Description
Are you currently preparing CTD submissions for the FDA and are familiar with the CTD structure, but need to learn how to comply with the May 2018 electronic submission requirements? Join this webinar.
Effective May 5, 2018 your company is required to migrate all commercial INDs and Master Files, as well as all NDAs, ANDAs, and BLAs to electronic-only regulatory submissions based on the required ICH eCTD format. The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications.
Objectives of the Presentation
- Identify best practices with software used to generate electronic submission content
- Understand the acronyms and terms surrounding eCTD and electronic submissions
- Apply ICH and regional requirements for the content of an eCTD submission
- Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
- Obtain an understanding of what is required to transition into submitting in the eCTD format
Why Should you Attend
Since May 2017, the eCTD is required in the U.S. for all marketing applications. Recently the FDA has extended the deadline for filing master files and all documents submitted to existing master files, in the electronic Common Technical Data (eCTD) format from May 5, 2017 to May 5, 2018. Any submissions not submitted electronically in eCTD format after the May 5, 2018 deadline will be rejected.
Join this session, where consulting expert, Peggy J. Berry, MBA, RAC, will provide you with the information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Areas Covered
- The drug development program and source of relevant submission documents
- The roles and responsibilities for CTD preparation
- The CTD format requirements
- Successful transition from other formats to the CTD
- How to implement tools for the project management of CTD preparation and publishing
- Technical requirements for an eCTD submission
- Document-naming requirements
- How to build the folder structure
- How to perform "pre-publishing" work for each document
- The tools for tracking and managing eCTD content
- How to perform quality checks on the eCTD
- How to update content in the CTD and eCTD (amendments, supplements, variations, etc.)
The speaker will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW) and give you a basic understanding how the regions differ.
Who will Benefit
- Regulatory affairs
- Quality assurance
- Pharmacovigilance
- Project management
- Regulatory operations
- Anyone responsible for providing content for the CTD
- Medical and Technical writers
- Professionals preparing IND, DMFs, NDAs and other submissions
- IT Professionals
For Registration
https://www.onlinecompliancepanel.com/webinar/Complying-with-FDA-s-Regulations-for-eCTD-Submissions-of-all-IND-s-NDA-s-Are-you-Ready-for-the-May-5-2018-deadline-506512/APRIL-2018-ES-EVENTZILLA
Note: Use Promo Code YDEZ6H and get 10% off on registration (Offer valid Till 30th April 2018)
