Making an electronic common technical document (eCTD)-compliant submission to the FDA requires complex coordination of stakeholders and a detailed culmination of product information, providing the necessary information to FDA while also optimizing the submission package for ease of review. This presentation will cover the anatomy of an eCTD submission, starting with the structure of the eCTD backbone and its 5 modules, various applications of the eCTD format, the compilation process, validation, and submission to FDA using their electronic submissions gateway (ESG) WebTrader service. Additionally, the talk will cover common challenges, including information requests, validation errors, digital dataset files, submission navigation and readability, and document optimization.
Key Learning Objectives:
The purpose and function of the electronic Common Technical Document (eCTD)
How to prepare documents for eCTD submissions to FDA using PDF software and Lorenz docuBridge, including insights on how to avoid common errors and technical validation rejections
Publishing and validating your submission using Lorenz docuBridge and eValidator
Using the electronic submissions gateway (ESG) Webtrader submission portal to send eCTD submissions to FDA.
Who Should Attend:
Regulatory Affairs Professionals
Regulatory Affairs Operations Specialists
Quality Assurance (QA) Professionals
Compliance Officers
Clinical Research and Development Teams
Pharmaceutical Manufacturers
Quality Control (QC) Professionals
Clinical Operations Professionals
Antony Kaprielian | Senior Consultant – Regulatory Affairs Operations Manager
Antony leads the electronic publishing of all eCTD format applications to the desired agencies, maintains the lifecycle of submissions, and corresponds with regulatory agency project managers. He manages and authors applications to the regulatory agency, including but not limited to: Orphan Drug Designation (ODD), Investigational New Drug (IND) application, FDA Type A/B/C Meetings, Rare Pediatric Disease (RPD) Designation, Breakthrough Therapy Designation (BTD), Fast Track Designation (FTD), Qualified Infectious Disease Products (QIDP) Designation, and others. Antony also works with sponsors to develop regulatory strategy roadmaps and identify gaps in working submission packages.