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Session 8: Oral Abstract Presentations
Session Chair(s)
Erik Lakes, MS, MSc
Senior Director and Head, Data Disclosure & Transparency
Beigene, United States
Clinical trial sponsors and academia are facing a multitude of new registration requirements in the US and the EU. With evolving requirements come new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. Seize this opportunity to engage with and gain insights from your fellow attendees by attending this abstract session showcasing research, best practices, and practical applications related to the implementation of the new clinical trial regulations in the US and EU, anonymizing data, and data-sharing.
Speaker(s)
Clues into Diverse Patient and Public Needs for Clinical Trial Summaries
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President
Leveraging Lay Summaries as a Meaningful Approach to Patient Engagement and Not Just a Regulatory Requirement
Jill McNair, MBA
Scott Clinical, United States
Key Account Director
Using TransCelerate’s Common Protocol Template to Enable Disclosure to Trial Registries
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
Anonymizing Individual Patient Data - Data Utility Focus
Denise Qyqja
Transperfect, United States
Sr. Manager CTD & Patient Engagement
The Global Transparency Challenge
Thomas Wicks, MBA
Citeline, United States
Head of Transparency Operations
Getting Ahead of the EU CTR Lay Summary Requirement: Strategies for Success
Margaret Zorn, MBA, MS
Instem, United States
Senior Information Scientist
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