EMWA Budapest Working Group: ICH E3 and E6 Forensics – a two-year roadmap for alignment with current practices
EMWA has initiated collaboration with many stakeholders, including professional associations, regulators, and key industry participants, to review the ICH E3 and ICH E6 guidelines in a 2-year project that began in May 2014. The EMWA-incepted Budapest Working Group© (BWG) comprises experts in ICH E3, ICH E6, protocol and clinical study report templates, and disclosure and transparency. Our strategist is working with partner and stakeholder organisations. With stakeholder involvement from the outset, the aim of this project is to encourage participation amongst all affected parties, to best ensure that the anticipated recommendations address the needs of the broadest possible community, following developments over the 20 intervening years since these guidelines were first issued. Sam Hamilton (EMWA Vice President and BWG Chair) and Art Gertel (EMWA Fellow and BWG member) will present their first publication of the project at the EMWA Conference in Florence on Friday 07 November 2014, 12.45 – 13.20. For more information on the conference visit:
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Budapest Working Group© 2014 Sam Hamilton, All Rights Reserved.