CDER SBIA Webinar: Electronic Submission of DMFs is MANDATORY starting May 5, 2017: What You Need to Know – 8/4/16

On August 4, 2016, 1 PM EST,

CDER will host a LIVE webinar titled:

"Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know."

 Only 10 months until all DMFs must be submitted in electronic format!

This 90 minute webinar will provide information regarding the new requirement that all DMFs must be submitted in electronic Common Technical Document (eCTD) format starting May 5, 2017. The presentation will address issues such as:

- What are the eCTD specifications?

- Where to find helpful how-to materials on eCTD submissions? –

- Tips for successful submissions. -

We are very interested in addressing any challenges or issues that you may have on this subject and will have a live Q and A session after the presentation.

 This event has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

 Resources:

- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications -
- The eCTD website -

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For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

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