EMWA-AMWA have partnered to develop the all-new CORE (Clarity and Openness in Reporting: E3-based) Reference, scheduled to be available by mid-2016. CORE will take the form of a User Manual intended to assist CSR authors, and complementing the existing 1995 ICH E3 guidance and 2012 ICH E3 Q&A update. The CORE Reference is being developed in close collaboration relevant Stakeholders. The CORE Reference project began as a detailed review and recommendation project on ICH E3, led by the EMWA Budapest Working Group (BWG). It is strengthened by its evolution into this international EMWA‑AMWA partnership with global reach. Read the Press Release for further details: http://www.emwa.org/CORE CORE Press Release-28jan15_final
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I am a freelance medical writer providing a range of writing services, primarily to the pharmaceutical industry. I am a post-doctoral virologist working in clinical research since 1994, and specialising in regulatory medical writing from 1999. In my last salaried position (to September 2006), I managed UK Medical Writing for the world’s fifth largest Contract Research Organisation.

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