DIA 2017 Annual Meeting

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Driving International Awareness and Use of Regulatory Writing Guidelines: Case Studies of the Clarity and Openness in Reporting (CORE) Reference Guidelines

Session Chair(s)

Art Gertel, MSc

President and Principal Consultant

MedSciCom, LLC, United States

The Clarity and Openness in Reporting: E3-based (CORE) guidelines were developed to help companies prepare disclosure-ready clinical study reports mandated by the EMA in a timely and cost-effective manner, and without risking inadvertent disclosure of sensitive information. Using the CORE guidelines as an example, this session will examine how to develop guidelines that can be used to enhance transparency in the real world, across the world.

Learning Objective : Identify how to prepare disclosure-ready clinical study reports.

Speaker(s)

Best Practices for Driving Awareness and Use of International Guidelines: CORE Reference Guideline Case Study - EU, US, Japan

Hiroko Ebina, MBA, RPh

Proscribe KK - Part of the ENVISION PHARMA GROUP, Japan

Principal Writer I

Case Study for (CORE) Reference Guidelines

Vivien Fagan

IQVIA, United Kingdom

Director, Global Medical Writing

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