FDA has published final guidance that mandates a May 2017 deadline for all NDAs/BLAs/ANDAs/DMFs to be submitted in eCTD format. Exemptions from the mandate and deadline will not be granted commercial sponsors. In the meantime, the only electronic submission format accepted by FDA is eCTD and FDA is requiring eCTD in special cases ahead of the deadline.
Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.
- A trainer/consultant with years of real-world experience in filing DMFs/ASMFs in eCTD and non-eCTD electronic formats
- Review of the eCTD requirements of FDA, Health Canada, and EU
- Technical training on the use of MS Word and Adobe Acrobat to create files for eCTD submissions
- How to check for compliance of PDF files
- How to compile and verify compliance of eCTD submissions
Put yourself and your company a step ahead of competitors by mastering the technical skills needed to meet the impending electronic submission mandates. Several similar programs have sold out, so register today!
At the conclusion of this series, participants should be able to:
- List fundamental strategies for preparing eCTD submissions
- Explain the technical requirements of eCTD submissions
- Demonstrate best practices in the use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
- Decide and justify whether in-house publishing or outsourcing is the solution for submitting a US eCTD that is compliant with CDER and CBER requirements
Antoinette Azevedo founded e-SubmissionsSolutions.com to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting’s life sciences practice. Azevedo’s experience ranges from developing strategies for document management and electronic publishing, implementing fully validated systems, to staff augmentation and eCTD publishing services resulting in submissions accepted by regulatory authorities worldwide.