FDA Drug Topics: Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS) - November 28, 2023
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, November 28, 2023, CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS). This webinar will describe the Risk Evaluation and Mitigation Strategy (REMS) Integration Project, REMS structured product labeling (SPL), and the REMS Public Dashboard. The REMS integration project entails development of an open source, innovative, stakeholder-driven approach to use contemporary data standards and technologies for integration of REMS. The REMS SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology. The REMS Public Dashboard, launched in December 2021, was developed to improve access and transparency of REMS information. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. These innovative tools and initiatives are intended to support target users such as healthcare providers, patients, researchers, pharmaceutical companies, or regulators.
Register Here: https://fda.zoomgov.com/webinar/register/WN_ReDs5ma4T1ynu8pHHwRp4g
Download Presentation Slides: FDA Drug Topics: Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS) (PDF - 4.44 MB)
Activity Outline and Continuing Education Information