Electronic Submissions to the FDA - eCTD Requirements

This webinar will be most beneficial to persons planning on writing and filing IND, NDA, ANDA, BLA applications to the US FDA; and to persons responsible for filing amendments to an existing paper IND. It will highlight summary of e-ctd requirements, format and content, how to prepare and file an IND application, how to do filing to an existing IND and best practices for IND submission.

Why Should You Attend:

The US FDA and International Council on Harmonization (ICH) have been transitioning from the use of paper documents to use of the electronic Common technical Document (eCTD) for drug development programs. As of May 2018 the FDA no longer accepts paper submissions for investigational or marketing applications and requires documents for a drug development programs be provided in eCTD format. The eCTD is a structured format that standardizes the contents of applications and requires the use of XMLs for table of contents and hyper-linking of each document in an application. This format is designed for electronic viewing and seamless navigation of the application.

Attend this webinar to gain current, expert, and ‘practical application’ knowledge about the electronic Common Technical Document (eCTD) structure and requirements for electronic submissions. Basic instructions on executing an electronic submission, or efficiently working with a vendor who can make submissions on the company’s behalf, will be reviewed.

Areas Covered in the Webinar:

• eCTD format and content
• eCTD applicable and not applicable types of submissions
• Summary of the requirements for electronic submissions
• Preparing and filing an electronic IND application
• Filing to an existing IND
• Good submission practices
• Common eCTD pitfalls

Who Will Benefit:

This webinar will be most beneficial to persons planning on writing and filing IND, NDA, ANDA, BLA applications to the US FDA; and to persons responsible for filing amendments to an existing paper IND.

It can also benefit senior management staff in biotech and pharmaceutical companies involved new drug development programs to gain an understanding of the electronic submission requirements and the level of work involved.