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Thursday, June 22 • 10:45am - 11:45am
#403: Driving International Awareness and Use of Regulatory Writing Guidelines: Case Studies of the Clarity and Openness in Reporting (CORE) Reference Guidelines

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Identify how to prepare disclosure-ready clinical study reports.

Chair

Art Gertel

Speaker

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

Case Study for (CORE) Reference Guidelines
Vivien Fagan


Moderators
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →

Speakers
avatar for Hiroko Ebina

Hiroko Ebina

Principal Writer I, Proscribe KK
Principal Writer I, ProScribe KK – Envision Pharma Group, Japan; 12 years’ regulatory writing experience in pharmaceutical companies; DIA member, Asia Pacific representative (DIA Medical Writer Competency Model Taskforce) ; ICH E3 Q&A Deputy Topic Leader (Japanese Pharmaceutical... Read More →
avatar for Vivien Fagan

Vivien Fagan

Director, Global Medical Writing and Document Publishing, QuintilesIMS
Vivien has over 20 years of experience in an international CRO and has written numerous regulatory documents (including protocols and CSRs) for all phases of studies for a variety of pharmaceutical sponsors and biotechnology companies. In her current position, Vivien manages QuintilesIMS... Read More →
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →

Thursday June 22, 2017 10:45am - 11:45am
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  03: MedAffairs-SciComm, Session