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

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

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

For Registration - http://www.complianceonline.com/us-fda-ectd-submissions-of-ind-and-nda-bla-seminar-training-80396SEM-prdsm?channel=eventzilla           

Note: Use coupon code < NB5SQH8N > and get 10% off on registration.