FDA Center for Biologics Evaluation and Research (CBER) requests during vaccine submissions can have implications that extend far beyond isolated SDTM mapping updates. Changes may cascade across ADaM datasets, tables, figures and listings (TFLs), supporting documentation, and ultimately overall submission readiness.

How can teams evaluate and implement CBER-requested changes while maintaining scientific integrity, traceability, and reproducibility? 

In this webinar, Cytel experts will share practical experiences and lessons learned from a recent vaccine submission preparation, drawing on three years of retrospective CBER feedback.

Key Topics: 

• Evaluating and implementing CBER-requested changes across the submission package while preserving scientific integrity, traceability, and reproducibility of study results
• Conducting impact assessments and managing submission remediation in response to CBER feedback
• Enabling effective cross-functional collaboration between programmers, statisticians, clinicians, and regulatory stakeholders
• Maintaining readiness to address FDA questions throughout the application review process

Speakers: 

• Angelo Tinazzi, Senior Director, Statistical Programming 
• Virginie Jego, Director Biostatistics 
• Mark Malayas, Principal Statistical Programmer