Submitting a New Drug Application (NDA) or Biologics License Application (BLA) is one of the most critical and complex milestones in drug development, marking the culmination of years of cross-disciplinary effort.
For many trial sponsors, particularly those embarking on this journey for the first time, knowing where to start and how to measure progress can be daunting. Success requires strategic planning, strong cross-functional alignment, and a clear understanding of regulatory expectations.
In this webinar, our regulatory submission and data experts will equip attendees with best practices for a staged approach to achieving submission goals, from early planning though the final information request- helping you to eliminate unknowns and build confidence at every phase.
- Gain insights from industry experts who have guided trial sponsors of all sizes through multiple successful regulatory submissions.
- Understand the timing, execution considerations, dependencies, and tools involved in planning and submitting a successful NDA or BLA.
- Learn how to structure your submission approach, from early planning through the final information request.
- Timing: A staged approach to NDA/BLA planning will be discussed, allowing sponsors to break the process down to a manageable sequence of steps.
- Execution: Critical steps to operationalize NDA planning will be reviewed across multiple disciplines including statistics, regulatory strategy, medical writing and regulatory operations.
- Dependencies: Key dependencies at each planning stage will be identified, allowing sponsors to accurately assess the progress of their programs.
- Tools: Key project management and alignment tools will be covered with an emphasis on early adaptation.
Our expert panel of regulatory and biostatistics strategists will provide practical insights and actionable takeaways to support your submission journey.
Don’t miss this opportunity to gain essential NDA/BLA submission insights and ask our team your most pressing questions during the live Q&A.
- Regulatory Affairs and Submissions Professionals
- Medical and Regulatory Writing Professionals
- Clinical Operations and Clinical Development Professionals
- Clinical Data Professionals and Biostatisticians
The webinar is suitable for professionals from pharmaceutical and biotechnology companies of all sizes, involved in, or interested in strategies for successful regulatory submissions.
Register Now
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