Different Approaches for Preparing a Marketing Application: A Review of Successful NDA/MAA Preparation Strategies
Veristat recently hosted a webinar titled " Different Approaches for Preparing a Markeitng Application: A Review of Successful NDA/MAA Preparation Strategies". View a recording of the webcast now.
- Amanda Truesdale, MA, MBA - Vice President of Biometrics, Veristat
- Kimberly Newton, Senior Director of Medical Writing, Veristat
- Martha Plaza, MBA, Project Director of Submissions, Veristat
Preparing your marketing application for one or more regulatory agencies is a very exciting time and milestone in the drug development process. However, it can be a very complicated and time-sensitive endeavor which is fraught with the coordination of many sequential and parallel activities and typically an immovable submission date/deadline. The most effective way to plan your submission timeline is to work backwards from your target submission date.
We will explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and how to work in coordination with the medical writing team so that they have all the information they need to write and complete the modules of the submission with adequate time for review and quality control. Additionally, we’ll discuss how to work effectively with other third-party vendors who are contributing to the submission and how to deal with delays in receiving data from an ongoing pivotal trial.
In the webinar, we will review actual case studies where we implemented completely different approaches for migrating data, performing analysis and writing the various modules of the marketing applications to achieve the submission deadlines. We even hit deadlines that the sponsor said couldn’t be hit.
If you don't have time to view the webinar replay, simply download a copy of the slides from the presentation: