返回 Agenda
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)
Deborah Collyar
President, Patient Advocates In Research (PAIR), United States
Clues into Diverse Patient and Public Needs for Clinical Trial Summaries
Jill McNair, MBA
Key Account Director, Scott Clinical, United States
Leveraging Lay Summaries as a Meaningful Approach to Patient Engagement and Not Just a Regulatory Requirement
Mitzi Allred, PHD
Director, Clinical Operations, United States
Using TransCelerate’s Common Protocol Template to Enable Disclosure to Trial Registries
Denise Qyqja
Sr. Manager CTD & Patient Engagement , Transperfect, United States
Anonymizing Individual Patient Data - Data Utility Focus
Thomas Wicks, MBA
Head of Transparency Operations, Citeline, United States
The Global Transparency Challenge
Margaret Zorn, MBA, MS
Senior Information Scientist, Instem, United States
Getting Ahead of the EU CTR Lay Summary Requirement: Strategies for Success