We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Device Products » Observational Research - Webinar CD/Transcript

Other Options

Audio CD/Transcript - Sept. 6, 2017

$287.00

Audio CD/Transcript - Sept. 6, 2017

$258.00

Audio CD/Transcript - Sept. 6, 2017

$244.00

Audio CD/Transcript - Sept. 6, 2017

$230.00

Audio CD/Transcript - Sept. 6, 2017

$215.00

Observational Research - Webinar CD/Transcript

$287.00
Device Products

Product Details

Observational Research: Gathering Evidence in the 21st Century

The 21st Century Cures Act promises to usher in a new era of drug development by dramatically lowering the cost of clinical trials while speeding the path to market.

The Act lets drugmakers substitute observational data and “in house” registry data in place of new, randomized clinical trial data. But much remains unclear. Would you be confident defining:

  • What exactly constitutes ‘significant evidence’?
  • What level of statistical strength are regulators looking for?
  • When is a data point merely an anecdote?

To take full advantage of the Cures Act, you need answers now. And FDAnews is providing them.

Noted researcher Jeff Trotter shows you how to take full advantage of the Cures Act and start reducing drug trial costs today. In a mere 90 minutes, Mr. Trotter brings you up to speed on:

  • The FDA’s fast-evolving views on the health-improvement and the cost-saving potential of observational studies and patient registries
  • Case studies of patient registries and observational studies — the well-designed vs. the poorly designed
  • Tips for using effectiveness, safety, HRQoL, satisfaction and resource utilization data to make your case to regulators and payers
  • Best practices for building study teams capable of managing comparative effectiveness research (CER) and health economics and outcomes research (HEOR)
  • And much more!

Join the 21st Century! Start taking full advantage of the Cures Act and reap dramatic benefits — lower costs for clinical trials, speedier drug approvals, greater profits. Order now.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing