返回 Agenda
Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities
Session Chair(s)
Susannah Chang, PHD
Manager, Oncology Regulatory Medical Writing
Janssen Pharmaceutical Companies of Johnson & Johnson, United States
For the first time there is regulation in a key geographical area that mandates that trial results are presented in a lay friendly way. This session will discuss how this is a unique opportunity to redefine the relationship between sponsors, investigators, study participants, and patient organizations. Although limited to the EU, most sponsors will make lay summaries available globally.
Learning Objective : Describe the challenges of actual writing of lay summaries and the implementation of a process for individual sponsors.
Speaker(s)
Plain Language Summaries: Large Scale Writing and Process Implementation
Tatyana Wanderer, PHD
Moderna, United States
Executive Director, Head of Medical Writing and CTD
Layperson Summaries: Gathering Patient Insights and Evolving Processes
Amber Barnes, PHD, RAC
UCB Biosciences, Inc., United States
Director, Global Medical Writing
Meeting the EU Mandate for Plain Language Trial Results Summaries: Successes, Challenges and Key Considerations
Behtash Bahador, MS
Center for Information and Study on Clinical Research Participation (CISCRP), United States
Senior Director, Community Engagement & Partnerships
Meaningful Information Exchange with Trial Participants: Update From the TransCelerate Information Exchange Team
Julie Dietrich, MS
United States
Senior Director, Clinical Development