Activity Outline Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, 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. Expanded Access (EA) is use of an investigational drug or biologic to treat a patient with a serious disease or condition who does not have comparable or satisfactory alternative therapies. This webinar will provide an overview of FDA's EA Program and introduce participants to resources like the EA eRequest site hosted by the Reagan-Udall Foundation for the FDA. The EA eRequest site enables physicians to prepare and sign EA requests and submit those requests securely to FDA. References: 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. Learning Objectives: After completion of this activity, the participant will be able to: - Explain the primary purpose of Expanded Access and how it differs from clinical trials.
- Distinguish between emergency and non-emergency Expanded Access requests for individual patients.
- Identify useful resources for preparing Expanded Access requests for individual patients.
Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students. Schedule: 1:00 pm - 2:00 pm – FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site presented by Jacqueline Corrigan-Curay, JD, MD, Principal Deputy Center Director in FDA's Center for Drug Evaluation and Research (CDER), along with Lori Bickel, JD, Regulatory Counsel with the Office of Medical Policy in CDER, and Lea Ann Browning-McNee, MS, Director of Communication and Stakeholder Engagement at the Reagan-Udall Foundation for the 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 JA0002895-0000-21-037-L04-P, and ACPE Universal Activity Number JA0002895-0000-21-037-L04-T for 1.00 contact hour(s). CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).  AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation. | CPH
Up to 1.00 CPH Recertification Credits may be earned at this event. 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. Attention Pharmacists and Pharmacy Technicians: Failure to provide your correct NABP and Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721). Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct. 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. Disclosure: Faculty: - Bickel, Lori, JD, Regulatory Counsel, FDA/CDER/OMP/DMPD - nothing to disclose
- Browning-McNee, Lea Ann, MS, Director, Stakeholder Engagement & Communication, Reagan-Udall Foundation for the FDA - nothing to disclose
- Corrigan-Curay, Jacqueline, MD, JD, Director Office of Medical Policy, FDA/CDER/OCD/OMP – nothing to disclose
Planning Committee: - Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose
- DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
- Kapoor, Rama, MD, Medical Officer, FDA/CDER/OND/OID/DAI - nothing to disclose
- Nguyen-Chu, Thanh Tam, PharmD, BCPS, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Paraoan, Dianne, MPH, RN, Associate Director for Regulatory Affairs, FDA/CDER/OMP - nothing to disclose
CE Consultation and Accreditation Team: - Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
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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