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CDER Small Business and Industry Assistance (CDER SBIA) | Webinar
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6/15/2017
When: 06/15/2017
12:00 PM - 3:00 PM
Where: Webinar
United States
Contact: CDER SBIA
(866) 405-5367

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Please visit https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm560108.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery for more information.

 

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This event is FREE
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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.
CDER invites you to our LIVE webinar: Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive to be held on June 15th from 12:00pm – 3:00pm (Eastern).

This extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:

Risk Evaluation and Mitigation Strategies - Purpose, Process, and Challenges
An overview of FDA-required Risk Evaluation and Mitigation Strategies (REMS) for certain high-risk drugs - the purpose they serve in ensuring the benefits of certain drugs outweigh their risks, the process of developing REMS programs, and the unique challenges of the requirement for a single, shared system for generics and brand products.

Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format: An Introduction
An introduction to the use of structured product labeling as a format for REMS information.  FDA will describe the history of the REMS SPL project, provide an introduction to SPL, and describe the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.

Speakers:
Elaine Lippmann, J.D.
Senior Regulatory Counsel
Office of Regulatory Policy
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Adam Kroetsch, MSPPM
Deputy Director (Acting)
Office of Program and Strategic Analysis
CDER | FDA

 

This webinar has been pre-approved by RAPS as eligible for up to 3 credits
towards a participant’s RAC recertification upon full completion.

Please note that the credit is only available for participation in the live 
            event and not for watching the recording afterwards.

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

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