eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
Date: May 27, 2025
Duration: 1 Day
Time: Starts at 10 AM EST
FDA now requires all DMFs be submitted only in the electronic CTD format which creates a huge burden on owners of most submissions. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. Our speaker, Dr. Mukesh Kumar, in this workshop will go over the details of the latest guidance on eCTD submission and explain the key takeaways.
Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
This one-day workshop is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools, eCTD software and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all electronic regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Soon FDA will stop accepting paper submissions of all kinds of applications. Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
This one-day workshop is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools, eCTD software and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all electronic regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Who Will Benefit:
- Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
- Medical and Technical writers
- Project Managers, Directors
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control
- IT professionals looking to make eCTD publishing and submissions
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Lecture 1
10:00 AM – 12:00 PM
FDA's Latest Guidance Documents
- The difference between CTD and eCTD
- FDA and ICH guidance documents
- Overview of a CTD: Modules 1-5
- Detailed explanation of the latest FDA guidance document
Ground Rules for Writing, Formatting and Updating Content
- Formatting and version control for content intended for electronic submission
- Using MS Office and Adobe elements to create e-ready documents
- Hyperlinks and cross-links in an XML environment
- Best practices for MS Word and Adobe PDF in an eCTD environment
- Off-the shelf software versus manual editing
Lecture 2
Module 1 of an eCTD
- Organization of Module 1
- IT & Regulatory Responsibilities
- Forms, certifications, and other components of Module 1
- Application fees, waivers, and correspondence
- NDA pre-submission number requests, secure email set-up
- National and multi-national applications
- Handling Amendments to M1
Module 2: Summaries in an NDA
- Descriptions of each section of Module 2
- Granularity requirements
- Cross-linking Module 2 with Modules 3-5
- Writing styles for summaries and review of information
- Use of Tables, lists, figures and flow-charts
- Handling Amendments to M2
12:00 PM – 12:45 PM: Lunch Break
Lecture 3
12:45 PM – 2:30 PM
Module 3: CMC Information Presentation
- Organizing the CMC information in an NDA
- Granularity and limitations of each section
- Minimum requirements for reports, testing data, and other documents
- Managing large files
- Content duplication and reference limitations
- Handling Amendments to M3
Modules 4 and 5: Bulk Data from Non-Clinical and Clinical Studies
- CTD/ICH format for study reports
- General organization of study reports in Modules, Study Tagging Files, Study Data Specifications
- Linking Module 2 with Modules 3 and 4: Micro-summaries verses Macro summaries
- Managing different PDF files: scanned verses de novo
- Cross-linking and hyper linking: pivotal verses non-pivotal studies
- Handling Amendments to M4 and M5
2:30 PM – 2:45 PM: Break
Lecture 4
2:45 PM – 4:15 PM
Putting the Whole Submission Together
- Cross-Referencing between Submissions
- Compiling the full eCTD, Submission Lifecycles, Singular vs. Grouped Submissions
- Validation of Submission Materials
- Acknowledgment and tracking submissions
Introduction to the FDA’s ESG
- What is the Electronic Submission Gateway (ESG)
- Submitting to the electronic document room versus ESG
- Stepwise instructions in creating an ESG account: Hardware and software, ESG Checklist
- Set-up, validation, and testing of ESG account
- Virus scanning requirements and uploading to ESG
- Direct versus Web-trader accounts
Register Online (By clicking on the links below)
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
