Article from TOPRA, Regulatory Rapporteur – Vol 9, No 10, October 2012.
Remodelling pharmaceutical R&D and the role of regulatory affairs
AuthorSharon Maglennon, Director, Zeifion Consulting Ltd, Devon, UK.
This article summarises the results of exploratory regulatory research undertaken for a TOPRA MSc dissertation. The research investigated declining productivity in pharmaceutical R&D, the reasons behind this, the various initiatives and potential solutions to reverse this trend, and the implications for the regulatory function.
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