Clinical Trials - Medical Device FDA's Program 2017

  • Check with publisher
  • Published date: June 14, 2017
    • Fremont, California, United States

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=marketplace_Aug_2017_SEO

Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Evaluation of Expression System

    Evaluation of Expression System

    Biomedical Sciences Shirley (New York) November 30, 2018 Check with publisher

    Vaccine production has several stages. The first step is to generate the antigen itself that will trigger the immune response. The viruses are grown on primary cells such as chicken eggs, or on continuous cell lines such as cultured human cells while...

  • Dihydrotestosterone [KLH]

    Dihydrotestosterone [KLH]

    Biomedical Sciences Shirley (New York) October 23, 2018 Check with publisher

    Dihydrotestosterone is a biologically active metabolite of the hormone testosterone, formed primarily in the prostate gland, testes, hair follicles, and adrenal glands by the enzyme 5a-reductase by means of reducing the 4,5 double-bond. https://www.c...

  • α-Gal ELISA Kit

    α-Gal ELISA Kit

    Biomedical Sciences Shirley (New York ) June 28, 2018 Check with publisher

    Mouse α-Galactosyl ELISA Kit kit is a 1.5 hour solid-phase ELISA designed for the quantitative determination of the α-Galactosyl. This ELISA kit is for research use only, not for therapeutic or diagnostic applications.