Clinical Trials - Medical Device FDA's Program 2017

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. 

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.

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

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. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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