Preparing Compliant eCTD Submissions
Instructor:
Antoinette Azevedo
Product ID: 700719
- Duration: 60 Min
FDA has issued Refuse-to-File (RTF) notices to sponsors who submitted noncompliant eCTDs, which resulted in sharp drops in market capitalization of those sponsor’s companies, months of time and effort to prepare the eCTD for resubmission, and potentially millions in dollars of lost revenue from overall delays in FDA review.
Areas covered in the webinar:
- Understand requirements for electronic submissions -- eCTD, SPL/PIM, CDISC.
- Understand how the agencies perform reviews on electronic submissions.
- Evaluate your company's technical resources (software, network, document management) to prepare eCTD submissions.
- Evaluate your company's business policies concerning records management and document management and their impact to preparing eCTD submissions.
- What approaches can you take to prepare eCTD submissions including outsourcing all or part of the process?
- How to validate compliance of your eCTD with FDA and ICH guidances?
Who will benefit:
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products. The employees who benefit include:
- Regulatory Affairs strategists
- Regulatory Operations
- Information Technology managers and personnel
- Quality, Nonclinical and Clinical staff managing deliverables from internal and external suppliers that will make their way into eCTD
- Medical writing
Antoinette Azevedo, founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies -- all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.
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