Site Challenges in Conducting Investigational Device Trials - Webinar By ComplianceOnline (Clinical Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Aug 27, 2012 End Date/Time: Aug 27, 2012
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Description

This webinar will review the principal differences in regulations governing investigational device (IDE) studies and drug (IND) studies and help you understand where the regulations diverge and how this impacts the design and execution of device studies.

Why Should You Attend:

Both sponsors who undertake clinical trials with investigational devices and the institutions that host them take on obligations and risks that are unlike those related to investigational drug studies. To proceed without an in depth knowledge of these matters can expose institutions, investigators and sponsors to risks that can easily be managed with a good understanding of the issues.

The regulations governing Investigational Device (IDE) studies are distinct in many respects from those governing investigational drug (IND) studies. Likewise, the processes created to carry them out are distinct and require and a good understanding of those differences is essential to compliant and successful studies.

This session will offer an overview of where the regulations diverge and how this impacts the design and execution of device studies. Additional issues related to device studies, such as Medicare approval and reimbursement, billing and coding and other areas of risk will be discussed. This course is recommended for both those experienced in device studies and those just now entering the field.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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