Utilization of Real-World Evidence (RWE) and Real-World Data (RWD) and Regulations

Course DescriptionThe 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. Learning Objectives 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 Who Should Attend Healthcare Professionals Research and Development Specialists Directors of Business Strategy Project Managers Regulatory Professionals Clinical Investigators Data Managers Clinical Operations Specialists InstructorMarina Malikova, PhD, MSci, MACI, RAC, CCRAClick here for complete trainer biographiesRegistration Fees$835**Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.Accreditation InformationBarnett 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.