lunes, 14 de noviembre de 2016

FDA Webinar: Electronic Submission Requirements for ANDAs: Are You Ready? - November 21, 2016


On November 21, 2016, 1 PM (Eastern), FDA's Center for Drug and Evaluation Research Small Business & Industry Assistance (CDER SBIA) program will host a LIVE webinar titled:
This webinar is an opportunity to learn about the new electronic submission requirements and ask FDA questions. During the webinar we will provide information regarding the requirement that all ANDA 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.
  • Common eCTD deficiencies
  • Changes in how OGD will handle eCTD deficiencies starting May 5, 2017.
We are very interested in addressing any questions or concerns and we 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 credit towards a participant’s RAC recertification upon full completion.
For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707
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