Clinical Trials 2016 - Conference topic on FDA's Medical Device Clinical Trials Program by Compliance4all

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
Speaker Profile:
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/2aWhBD3
Twitter Follow us ? https://twitter.com/compliance4all
Facebook Like us ? https://www.facebook.com/Compliance4all
Pinterest - https://in.pinterest.com/compliance4all/