Compliance4All, Online Event
2016-10-11
Overview: The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
Why should you Attend: In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial. The probability of a successful trial is a function of the thought and experience that goes into a trial design. The thought, organization, compliance and analysis can be assisted by outside consultancies, such as CROs, but the experience has to be internal, a deep knowledge of the particular device, how it works, what its limitations are, what the company wants it to do, and the likelihood of its performing as desired.
Areas Covered in the Session: Introduction Valid scientific evidence Phases of device human studies Significant/non-significant risk IDE meaning, content, review Exemption from IDE rules Labeling/charging for product QSR design control integration Expanded access Post marketing studies
Who Will Benefit: R&D and Regulatory Staff Management of R&D Regulatory
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