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:
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) | ||
Session 1 (90 Mins):Introduction
Session 2 (90 Mins): Submission Structure and File Formating
Session 3 (90 Mins): Module 1 Administrative Information and Prescribing Information
Session 4 (90 Mins): Module 2: Summaries
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Session 5 (90 Mins): Module 3: Quality
Session 6 (90 Mins): Module 4 Nonclinical Study Reports
Session 7 (90 Mins): Module 5 Clinical Study Reports
Session 8 (90 Mins): eCTD Publishing, Validation and Submission.
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Meet Your Instructor
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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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