Clinical Trials - Medical Device FDA's Program 2017
This Webinar is over| Date | Aug 24, 2017 |
| Time | 10:00 AM |
| Cost | 150.00 |
|
Online
|
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: support@compliance4All.com
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: support@compliance4All.com
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