The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: August 24, 2017 from 10am to 11am
Street: 161 Mission Falls Lane, Suite 216
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Jun 22
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:
Valid Scientific Evidence
Phases of Device Human Studies
IDE Meaning, Content, Review
Exemption from IDE rules
Who Will Benefit:
R&D and Regulatory Staff
Management of R&D Regulatory
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.
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