Course Description:

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:

  • 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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who Will Benefit:

  • Regulatory Affairs professionals preparing IND, DMFs, NDAs and other submissions
  • Medical and Technical Writers
  • Medical Researchers, PhD Students,
  • Project Managers, Directors
  • Supervisors, and Lead Workers in Regulatory Affairs
  • Quality Assurance and Quality Control
  • IT professionals looking to make eCTD submissions

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (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

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

Meet Your Instructor

Jaba Kokhreidze,
Scientific Consultant at JKMD Global Medical Solutions

Dr. Kokhreidze is Founder, CEO, and Chief Scientific Consultant for JKMD Global Medical Solutions, located in Orange County, CA. He consults on medical/regulatory affairs management and strategy, clinical R&D operations, research and clinical trials monitoring, protocol writing for clinical studies. He has 15 years experience in clinical medicine as a medical practitioner, researcher and a business executive. His clinical experience accounts 5 years in oncology as a surgeon, and 7 years in critical care medicine (ICU), Newport Beach, CA. He is U.S. (ECFMG) medical board certified and has both, US and European experience.

Dr. Kokhreidze also has an extensive biopharmaceutical industry experience. He was with British Pharmaceutical company, GlaxoSmithKline for 5 years, where he launched several brand name products on the market, including Oncology drugs; developed medical and regulatory strategies, and was a medical scientific liaison for a nationwide network of Key Opinion Leaders; he also represented the company at various scientific symposiums and government meetings.

Dr. Kokhreidze earned a Doctor of Medicine from Tbilisi State Medical University in 2000. He holds a Graduate Certificate in Clinical Trials: Drugs and Medical Device Product Development from University of California, Irvine. He received his MBA degree in Business Administration (Healthcare Administration and finance) from Northeastern University, Boston, MA, where he also earned a MSc in Regulatory Affairs for Drugs, Biologics and Medical Devices.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before 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 ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

We need below information to serve you better



6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method