eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Duration: 90 Minutes
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).
Objectives of the Presentation
Why Should you Attend
- What are the requirements for electronic datasets in eCTD submissions?
- Where are the contents of clinical datasets located in the eCTD structure for: tabulation datasets, analysis-ready datasets and programs, and patient profiles?
- What approaches should be taken to assure submission-readiness of datasets?
- How can the datasets package be remediate for submission if the deliverables are not submission-ready?
- What is the impact of CDISC and what steps should be taken now to assure compliance with CDISC requirements?
- What steps should be taken if electronic datasets are not available?
Despite there being extensive information available from FDA and other regulatory bodies regarding eCTD submission, creating one and submitting it through the electronic submission gateway (ESG) of the FDA, is a daunting task even for those proficient in computer systems and coding languages. The off-the-shelf software and consultations available are prohibitively expensive not only in the capital investment required but also in terms of the time needed for getting a submission ready.
This webinar is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts.
The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions.
Who will Benefit
- Overview of the drug development program and source of relevant submission documents
- Discussion of the roles and responsibilities for CTD preparation
- Review of the CTD format requirements
- Discussion on the successful transition from other formats to the CTD
- Implementing tools for the project management of CTD preparation and publishing
- eCTD Guidance and Specifications, FDA
- FDA, submission guidance and requirements
- Technical requirements for an eCTD submission
- Performing "pre-publishing" work for each document
- Tools for tracking and managing eCTD content
- Performing quality checks on the eCTD
- Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
- Different requirements in regions ( US, EU and Canada)
- Regulatory Affairs
- Quality Assurance
- Project Management
- Regulatory Operations
- Medical and Technical writers
- Professionals preparing IND, DMFs, NDAs and other submissions
- IT Professionals
- Anyone responsible for providing content for the CTD