Boston Professional Events List


Clinical Trials - Medical Device FDAs Program 2017


Date
Aug 24, 2017 - 10:00 AM
Organizer
Coompliance4All
Venue
Online Event
Location
161, Mission Falls Ln

Fremont,
CA,
USA,
ZIP: 94539
Phone: 18004479407

Ticket Price: One Dial-in One Attendee Price: $150.00
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]

Event Categories
Keywords: Clinical , Educational, FDA, medica




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