FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. This webinar will provide an overview of the TRC and walk through resources currently available to help the sponsor/applicant determine if their submission is subject to these eCTD validations, creation of a simplified TS.XPT, and frequently asked questions. INTENDED AUDIENCE - Regulatory affairs professionals
- Consultants working on eCTD submissions containing study data
- Statisticians and statistical programmers
This webinar is FREE. | | TOPICS - Technical Rejection Criteria (TRC) Background and What's New
- Overview of the TRC and Effective Date
- TRC Warning Metrics
- CDER SEND Requirements and TRC
- Preparing a Study Using the Self-Check Worksheet
- Creating a Simplified TS.XPT File
- Frequently Asked Questions
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