Utilization of Real-World Evidence (RWE) and Real-World Data (RWD) and Regulations
Oct 24, 2022, 14:03 PM
Course ID :
295
Acronym :
CTLDMG
Navigate FDA regulations for real-world evidence and data with Barnett International. Take charge of your knowledge. Learn more!
The use of computers, mobile devices, wearables and biosensors to gather and store large amounts of health-related data has been rapidly accelerating. Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in healthcare decisions. In this web seminar, participants will gain insights into how this data holds potential to allow us to better design and conduct clinical trials and studies in the healthcare setting to answer questions previously considered infeasible. We will also examine FDA’s current practices for RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions.
- Develop a basic understanding of RWD and RWE
- Provide an overview of FDA regulations for RWD and RWE
- Become familiar with the framework for FDA’s Real-World Evidence Program
- Examine current FDA practices for RWD/RWE
- Gain insights into RWD/RWE utilization by healthcare professionals, medical product developers, clinical investigators, and regulators
- Healthcare Professionals
- Research and Development Specialists
- Directors of Business Strategy
- Project Managers
- Regulatory Professionals
- Clinical Investigators
- Data Managers
- Clinical Operations Specialists
Marina Malikova, PhD, MSci, MACI, RAC, CCRA
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biographies
$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
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#: 0778-0000-23-032-L99-P. Released: 3/23.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Series :
- Clinical Trials & Translational Medicine
Topics :
- Clinical Research
- Drug Safety & Development
- Medical Device
- Project Management
- Regulatory Compliance
Job Functions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Data Management
- Drug Safety
- Medical Affairs
- Project Manager
- Quality Control
- Regulatory Affairs
- Study Site Compliance
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