicines regulatory network. Registration by invitation only.

Documents

How useful was this page?

Add your rating