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Session 11 Track 2: Optimizing Submission Filings: Understanding the Challenges and Developing Strategies Accelerating Submission Delivery to Health Authorities

Panelist: Rachel Bombara


Regulatory Services Manager

Publishing with a Global Mindset: Do’s & Don’ts of Re-using Documents across eCTD Applications
eCTD Modules 2 through 5 are designed to be common across application types and regions, however, often there are many changes needed to these sections when they are submitted to different health authorities. This presentation will discuss the varying requirements of health authorities for eCTD applications, explore the areas where changes are often required in modules 2-5, and recommend proactive publishing strategies for mitigating re-work if a document will be submitted to multiple regions.  Real-world examples will be cited as well as high-level tips to keep in mind when planning publishing activities for long-term projects.