Burst CME: Regulatory Approval Pathways for Influenza Vaccines
Released On
October 28, 2022
Expires On
October 28, 2023
Media Type
Internet
Completion Time
30 minutes
Specialty
Geriatric Medicine, Infectious Disease, Primary Care, Family Practice
Topic(s)
Adult Vaccination, Geriatric Medicine, Influenza
Scroll to the Bottom of this Information to Begin this Course
This activity is provided by Physicians’ Education Resource®, LLC.
This activity is supported by an educational grant from Sanofi US.
Credit Available
- Physicians — maximum of 0.5 AMA PRA Category 1 Credits™
- Nurses — 0.5 Contact Hours
All other healthcare professionals completing this course will be issued a statement of participation.
Target Audience
This educational activity is directed toward geriatricians, primary care physicians, infectious disease physicians, internal medicine physicians, nurse practitioners, physician assistants, and nurses who manage older patients at risk for influenza.
Program Overview
This Burst CME: Regulatory Approval Pathways for Influenza Vaccines is an interview-based program in which an expert discusses the regulatory pathways for approval of influenza vaccines by the FDA. Licensure from the FDA of seasonal inactivated influenza vaccines may be sought through the submission of an application by means of either a traditional or accelerated pathway. To meet approval criteria with the traditional pathway, a manufacturer must demonstrate vaccine effectiveness against influenza in a randomized controlled trial that evaluates influenza illness as a primary end point. In contrast, the accelerated approval pathway for seasonal influenza vaccines may be preferred when a shortage of influenza vaccines exists in the US market. Accelerated approvals are based on adequate and well-controlled clinical trials establishing that a biologic product has an effect on a surrogate end point (eg, immunogenicity). Knowledge of the approval pathways for influenza vaccines helps clinicians to select vaccines and counsel their patients regarding vaccination against influenza.
Learning Objectives
- Upon completion of this activity, participants should be better able to:
-
- Define regulatory approval pathways for the licensure of influenza vaccines in the United States
Faculty
Jamie L. Wagner, PharmD, BCPS, BCIDP
Clinical Associate Professor of Pharmacy Practice
University of Mississippi School of Pharmacy
Jackson, MS
Accreditation/Credit Designation
Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Physicians’ Education Resource®, LLC, designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Physicians’ Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 0.5 Contact Hours.
Faculty, Staff, and Planners’ Disclosures
The staff of Physicians’ Education Resource®, LLC have no relevant financial relationships with ineligible entities.
Jamie L. Wagner, PharmD, BCPS, BCIDP, has no relevant financial relationships with ineligible companies.
PER® mitigated all COI for faculty, staff, and planners prior to the start of this activity by using a multistep process.
Instructions for Participation and Credit
- Complete the activity (including pre- and post-activity assessments).
- Answer the evaluation questions.
- Request credit using the drop-down menu.
You may immediately download your certificate.
Course Viewing Requirements
Supported Browsers:
Internet Explorer 8.0+ for Windows 2003, Vista, XP, Windows 7, Windows 8.1 and above
Google Chrome 28.0+ for Windows, Mac OS, or Linux
Mozilla Firefox 23.0+ for Windows, Mac OS, or Linux
Safari 6.0+ for Mac OSX 10.7 and above
Supported Phones & Tablets:
Android 4.0.3 and above
iPhone/iPad with iOS 6.1 or above
Off-Label Disclosure and Disclaimer
This activity may or may not discuss investigational, unapproved, or off-label use of drugs. Learners are advised to consult prescribing information for any products discussed. The information provided in this accredited activity is for continuing education purposes only and is not meant to substitute for the independent clinical judgment of a health care professional relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER® or any company that provided commercial support for this activity.