Achieving positive topline results in a clinical trial is a major milestone, but it’s only the beginning of the complex regulatory submission process. From this point forward, pharmaceutical companies must navigate a demanding timeline that requires strategic planning, rigorous collaboration, and adaptability to address regulatory expectations.

This webinar will provide pharma decision-makers with a visual roadmap of the post-topline journey, exploring key milestones, unexpected challenges, and best practices for ensuring a smooth path to approval. Join us to gain critical insights into the statistical and programming tasks that are essential yet difficult to predict. 

Key Topics

• Three Submission Scenarios: A comparative analysis of different timeline models from topline results to regulatory approval. 

• Regulatory Interactions: Understanding ad hoc and unexpected requests from regulatory agencies and their impact on submission timelines. 

• Post-Unblinding Data Challenges: Strategies to manage statistical and programming complexities in the final submission phase. 

• Visualizing the Road to Approval: A timeline-based approach to tracking milestone dates and key decision points. 

Speakers

• Jasperlynn Kao, Associate Biostatistics Director
• Florence Le Maulf, Biostatistics Director