Site Challenges in Conducting Investigational Device Trials

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.

Areas Covered in the Seminar:

• Device and Drug Regulations; the differences.
• The risks peculiar to device studies.
• Budgets and contracts for device studies- how they differ.
• Contract and Budget hot spots.
• Executing device studies; the nuts and bolts.
• Managing pricing, charging and billing for investigational devices; how to stay out of trouble.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in the research enterprise, including:

• Sponsors
• Research Institutional Leaders
• Research Compliance professionals
• Clinical Research Professionals
• Billing/coding professionals

Event Details:

Date:              August 27, 2012

Time:              10:00 AM - 11:00 AM PDT

Cost:              $199 per attendee per computer terminal

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