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Site language : English - Français
Ref : 25598
Event :Clinical Trials - Medical Device FDA's Program 2017

Date :Thursday August 24th, 2017

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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
 
Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501420LIVE?channel=doctorama_Aug_2017_SEO

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Presentation sheet from Compliance4All

Details

Clinical Trials - Medical Device FDA's Program 2017 Medicine - Management - Public Health
clinical trails program, medical device, fda webinars, medical device complaint handling training, medical specialist programs, training courses on medical devices, medical devices sales training, 2017 medical webinars
Professionals, R&D and Regulatory Staff Management of R&D Regulatory
100 1 --
English

Other

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