Submitting INDs in eCTD Format: Master Compliant Drug and Biologic Submissions
Product Details
The Center for Drug Evaluation and Research (CDER) now requires that an investigational new drug (IND) application that's being submitted electronically must be in electronic common technical document (eCTD) format.
Preparing and submitting an IND to CDER in eCTD format comes with many unique challenges such as:
- An IND submission is provided over a longer period of time than other submissions and requires a more comprehensive plan
- Data from the IND stage can be used and presented in ways later on that weren't initially planned
- The presentation of preclinical/nonclinical study data
- The point at which you should establish communication with the FDA in preparation for an eCTD submission
Don't risk an RTF letter ... find the actionable information you need to meet all the challenges and properly file these submissions.
Let eCTD expert Antoinette Azevedo show you the steps you need to prepare and submit an IND in eCTD format during this 90-minute Encore presentation. She'll explain the folder structure and content format for the document along with the navigation backbone standards. And she'll explain the FDA's perspective on INDs in eCTD format.
Antoinette will deliver the tips and tricks you need to master eCTD submission requirement.
Sign up your entire team to listen in and discover:
- How an IND maps to the eCTD table of contents
- The benefits gained by sponsors who submit INDs electronically when in the process of transitioning to the process of submission of marketing applications (NDAs and BLAs)
- The folder structure, document content format and navigation backbone standards
- How to prepare compliant source documents and datasets for eCTD submissions
- What the FDA's perspective is on INDs in eCTD format
Register now and you'll have all the steps you need to take when preparing and submitting an IND in eCTD format. Plus, you'll get a chance to ask questions during the Q&A session.