The CORE Reference Project - Value for the Global Regulatory MW Community

5:15 PM - 6:15 PM

Abstract: The CORE Reference EMWA Special Project provides Continuous Professional Development (CPD) for regulatory medical writers through open access resources and intelligence dissemination on clinical study reporting and public disclosure of clinical-regulatory documents. The team will present a 60-minute open session including a full web tour; demonstration of the CPD resources, including the RPD content published monthly; a PDF open-book demonstration of CORE Reference and its practical utility; insights on the ICH M11 Step 2 draft protocol template; and we will take questions from the audience.

Presenters names (with affiliations): Chair, Sam Hamilton (Freelance); Committee - Alison McIntosh (Freelance), Vivien Fagan (IQVIA).