eCTD Submissions of IND and NDA/BLA to the US FDA: 2-Day In-person Seminar

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.

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

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

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

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