Press Release (ePRNews.com) - Toronto, ON - Jun 05, 2018 - Preparing your marketing application for one or more regulatory agencies is an exciting milestone in the drug development process. However, it can be a complicated and time-sensitive endeavor which is fraught with the coordination of many sequential and parallel activities and typically an immovable submission date/deadline.
In this live webinar, featured speakers from Veristat, Amanda Truesdale, MA, MBA, Vice President of Biometrics, Kimberly Newton, MA, Senior Director of Medical Writing and Martha Plaza, MBA, Project Director of Submissions, 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 they have all the information needed to write and complete the modules of the submission with adequate time for review and quality control. Additionally, the speakers will 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.
The speakers will review actual case studies where they implemented different approaches for migrating data, performing analysis and writing the various modules of the marketing applications to achieve the submission deadlines. They even hit deadlines that the sponsor said couldn’t be hit.
Join this interactive and informative presentation on Wednesday, June 13, 2018 at 12pm EDT (5pm BST/UK).
For more information about this complimentary event, visit: Different Approaches for Preparing a Marketing Application: A Review of Successful NDA/MAA Preparation Strategies
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