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  5. Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness - June 19, 2018
  1. Development & Approval Process | Drugs

Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness - June 19, 2018

Image of SBIA Webinar 2016

Tuesday, June 19, 2018

10:00am - 2:00pm (Eastern)

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes 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 June 19, 2018 FDA provided an overview of Postmarketing Drug Safety Inspections for products regulated by the Center for Drug Evaluation and Research (CDER). These inspections include the Postmarketing Adverse Drug Experience (PADE) and Risk Evaluation and Mitigation Strategies (REMS) programs. During this extended webinar, we provided an overview of the relevant laws and regulations, described the PADE and REMS programs, and discussed points to consider for inspection.

This webinar has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant’s RAC recertification upon full completion. Only live attendance will qualify for the CE.
             (Attendance Certificates are only available for TWO WEEKS after the event)

Session One: Postmarketing Adverse Drug Experience (PADE) Inspections

Session Two: Risk Evaluation and Mitigation Strategies (REMS) Inspections

Session Three: Inspection Readiness


For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707

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