Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy

Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy (REMS)
In this FDA Drug Topics Continuing Education webinar, Dr. Ed Milliken will be providing a high level overview of the Room structured Product Labeling SPL and how it pertains to the REMS integration project. George Neyarapally will provide an overview and update of the progress of the REMS integration project and Gita Toyserkani will be discussing the REMS public dashboard and its capability.
Chapters
0:00 - Introduction and Welcome Remarks
4:47 - Edward Millikan
16:36 - George Neyarapally
30:11 - Gita Toyserkani
42:05 - Questions and Answers
Resources:
HL7 CodeX FHIR Accelerator. REMS Integration Use Case. Available at: confluence.hl7.org/display/CO... (Accessed on September 22, 2023).
George A. Neyarapally, Ed Millikan, Claudia Manzo. Implementation and Integration of Risk Evaluation and Mitigation Strategies into the Health Care System. Appl Clin Inform 2023;14:354-355.
U.S. Food and Drug Administration. (2023). REMS Document Technical Conformance Guide (Version 1.0). Available at: www.fda.gov/regulatory-inform... (Accessed on September 22, 2023).
U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard Website: www.fda.gov/drugs/risk-evalua....
U.S. Food and Drug Administration. REMS@FDA. www.accessdata.fda.gov/script....
Toyserkani, G.A., Lee, J.H. & Zhou, E.H. The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. Pharm Med 37, 349-353 (2023). doi.org/10.1007/s40290-023-00...