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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Topics in Public Health: President’s Emergency Plan for AIDS Relief (PEPFAR) – The Basics
December 13, 2019
Webinar

Activity Coordinator:
Ashlee Janusziewicz (Ashlee.Janusziewicz@fda.hhs.gov)
Series Description

This series will educate PHS health professionals about topics that are pertinent to their roles within the various agencies within the Department of Health and Human Services and other Public Health Service agencies by presenting topics that directly relate to the HHS Strategic Plan, the Secretary's Strategic Initiatives, current topics for DHHS OPDIVs who utilize PHS health professionals, and/or other topics directly related to the advancement of public health.  

Lecture Description
The goal of this seminar is to educate the audiences to have a better understanding of the importance of the PEPFAR program (the US President's Emergency Plan For AIDS Relief known as PEPFAR is a government initiative to help save the lives of those suffering from HIV / AIDS), its goals, and how generic drugs are approved and handled for products listed under this program, in which providing HIV meds around the world saving over 11.5 million lives with HIV & reducing 96% transmission to partners.
References
  • Chahal HS, Murray JS, Shimer M, Capella P, Presto R, Valdez ML, Lurie PG. The US Food and Drug Administration’s tentative approval process and the global fight against HIV. J Int AIDS Soc. 2017 Dec; 20(4).
  • U.S. State Department. The United States President’s Emergency Plan for AIDS Relief. [cited 2019 Oct 7]. Available from: https://www.state.gov/pepfar/.
Series Objectives
  • Describe scientific evidence supporting the HHS Initiatives, Surgeon General Priorities or any other public health concern
  • Explain the multi-disciplinary approach in addressing public health issues
  • Identify public health concerns.
  • Identify ways Public Health Professionals can impact public health issues.
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe the PEPFAR program and how the program is running.
  • Summarize the process by which FDA’s Office of Generic Drugs (OGD) approves medications under this program.
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other public health medical professionals interested in learning more about the initiatives and other advances in public health.
Agenda

Lecture 1 December 13, 2019
Time Topic Speaker
2:00 - 3:00 PM EST President’s Emergency Plan for AIDS Relief (PEPFAR) – The Basics Tina Nhu, PharmD, R. Ph
Continuing Education Accreditation
Jointly Accredited Provider
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.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 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 1.00 AMA PRA Category 1 Credit(s). Physicians 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 JA0002895-0000-19-014-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-014-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).
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: 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, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Nhu, Tina, PharmD, R. Ph, pharmacist, fda - nothing to disclose

Planning Committee
  • Alu, Susan, Pharm.D., Clinical Pharmacist, U.S. Public Health Service - nothing to disclose
  • Begansky, Stephanie - nothing to disclose
  • Birch-Smith, Postelle, PharmD, Lead CSO, FDA - nothing to disclose
  • Brodhead, LeAnn, PharmD, Health Insurance Specialist, CMS - nothing to disclose
  • Camilli, Sara, PharmD, BCPS, Associate Director, FDA/CDER/OSE/DPV II - nothing to disclose
  • Chin, Edward, MD, MPH, Medical Officer, ONDP II - nothing to disclose
  • Janusziewicz, Ashlee, Pharm.D, Compounding Incidents Team Leader, FDA/CDER/OC/OUDLC - nothing to disclose
  • La, Thang, PharmD, MPH, Central Triage Unit Manager, FDA/CDER/OSE/RSS - nothing to disclose
  • Leung, Tamy, PharmD, MPH, BCPS, Accountable Care Organization Coordinator, Centers for Medicare and Medicaid - nothing to disclose
  • Lucero, Karly, RN, DNP, MSN/eD, CCHP, Regional Field Medical Coordinator, DHS - nothing to disclose
  • McClain, Rena, PharmD, Health Insurance Specialist, CMS - nothing to disclose
  • Nabavian, Sadaf, PharmD, Senior Regulatory Project Manager, FDA - nothing to disclose
  • Wagner, Lindsay, PharmD, BCPS, Branch Chief, FDA - nothing to disclose
  • khatri, Sadhna, PharmD, MPH, MS, MEd, Program Coordinator, FDA/CBER/OCBQ/DCM/APLB - nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., 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 Information
Registration is complimentary; therefore refunds are not applicable.