U.S. Food & Drug Administration

Description

This enduring material focuses on the expanding role of artificial intelligence (AI) in clinical research. The presenters will discuss how technology such as AI and digital health technologies are being used to transform and advance drug development, as well as touch on the actions FDA is taking to help industry overcome challenges associated with the implementation of AI.

References

Artificial Intelligence and Machine Learning (AI/ML) for Drug Development: https://www.fda.gov/science-research/science-and-research-special-topics/artificial-intelligence-and-machine-learning-aiml-drug-development
Digital Health Technologies (DHTs) for Drug Development: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development
The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies: https://www.fda.gov/drugs/news-events-human-drugs/evolving-role-decentralized-clinical-trials-and-digital-health-technologies
Real-World Evidence: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products – Discussion Paper and Request for Feedback: https://www.fda.gov/media/167973/download?attachment
FDA Clinical Investigator Training Course (CITC) 2022: https://www.fda.gov/drugs/news-events-human-drugs/fda-clinical-investigator-training-course-citc-2022-12072022

Learning Objectives

Explain how decentralized clinical trials and digital health technologies may be used in clinical trials and drug development.
Discuss the rising use of artificial intelligence in clinical research and drug development.
Identify potential challenges associated with the use of AI and how FDA is working to address those challenges.

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

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.

This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 0.50 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 JA0002895-0000-24-076-H01-P, and ACPE Universal Activity Number JA0002895-0000-24-076-H01-T for 0.50 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 0.50 contact hour(s).

AAPA

FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.50 AAPA Category 1 CME credits. Approval is valid until June 9, 2027. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 0.50 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

ElZarrad, Khair, PhD, MPH, Director - Office of Medical Policy, U.S. Food and Drug Administration - nothing to disclose
Roach, Sara, PharmD, Pharmacist, FDA - I have the following relationship(s): Walgreens Pharmacy - Employee

Planning Committee

Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
June 10, 2024

Expiration Date
June 9, 2027

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