Clinical Trials - Medical Device FDA's Program 2017

Website http://www.compliance4all.com/control/w_product/~product_id=501420LIVE?channel=ourglocal_Aug_2017_SE | Edit Freely

Category 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, medical device software training

Deadline: August 23, 2017 | Date: August 24, 2017

Venue/Country: Online, U.S.A

Updated: 2017-06-15 15:20:21 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com