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 an overview of the development and federal regulations for vaccines in the United States. We will discuss key statutes that grants the Food and Drug Administration authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval. The basic vaccine development process and key regulatory milestones will also be covered.
References:
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Science and the Regulation of Biological Products - From a Rich History to a Challenging Future. US Food and Drug Administration, Center for Biologics Evaluation & Research. September 2002.
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Baylor, Norman and Midthun, Karen. “Regulation and testing of vaccines”, Chapter 73 in Vaccines, Fifth Edition. Plotkin, SA, Orenstein, WA, and Offit, PA. Philadelphia: Elsevier (2008).
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Shapiro, Stuart Z., The HIV/AIDS vaccine researchers’ orientation to the process of preparing a US FDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting. Vaccine 20:1261-1280, 2002.
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Federal Food Drug and Cosmetic Act (FD&C Act), June 25, 1938. Codified at 21 U.S.C. Ch. 9.
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Public Health Service Act, July 1, 1944. Codified at 42 U.S.C. Sec. 262.
- Code of Federal Regulations, Title 21, Food and Drugs, Parts 312 and 601 Washington, DC, Office of the Federal Register, National Archives & Records Administration, 2021.
Series Objectives:
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Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
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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:
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Identify the legislative Acts leading to and authorizing FDA to regulate preventive vaccines and discuss the historical context of each.
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List basic regulatory requirements and types of data needed to support vaccine licensure and marketing approval.
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Outline the usual vaccine development process from conception to marketing and explain key regulatory milestones during the process.
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: Development and U.S. Regulations of Preventive Vaccines presented by CAPT Julienne Vaillancourt, Policy Advisor and Rare Disease Liaison in CBER’s Office of the Director.
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.
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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.
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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 JA0002895-0000-22-073-L03-P. and ACPE Universal Activity Number JA0002895-0000-22-073-L03-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.
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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:
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Vaillancourt, Julienne, MPH, RPh, Rare Disease Liaison/Policy Advisor, FDA/CBER/OD – nothing to disclose
Planning Committee:
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Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
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Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose
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DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
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Kapoor, Rama, MD, Medical Officer, FDA/CDER/OND/OID/DAI - nothing to disclose
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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:
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Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
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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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