A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
FDA’s Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice
Upcoming Courses
Course Description
The FDA is exploring the integration of randomized controlled drug trials (RCTs) into routine clinical practice. These “point of care trials” aim to streamline protocols, focusing on essential data collection. This approach could improve accessibility and diversity in enrollment. This web seminar will review the FDA’s initiative on bridging the gap between clinical research and everyday patient care.
Learning Objectives
- Discuss Sponsors’ role in engaging healthcare institutions
- Assess Clinical Investigators’ and local healthcare providers’ roles
- Examine processes for aligning trials with clinical practice
- Review quality by design elements in clinical trials
- Explain guidance on informed consent, data privacy, and ethics
- Describe leveraging real-world data sources in trial conduct
Who Should Attend
- Clinical Research Coordinators and Managers
- Principal Investigators and Sub-Investigators
- Regulatory Affairs Professionals
- Quality Assurance Specialists
- Clinical Trial Sponsors
- IRB/Ethics Committee Members
- Medical Affairs Professionals
- Clinical Operations Team Members
Instructor
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
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#: 0778-0000-25-026-L99-P. Released: 2/25.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
