ComplianceOnline

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:

  • 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

Seminar Fee Includes:

Lunch
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.





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