ACRP 2019 Conference Session Replay: Early feasibility study (EFS) is the new outside the United States (OUS) strategy for early-phased medical device clinical trials
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- Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Conformal Medical, Inc.
- Victor Chen, Director, Clinical Affairs, Align Technology
- Maureen Dreher, Ph.D, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health
- Project Managers
- Regulatory Affairs/Compliance
- Quality Assurance
- Clinical Research Administrators
This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.
11:30 am –12:00 –Networking Opportunity-Lunch Provided
12:00 – 1:00 pm – Educational Presentation Learning Objectives
- Define FDA's Early Feasibility Study (EFS) Program.
- Outline the risks/benefits of participating in the EFS program for early-phased clinical trials.
- Outline strategies to leverage EFS protocols for PMA and 510 submissions.
Contact hours: 1.0 Contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Registration Cost: FREE to all Chapter Members, ACRP Members, Non-Members
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not applicable