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.

This presentation is directed at the drug and biologics community. It will be particularly useful to the following:

  • Medical Officers
  • Operations Officers
  • Regulatory Affairs
  • QA/QR/QC
  • Information Technology

Antoinette Azevedo has offered electronic submission consulting since 1995 and eCTD publishing services since 2005. She assists firms of all sizes in all types of submissions on complying with the content and technical requirements of eCTD submissions — IND, DMF, ANDA, NDA and BLA.