Regulatory Submissions, Information, and Document Management Forum

Speed to patient is a fundamental concept in the regulatory and submissions world. When crunch time hits, it appears inevitable that the submissions team is asked how to make the submission process move faster and that request typically follows with little budgetary support. Planning for electronic common technical document (eCTD) submissions can seem like a complex and confusing process. Key drivers for speed to submissions are the right building blocks: clear processes and high quality. There are a few critical steps companies need to take to make this process run smoothly. Taking time to ensure submissions are completed properly and formatted correctly, the first time is imperative. If any of these steps are overlooked, submissions can take longer, cost more, and impact future lifecycle submissions. This session will evaluate and discuss the importance of quality improvement programs in regulatory departments. Best practices for tracking metrics will be reviewed. Acknowledging the difficulties of implementing change, effective change management strategies that allow regulatory departments to work through process changes will be explored. The advent of AI and how it is affecting (if at all) regulatory groups will be examined.