Training Course Syllabus:

eCTD Submissions of IND and NDA/BLA to the US FDA

This course will introduce you with a current thinking of the Food and Drug Administration (FDA or Agency) on the topic and provide you with useful specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

After completing this, hands on two- day seminar, you will become familiar with all guidelines and regulatory requirements governing the electronic common technical document (eCTD), necessary for IND, NDA and BLA submission..

Days of the color - coded binders are over. FDA is transitioning towards electronic version of common technical document as an only acceptable submission format for IND, NDA and BLA applications. eCTD is a harmonized format of market authorization, developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is adopted by regulatory bodies around the world.

This two day seminar will address the technical challenges associated with creating the eCTD and will help you to navigate through essential elements and regulatory requirements for publishing and successfully submitting eCTD through the electronic submission gateway (ESG) of the FDA. During this two-day hands on workshop, trainers will use FDA/ICH guidelines and case studies to deliver handful practical tips and help you to master the minimum required skills necessary for preparing a successful eCTD submission.

Areas Covered:
IND, NDA, BLA
eCTD
CTD vs eCTD
Acceptable document formatting
Rejections
IT role in eCTD publishing and submission
Modules 1 to 5 of eCTD
FDA and ICH guidelines
Q&A

Course Outline:
Day 1 (8:30 AM – 4:30 PM)

8:30 – 9:00 AM: Registration
9:00 AM: Session Start Time

Session 1 (90 Mins):Introduction

General overview of IND, NDA, BLA
Introduction to eCTD
Types of Submissions That Must Adhere to the Electronic Submission Requirement Described in This Guidance Document
Timetable for Implementation of Electronic Submission Requirements
Types of Submissions That Are Exempted From the Electronic Submission Requirement Described in This Guidance Document
The eCTD Specifications

Session 2 (90 Mins): Submission Structure and File Formating

Pre-Submission Considerations
Document Granularity, Files, and Folders
File Formats and Versions, Common Formats
Document Lifecycle and management
XML Based eCTD
eCTD backbone file (index-md5.txt)
Crosslinks and hyperlinks

Session 3 (90 Mins): Module 1 Administrative Information and Prescribing Information

Introduction
Region Specific Information: Module 1
Submission Addresses
Media
Cover Letter
Transport and Security

Session 4 (90 Mins): Module 2: Summaries

Introduction
Quality overall summary
Nonclinical Overview
Clinical Overview
Nonclinical Written and Tabulated Summaries
Clinical summary

Day 2 (8:30 AM – 4:30 PM)

Session 5 (90 Mins): Module 3: Quality

Introduction
File organization
Body of Data
Chemistry Manufacturing and Control files

Session 6 (90 Mins): Module 4 Nonclinical Study Reports

Introduction
Folder hierarchy for module 4
File names and organization

Session 7 (90 Mins): Module 5 Clinical Study Reports

Introduction
Folder hierarchy for module 4
File names and organization

Session 8 (90 Mins): eCTD Publishing, Validation and Submission.

Introduction
Electronic Submission Gateway (ESG)
Obtaining a Test Account
Obtaining a Production account
Obtaining pre-submission approval
Digital Certification
Tracking the submission
Accessing MDNs and Acknowledgements

Seminar Summary:

This course will introduce you with a current thinking of the Food and Drug Administration (FDA or Agency) on the topic and provide you with useful specifications, recommendations, and general considerations. (see full course description)

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