eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript
eCTD Submissions — What You Need to Know to Comply with FDA Requirements: Best Practices for Pharmaceutical Regulatory Professionals
Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it.
The time to prepare is now.
You’ll discover what you need to know in 90 minutes flat:
- How to avoid an RTR
- Implementation roadmap: implementing the technical and organization components for eCTD success
- Not spending a fortune: Best practices and options for producing your eCTD economically
- Impact on CMO and CRO partners: How the eCTD format may affect them
- Impact on other regulatory bodies: How the eCTD format may play in the EU and elsewhere
- And MUCH more!
The FDA has twice extended the deadline to start filing via eCTD, in recognition of the complexity entailed by this new process. A third extension is not likely. Discover what you need to know now.