eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar
"Listen From Peggy J. Berry she is President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development"
Assure compliance with CDISC requirements?
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).
Why should you attend:
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.
• 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?
• 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
Who will Benefit
• 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
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.