Meeting the Challenge of Device Studies
Speaker: Robert Romanchuk
Registration: Free and open for all to attend.
Program Description: Though investigational drugs and devices grew up side by side during the same era, they are by no means twin siblings, but rather fundamentally distinct. The regulations that shaped them grew out of different critical events and pressures. The result is a regulatory and operational landscape the must be well understood in order to mount successful device studies. This session will help attendees discern and anticipate these important differences with an eye to best practices in device studies and collaborative solutions for success. For attendees experienced in device studies, the session will highlight current trends and controversies in device studies.
Upon completion of this Webinar, attendees should be able to:
- Distinguish the unique historical and regulatory background of Medical Devices with a focus on current trends and challenges
- Recount the important differences between drug and device studies and their impact on the clinical trial process and individual stake‐holders
- Identify best practices to assure successful device studies and test them through interactive case studies
Target Audience: Clinical Research Coordinator, Clinical Research Nurse, Clinical Research Scientist, Director or Manager of Clinical Trial Operations, Director or Manager of Regulatory Affairs, Investigator, Monitor or Clinical Research Associate, Project Manager, Regulatory Specialist, Research Manager, Site Selection and Start Up, Trainer
Contact hours: 1 Contact hour has 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 registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non‐ Members
Level: Intermediate
Further Information: Speaker, Robert Romanchuk, is currently a Vice‐Chair at Schulman IRB and has 2 decades of experience in research operations and human subjects protections. His achievements include building and managing a central research operation for a large community health system, and numerous roles in the human subjects protections arena. He holds a BSHS in Clinical Research Administration from the George Washington University and CIP, CRCC, and CHRC credentials.