Golimumab Risk Evaluation and Mitigation Strategy: Embarking and Executing on the New Era in Drug Safety

Time

Tue, Jun 26 11:00AM
T 17

Title

Golimumab Risk Evaluation and Mitigation Strategy: Embarking and Executing on the New Era in Drug Safety

Abstract Summary

FDA may require manufacturers to implement REMS,if they determine that a REMS is necessary to ensure benefits of the drug or biological product outweigh the risks of the medication.REMS elements include medication guide, communication plan, elements to assure safe use, and implementation plan.

Poster Presenter

Ralph J. Dehoratius
MD, FACP,
Director,
Janssen Biotech Services
United States

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