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  5. CDER Small Business and Industry Assistance (CDER SBIA) Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - August 4, 2016
  1. CDER Small Business & Industry Assistance (SBIA)

CDER Small Business and Industry Assistance (CDER SBIA) Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - August 4, 2016

NOTE: On April 7, 2017 the FDA announced that it is extending the compliance date for submitting DMFs in eCTD format to May 5, 2018. These webinars were created prior to April 7, 2017 and have the incorrect DMF compliance date.

SBIA Webinar 2016

 

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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our 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 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.
 
The featured speakers will be:
 
Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP) | CDER
 
Arthur Shaw
DMF Expert, Review Chemist
New Drugs Products Branch IV (NDBIV),
Division of New Drug Products (DNDPII)
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ) | CDER
 
Panelists (including above speakers)
Ginny Hussong
Director
Division of Data Management Services and Solutions
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP), CDER
 
Mark Gray
Senior Project Manager
Center for Biologics Evaluation and Research (CBER)
 
 
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:

 
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
 
If you've never used Connect Pro, get a quick overview: http://www.adobe.com/go/connectpro_overview
Test your connection prior to the day of the event: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
 
Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

 

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