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CE Credits Available for this Activity: 1
Program Overview: The purpose of this activity is to educate medical professionals on reporting adverse events and FDA inspections.
Target Audience: The target audience includes all healthcare professionals such as physicians, nurses, pharmacists, and allied health professionals who would like to learn how to document and report adverse events, explain what do during an FDA audit, and identify ways to effectively communicate with the FDA and IRB.
Release and Expiration Dates
04/23/2024 – 04/23/2027
Objectives
Define, document and report Adverse Events.
Prepare for, navigate and respond to an FDA audit.
Demonstrate effectively how to communicate with FDA and IRB.
References
US Food & Drug Administration (FDA)
US Department of Health & Human Services
National Institute of Health (NIH)
Faculty Disclosure
The following planners, speakers, moderators, peer reviewers, and/or panelists of this CE activity have financial relationships with ineligible companies to disclose:
Jessica Snowden, MD – Consultant: Pfizer
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: Jessica Snowden, MD; Jeannette Lee, PhD; Lora Lawrence, RN; Catrice Banks-Johnson, MPA; DeAnn Hubberd, MA
Speaker(s): Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS
Speaker(s) Bio
Laura’s career in the field of research has been marked by a strong focus on regulatory affairs and ensuring the safety and integrity of research data. With a master’s degree in psychology, specifically in Industrial/Organizational Psychology, Laura began her career at the University of Arkansas for Medical Sciences (UAMS), where she spent 14 years as a data and regulatory coordinator. Her work involved monitoring regulatory compliance, data coordination, and other important research-related activities.
Her experience led her to transition into a role focused on monitoring, and she is currently serving as the Director of the Office of Research Regulatory Affairs (ORRA) at UAMS. In this role, she oversees regulatory affairs and acts on behalf of UAMS as a sponsor for FDA-regulated research involving Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). This position requires her to stay current with the constantly evolving regulations and requirements in the field of research.
Throughout her over 20-year career, Laura has emphasized the importance of continuous learning due to the dynamic nature of research regulations. She is dedicated to supporting researchers and their teams, providing guidance and education to help them navigate the complexities of research requirements. Her personal goal is to contribute to the local community by advancing research, offering support for all study-related activities, and ensuring the safety of research subjects and the integrity of data.
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 1.0 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/.
