2024 - The Journey to Approval: Navigating the Road from EoP2 to NDA Submission

The transition from end of phase II (EoP2) to new drug application (NDA) submission is a complex and critical period in bringing new therapies to patients. For sponsors, this stage of development involves juggling challenges across multiple disciplines, from regulatory, nonclinical and chemistry, manufacturing and controls (CMC) to quality, clinical and commercial.
Putting a well-planned NDA playbook in place ensures that all prerequisite pre-filing activities are completed and that the documents and data necessary for submission have been collected in the appropriate formats. Successful execution of this playbook requires a clear understanding of timelines and careful coordination across disciplines, as well as the ability to troubleshoot issues as they arise on a  real-time basis.
In this webinar, the expert speaker will discuss key considerations across the core drug development disciplines for developing a comprehensive NDA strategy and explore opportunities for streamlining the path from EoP2 to NDA submission.
Register for this webinar today to understand how new therapies can be developed by streamlining the path from end of Phase II trials to NDA submission.
Keywords: Drug Development, Drug Approval, Clinical Research, FDA Approval, CRO, New Drug Approval, Investigational New Drug, Regulatory, Regulatory Approval, New Drug Application