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FDAのDrug Registration and Listing Workshop Webcast

2020年10月8日 @ 8:00 AM - 5:00 PM EDT

FDADrug Registration and Listing Workshop Webcastに無料で参加できます。

 

FDACDER Drug Registration and Listing Registration

Drug Registration and Listing Workshop

October 8, 2020 | Webcast

This workshop is FREE.


REGISTER


Join registration and listing staff in this workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. Ask questions to FDA subject matter experts.

INTENDED AUDIENCE

  • Regulatory affairs professionals working on registration and listing submissions
  • U.S. Agents
  • Importers
  • Manufacturers, repackagers, relabelers, and private label distributers
  • Submission vendors

TOPICS COVERED

  • Labeler Code Requests
  • Establishment Registration
  • Drug Listing
  • 503B Compounder Product Reporting using CDER Direct
  • Establishment Registration and Drug Listing Compliance Program 
  • All sessions include a Q&A panel

REGISTER


CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

 

詳細

日付:
2020年10月8日
時間:
8:00 AM - 5:00 PM EDT
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