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CE Credits Available for this Activity: 1
Program Overview: The purpose of this activity is to educate medical professionals who would like to learn about the FDA’s organization and regulatory roles in medical product development, highlighting key submission types and unique considerations for pediatric clinical therapeutics..
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to understand the FDA’s structure, its regulatory role in medical products, and the unique considerations for pediatric clinical trials, covering key regulatory submissions like INDs, IDEs, NDAs, BLAs, and PMAs.
Objectives
Understand the FDA’s organization and role in regulating medical products, including drugs, biologics, and medical devices, and the mission, vision, and core functions of the FDA’s Office of Pediatric Therapeutics.
Differentiate INDs, IDEs, NDAs, BLAs, and PMAs and understand the FDA’s role generally in the medical product development lifecycle.
Highlight the appreciation of the unique regulatory considerations that apply to pediatric clinical therapeutics trials.
References
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-prepared-and-submitted-sponsor-investigators
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-decisions-investigational-device-exemption-clinical-investigations
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinical-investigations-medical-products-involving-children
Faculty Disclosure
The following planners, speakers, moderators, peer reviewers, and/or panelists of this CE activity have financial relationships with ineligible companies to disclose:
Sherry Courtney, MD – Consultant: Aerogen Pharma
All financial relationships have been mitigated.
No other planners, speakers, and/or peer reviewers of this CME activity have relevant financial relationships with ineligible companies to disclose.
The compliance reviewer, Courtney Bryant, Sara Hale, or Brandie Jones, has no relevant financial relationships with ineligible companies to disclose.
Planners: Sherry Courtney, MD; Song Ounpraseuth, PhD; Lora Lawrence, RN; Catrice Banks-Johnson, MPA; DeAnn Hubberd, MA
Speaker(s): Amanda Staiano, PhD, MPP
Speaker(s) Bio
Melanie Bhatnagar is the Associate Director for Pediatric Education and Outreach within the Office of Pediatric Therapeutics (OPT) at the U.S. Food and Drug Administration. In her role overseeing OPT’s Pediatric Education and Outreach Program, Dr. Bhatnagar works to promote, enhance, and drive cross-cutting educational activities and initiatives to further knowledge on important issues pertaining to children’s health. She also works to build and strengthen strategic partnerships to drive and inform scientific and policy priorities to advance children’s health. Dr. Bhatnagar received her undergraduate degree from the University of Virginia and her medical doctorate from the George Washington University School of Medicine and Health Sciences. She completed her pediatric residency training at the University of Maryland and, prior to joining the FDA, spent several years in private clinical practice as a general pediatrician.
Instructions to Obtain Credit
(1) Launch the activity
(2) View the entire module online
(3) Complete the post-test
(must pass the post-test with a score of 80% to receive credit)
You may retake the post-test if you do not receive a passing score.
(4) Complete Evaluation and Print certificate
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the University of Arkansas for Medical Sciences. University of Arkansas for Medical Sciences 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.
Credit Designation Statements
AMA Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
ACPE Credit Designation Statement
These knowledge-based activities will provide pharmacists with up to 1 contact hour or 1 CEU. CE credit information, based on participation and completion of the program evaluation, will be provided to NABP within 60 days after the activity completion.
ANCC Credit Designation Statement
The University of Arkansas for Medical Sciences designates this enduring material activity for a maximum of 1 ANCC contact hours. Nursing contact hours will be awarded for successful completion of program components based upon documented attendance and completion of evaluation materials.
AAPA Credit Designation Statement
The University of Arkansas for Medical Sciences 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. This activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.
Disclosure Policy Statement
It is the policy of the University of Arkansas for Medical Sciences (UAMS), Office of Continuing Education (OCE) to ensure balance, independence, objectivity, and scientific rigor in all directly or jointly provided educational activities. All individuals who are in a position to control the content of the educational activity (course/activity directors, planning committee members, staff, teachers, or authors of CE) must disclose all relevant financial relationships they have with any commercial interest(s) as well as the nature of the relationship. The ACCME describes relevant financial relationships as those in any amount occurring within the past 24 months that create a conflict of interest. Individuals who refuse to disclose will be disqualified from participation in the development, management, presentation, or evaluation of the CE activity.
UAMS Office of Continuing Education (OCE) Contact Information
4301 W Markham Street #525
Little Rock, AR 72205
Email: cmeconf@uams.edu
Phone: 501-661-7962 Fax: 501-661-7968
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
You can download an official transcript from your CloudCME profile (https://uams.cloud-cme.com/default.aspx) or you can request a copy of your transcript at https://ce.uams.edu/transcript-request-2/.
