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DDI Webinar - REMS@FDA
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6/26/2018
When: June 26, 2018
1:00 PM -2:15 PM
Where: Webinar
United States
Contact:

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FDA’s Division of Drug Information is presenting a series of continuing education webinars targeting the needs of all health care professionals.

 

FDA Drug Topics:

FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS)

 

Will be held on:

June 26, 2018

Time: 1:00 pm to 2:00 pm (EDT)

 

To register for the online meeting, please visit: https://collaboration.fda.gov/ddi062618/event/registration.html

After registering, you will receive a calendar invitation with details on how to join the online meeting.

 

Activity Outline

Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will introduce health care professionals to web resources about Risk Evaluation and Mitigation Strategies (REMS), including a REMS resource portal and the REMS@FDA website, and will focus on what type of information is available, where, and how to navigate these resources.

 

Series Objectives:

  • Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care.

 

References:

  1. Food and Drug Administration. REMS@FDA website [Internet]. Silver Spring (MD); 15 Jun 2015. Available from: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
  2. Food and Drug Administration. REMS resource portal [Internet] Silver Spring (MD); 29 Jan 2018. Available from: https://www.fda.gov/Drugs/DrugSafety/REMS/default.htm.

 

Session Learning Objectives: After completion of this activity, the participant will be able to:

  1. Describe the web resource that defines a REMS and provides high-level descriptions of the roles of different health care providers in a REMS.
  2. Describe the web resource that provides a current listing of approved REMS and specifies the requirements of health care providers for each REMS.
  3. Locate additional REMS information and educational resources, as well as get answers to frequently asked questions.
  4. Summarize requirements for health care providers for the most recently approved REMS.
  5. Recognize how to provide feedback to FDA about these web resources.

 

Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students.

Schedule:

1:00 pm - 2:00 pm – FDA Drug Topics: FDA’s Web Resources Available to Healthcare Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS) presented by LDCR Amy Ramanadham, Senior Regulatory Research Officer, U.S. Food and Drug Administration, and Dr. Gary Slatko, Associate Director in the Office of Medication Error Prevention and Risk Management at FDA.

Continuing Education

Accreditation:

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.


CME

FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s). Physicians and physician assistants should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-18-027-L04-P, and ACPE Universal Activity Number JA0002895-0000-18-027-L04-T for 1.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1 contact hour.

 

Requirements for receiving CE Credit:

Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation survey via the CE Portal (ceportal.fda.gov). Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Pharmacy participants: partial credit cannot be awarded, therefore you must attend the entire activity to receive CPE credit. No exceptions. Pharmacists and pharmacy technicians will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving credit

Attendees have 14 days from the last day of the activity to log in, attest to your attendance, and complete the required evaluation survey, to claim credit. Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the activity to obtain their CE credit.

 

Registration Fees and Refunds: Registration is complimentary, therefore refunds are not applicable.

 

Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov.

 

To learn more about future dates and registration, please visit: www.fda.gov/DDIWebinars.

 

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