Free 1-hr "Live" CME/AAPA/CNE/CPE/CPT/CPH Webinar on: FDA Oncology Center of Excellence's Project Facilitate - An Overview of the Oncology Expanded Access Program sponsored by the Division of Drug Information

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 Oncology Center of Excellence's Project Facilitate - An Overview of the Oncology Expanded Access Program Will be held on: October 29, 2019 Time: 1:00 PM to 2:00 pm (EDT) To register for the online meeting, please visit: https://collaboration.fda.gov/ddi102919/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, 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. This webinar will provide a high-level overview on Expanded Access and address the roles of oncology healthcare providers in the submission of an Expanded Access Request. The webinar will also introduce the newly launched Project Facilitate of the Oncology Center for Excellence and explain its role in supporting oncology health care providers utilizing the Expanded Access pathway. 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: Lemery, S., Mailankody, S., Kazandjian, D., Demiette Smit, M., Blumenthal, G., Kim, T., Keegan, P., McKee, A., Pazdur, R. (2016, June). Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014). Abstract accepted and poster presented as American Society of Clinical Oncology Annual Meeting, Chicago, IL. Reagan-Udall Foundation (n.d.). Expanded Access Navigator. Retrieved from https://reaganudall.org/.  Learning Objectives: After completion of this activity, the participant will be able to: Define expanded access and the key requirements for an expanded access request for an individual patient. Summarize key responsibilities of the oncology healthcare provider when considering expanded access for a patient. Identify resources available to healthcare professionals considering submission of an oncology expanded access request for an individual patient. 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: FDA Oncology Center of Excellence’s Project Facilitate: An Overview of the Oncology Expanded Access Program presented by Natasha Kormanik, MSN, RN, OCN, Regulatory Health Project Manager in OHOP/DHP and Mitchell Chan, PharmD, BCPS, Regulatory Health Project Manager in OHOP/DOP1.

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 JA0002895-0000-19-020-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-020-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. Pharmacy participants: 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. Disclosure: Faculty: Chan, Mitchell, PharmD, BCPS, Regulatory Health Project Manager, OHOP/DOP1 - I received stocks from TEVA Pharmaceuticals. Divested stock in 2019. Kormanik, Natasha, MSN, RN, OCN, Regulatory Health Project Manager, OHOP/DHP - 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 Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose Weinstein, Edward, M.D., Ph.D., Medical Officer, CDER FDA - My spouse received salary from EndoCentre of Baltimore for a role as employee.  CE Consultation and Accreditation Team: Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, 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