CDER SBIA Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
CDER SBIA Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
CDER SBIA is pleased to launch our 2016 webinar series. These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
On February 4, 2016, 1 PM EST, CDER will host a LIVE webinar titled:
"New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know.”
This 75 minute live webinar will provide information regarding the new requirement that all DMF Submissions 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 submission
Resources:
The Final Binding eCTD Guidance
The eCTD website
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
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