Medical Affairs and Scientific Communications Forum

Session Chair(s)

Lakshmi Ramkumar

• Senior Director, Head of Medical Writing
• Moderna, United States

Karen Joyce Hager, MS

• Director, Clinical Trial Management, Global Clinical Operations
• Vertex Pharmaceuticals, United States

The panel will take questions about the EUA submission process and share lessons learned and recommendations for agile submission practices with the audience. There will be emphasis on impact on Medical Writing function.

Learning Objective : At the conclusion of this session, participants should be able to:

• Discuss tips for optimizing the submission timeline and determine when to escalate
• Identify one or more tips for clear effective communication to facilitate the progress the submission timeline
• Define roles and responsibilities of the submission team (i.e. RACI use)