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  1. FDA Pharmacy Student Experiential Program

Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS)

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present our FDA Drug Topic series of educational webinars targeting the needs of all health care professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health professionals. 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) hosted a webinar titled: FDA Drug Topics: Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS). This webinar described 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.

Instructions for Learners to complete home study activities, complete evaluation, and print certificate:

  1. Navigate to https://ceportal.fda.gov/
  2. If you have an account, please login
  3. If you do not have an account, click on “Create an account!”
  4. Once you’re logged in, please complete your profile if you haven't done so already 
  5. Navigate to the “Web-based Courses” tab
  6. Select the activity you want to complete
  7. Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
  8. Begin the activity by clicking on the link at the bottom of the page
  9. After viewing the presentation, click on “Complete Post-test”
  10. After successful completion of the Post-test, click on “Complete Evaluation”
  11. After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion

Requirements for receiving CE credits:

Review the activity, complete the post-test and evaluation. Upon completion, learners may view or print their statement of credit.

For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor.  If you do not see your credit reflected on the CPE Monitor after 45 days after completion of the activity, please contact FDACETeam@fda.hhs.gov. The CPE Monitor sets a strict 60-day limit on uploading credits.

Initial release date: February 12, 2024
Expiration date: February 11, 2027

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