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.
In this webinar, featured speakers 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, 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 also review actual case studies where they implemented completely 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.
Amanda Truesdale, MA, MBA, Vice President of Biometrics, Veristat
Amanda Truesdale is the Vice President of Biometrics at Veristat and in this role leads the Biostatistics, Statistical Programming, Data Management, and Standards Programming functions. Amanda helps guide clients through the complex process of analysing clinical trial data to make smart clinical, regulatory and business decisions. Her expertise in planning and performing data conversion and analysis for marketing applications comes from her direct involvement in 16 regulatory submission projects and oversight of many others.
She earned her MBA at Bryant University in North Smithfield, RI and earned both her MA and BA degrees in Mathematics and Statistics from Boston University in Boston, MA.Message Presenter
Kimberly Newton, MA, Senior Director of Medical Writing, Veristat
Kimberly Newton is the Senior Director of Medical Writing and oversees the medical writing team and develops project-specific strategies to increase the team’s productivity and quality. Kimberly has nearly 25 years of regulatory affairs and medical writing experience across multiple large and mid-sized CROs. Over the course of her career, she has worked as a medical writer, she has led global medical writing teams, and she has supported countless medical writing projects for clinical trials and regulatory submissions. Kimberly has contributed to the writing of more than 20 Investigational New Drug Applications (INDs) and worked on over a dozen marketing applications
She earned her MA in English Literature at North Carolina State University and her BA in English at the University of North Carolina at Chapel Hill.Message Presenter
Martha Plaza, MBA, Project Director of Submissions, Veristat
Martha Plaza, MBA, Project Director of Regulatory Submissions at Veristat is a clinical project management and regulatory submissions expert. She oversees or directly manages the planning, preparation of and execution of regulatory submission projects for Veristat’s clients. She has supported over a dozen regulatory submission projects in her time at Veristat.
Martha has over 30 years of experience working as a project manager as well as leading project and clinical operations teams for multiple international and national CROs. She earned her MBA in Operations Management at the University of Cincinnati in Cincinnati, and her BS in Biology at Manhattan College in Riverdale, NY.Message Presenter
Who Should Attend?
Small to mid-size biopharmaceutical firms.
Relevant job titles include:
- Head, VP, Directors of Regulatory Affairs
- Head, VP, Directors of Medical Writing
- Head, VP, Directors of Biometrics or Biostatistics & Statistical Programming
- Data Standards Conversion
What You Will Learn
- How to plan and adjust your submission timeline
- How to deal with delays (could be from vendors, agencies, etc) and still achieve timelines
- Explore a few case studies to illustrate differing approaches for migrating and analyzing data without causing downstream medical writing delay
Veristat is a smart, effective and impactful clinical research organization (CRO) that helps biopharmaceutical firms design, build, and run their clinical development programs and navigate the regulatory submission process. Veristat provides experience-based strategic decision-making consulting, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze & report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to mastermind the entire process.