The Challenges of Conducting Investigational Device Exemption Studies: 21 CFR 812 Requirements
Friday, August 2, 2013 from 10:00 AM to 11:00 AM (PDT)
This webinar will highlight the regulatory differences between IDE and IND studies and identify risk areas that are specific to IDE studies. It will discuss operational challenges in conducting IDE studies and show you how to charge and bill for IDEs.
Why Should You Attend:
Investigational Devices are unique both in the regulatory structure governing their use and in the practical execution of clinical trials. Confusing them with Investigational New Drugs (INDs) can lead to difficulty both in compliance and the successful trial execution. All parties involved in IDE studies, including Sites, Sponsors, CROs and IRBs do well to understand the distinctions and understand how to accommodate the differences in their part of the process.
This session will highlight the differences between IDE and IND studies - study design, regulatory oversight and approval, IRB oversight, device accountability, payors and billing, data collection and reporting, patient safety and more. The presenter will help you gain a clear understanding of the specific points of divergence from the more familiar IND pathway to ensure you avoid risk and maximize the likelihood of successful trials.
At the end of this session, attendees will be able to:
- Recount the basic regulatory differences between IDE and IND studies
- Identify risk areas specific to IDE studies
- Accommodate IDE considerations in the contract and budget negotiation process
- Anticipate and accommodate operational challenges specific to IDE studies.
- Create processes that assure institutional compliance in billing for IDEs
Areas Covered in the Webinar:
- How regulatory mechanisms governing IDEs developed uniquely from INDs
- Points of divergence in IND and IDE regulations.
- The IRB oversight of IDE studies.
- Operational challenges in conducting IDE studies.
- Contract and budget considerations in IDE studies
- Charging and billing for IDEs
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