FDA's Draft Guidance on Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Course Description

Historically, information regarding therapeutic interventions for children has been extrapolated from clinical research conducted on adults; however, there are circumstances under which use of this data is less than ideal. Although children represent over one quarter of the world’s population, fewer than twenty percent of the applicable studies registered on clinicaltrials.gov are focused on understanding the medical needs of children. This web seminar will focus on the FDA’s new draft guidance for the safe and controlled inclusion of children in clinical trials where their unique needs are the primary consideration.

Learning Objectives

• Review the ethical framework for inclusion of children in clinical trials
• Determine pediatric risk categories and potential interventions
• Assess risk associated with clinical trials in a vulnerable population
• Examine clinical trial design interventions to mitigate risk

Who Should Attend

• Directors of Clinical Operations
• Clinical Principal Investigators
• Clinical Research Coordinators
• Clinical Research Associates
• Project Managers
• Professionals from Academia whose institutions conduct research in the pediatric population
• Clinical Quality and Compliance Professionals
• Institutional Review Board Administrators and Members
• Medical Monitors and Safety Team Members
• Regulatory Affairs Professionals

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Registration Fees

$835

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-033-L99-P. Released: 1/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.