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Session 9B1: Hot Topics in Clinical Trial Transparency
Session Chair(s)
Michael Church, MA
Senior Director, Medical Writing
Syneos Health, United States
Examine ongoing clinical trial transparency initiatives and their impact within the pharmaceutical industry, particularly scientific communications. We will discuss the scope EMA Policy 0070 and look at its effect on the way clinical study reports and clinical data summaries are being written. We will also cover the basics of the regulations surrounding the clinical trial transparency in the EU and provide best practices for avoiding pitfalls in the creation of lay language summaries due to vague requirements within those regulations; in addition, we will focus on the purpose of lay summaries and the benefits of using particular tools in their preparation.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the scope and impact of EMA Policy 0070 on the pharmaceutical industry
- Implement best practices for avoiding pitfalls in the creation of lay language summaries
- Assess the benefits of the use of particular tools in the preparation of lay language summaries
Speaker(s)
EMA Policy 0070: A Game Changer for Industry
Robert Paarlberg, MS
Paarlberg & Associates LLC, United States
Principal
Interpreting the Lay Summary Regulations into Lay Language
David Meats
Certara, United States
Director, Regulatory Services Management
TransCelerate Date, Transparency Updates, and New Developments
Helle Gawrylewski, MA
Hawkwood Consulting, LLC, United States
Owner
Panel Discussion
All Session Speakers, United States