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Home » Store » Webinar Recordings » eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

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eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

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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.

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