Electronic Submissions to the FDA - eCTD Requirements

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.

Olga Pavlova
Regulatory Manager, Amarex Clinical Research, LLC

Olga Pavlova, PhD, Regulatory Manager; Dr Pavlova is one of Amarex’s leading regulatory experts. She has written all sections of applications for IND, NDA, ANDA, BLA, IDE, PMA and ODD. Her experience includes writing IND submissions and regulatory documents; Investigator Brochures, annual reports, and clinical protocols. Dr Pavlova conducts gap analyses of product development programs which are then used to create FDA regulatory approval strategies in a wide range of therapeutic indications for small molecule drugs, biologics and devices. Before joining Amarex Dr. Pavlova gained experience in developing portfolio strategy, due diligence and invention marketing while doing an internship at The Center for Advancing Innovation, Inc. Dr Pavlova has over nine years of research experience in the area of molecular biology, microbiology and biochemistry.

Dr. Pavlova completed her graduate work at the Institute of Gene Biology, Russian Academy of Sciences and the Waksman Institute of Microbiology, Rutgers University, NJ and earned her PhD degree in Biology. She completed her postdoctoral work on food borne pathogenic bacteria virulence factor secretion at the National Institutes of Health, Bethesda, MD. She also earned her Masters degree in Biochemistry from the Moscow State University, Moscow, Russia.

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