Clinical Trials with Medical Devices Program
Full program description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
Demonstrating the safety and effectiveness of new medical devices is a critical part of the medical product development process and requires significant resources to accomplish. This symposium provides perspectives from physicians and medical device experts to discuss the complex regulatory process of various medical device classifications, U.S. and international requirements, trial management, and pediatric needs within the framework of Good Clinical Practices.
This symposium is comprised of 7 sessions providing an overview of medical devices and their essential clinical trial requirements.Participants earn contact hours for each session and at the completion of all 7 sessions earn a badge recognizing completion of the symposium.
At the end of this symposium, participants will understand the various types of medical device classification and regulatory requirements, and gain knowledge of coordinating, monitoring, and managing a medical device clinical trial.
- Session 1: History, Terms/Definitions and Regulatory Requirements
- Session 2: IRB Reviews on Medical Device Trials
- Session 3: Quality at the Data Level
- Session 4: Medical Device Feasibility Clinical Trials – A Medical Case Study
- Session 5: Advanced International Trials with Medical Devices
- Session 6: Auditing of Medical Device Trials
- Session 7: Gaps and Opportunities in Pediatric Device Trials
Learner Level: Beginner
This symposium is for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.
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