The filing of a major drug application for authorization to market is very much an art in management of people, time, and information. This presentation will capitalize on the presenter’s ongoing project management experience working as a regulatory program manager for numerous years at multiple sponsor companies. A single point of contact who will manage the submission planning process facilitates upfront appropriate planning, assemble of proper functional resources, assessment of risks and identified mitigations that allow for the most successful and timely submissions to global health authorities for a new marketing application. Starting with the regulatory strategy, detailing out the key components needed to support a submission, including health authority interactions and key deliverables, to development of a project plan that has enough detail to provide guidance to submission team without overstepping into the functional responsibilities. The use of visuals as a means of driving decision making, identifying risks, and managing core subject matter experts’ time. In parallel, there is a need to appropriately align the submission plan to the Dossier plan and work closely with the publishing team until the final document is ready and the dossier is submitted. As will be demonstrated, issues arise, but how the team manages these issues directly impacts the success of the filing. With a seasoned submission planning lead as part of a cross functional team working closely with regulatory, the odds of submitting on time with a solid and accurate submission dossier are increased.
Learning Objectives:
Recognize the value of effective planning.
Outline the requirements needed for an appropriate dossier.
Understand how effective team strategy alignment will help the overall submission goals.
