| Event Name | Medical Device GCP and Monitoring |
| Event Date(s) |
Thursday, February 18, 2010
to
Friday, February 19, 2010
|
| Event Location |
Coral Springs Marriott
Coral Springs,
Florida
U.S.A.
|
| Cost | n/a |
| Description | This seminar was designed for those who desire an overview of the device approval process, the regulations that govern IDE studies, the CRA’s role in monitoring, and the FDA's role in auditing. It includes a review and discussion on recent monitoring and research site warning letters. It consists of a comprehensive review of the GCP obligations of the sponsor and the investigator, the regulations that protect the rights and safety of human subjects. A glance at the similarities and differences between the FDA regulations and the ICH GCP (E6) guideline, and a review of some key safety definitions from ISO 14155-1:2003. It also reviews the key documents and elements of the clinical investigation at the site level, including the Investigator Study File and the Sponsor's Trial Master file, as well as all the report requirements and the reporting timeframes. MRM provides each participant with a credit card size CD-ROM Regulatory Reference. |
| Sponsor | n/a |
| Host Company | n/a |
| Contact Information |
Phone:
877-633-3322
Fax:
n/a
Email:
n/a
|
| More Information |
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