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 News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Device Products » Risk Management in Clinical Trials: The New ICH E6 Focus

Other Options

PDF Edition

$397.00

PDF Edition - 3-4 Copies (10% Off)

$357.00

PDF Edition - 5-6 Copies (15% Off)

$337.00

PDF Edition - 7-9 Copies (20% Off)

$317.00

PDF Edition - 10+ Copies (25% Off)

$297.00
Risk Management in Clinical Trials

Risk Management in Clinical Trials: The New ICH E6 Focus

$397.00
Device Products

Product Details

Revision 2 of ICH E6 emphasizes a risk-based approach to managing clinical trials, especially those that rely heavily on electronic data systems and software.

“As our clinical trials have continued to become more complicated with the increase in technology” — states Dr. Susan Leister, Director of Quality Assurance at Technical Resources International — “we strive to be more efficient. With this can come more risk.”

In Risk Management in Clinical Trials Dr. Leister explains the significance of the new focus on risk management and the benefits it can reap including:

  • Directing the sponsor’s limited resources to higher risk areas, resulting in better overall quality
  • Focusing more on prevention than on the traditional monitoring approach (process improvement vs. quality control)
  • Reducing potential regulatory inspection findings
  • Helping manage noncompliant sites/vendors/contractors
  • Allowing more coverage of critical areas in the same amount of time

She offers recommendations for implementing new requirements, including:

  • Implementing a quality management system that covers all stages of the trial process
  • Identifying critical processes and key data
  • Adopting principles of risk management — identification, evaluation, control, communication and review
  • Meeting centralized monitoring requirements
  • Validating electronic data processing systems
  • How to address noncompliance that has the potential to significantly affect human subject protection or reliability of trial results

Order your copy of Risk Management in Clinical Trials: The New ICH E6 Focus for expert instruction on how to adapt to new risk management requirements.

Who Will Benefit

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers
  • Compliance Staff
  • Clinical Quality Auditors
  • Quality Assurance Personnel

PDF

$397.00
Add to Cart

Author:
By Dr. Susan Leister

ISBN-13:
978-1-60430-056-7

Publication date:
February 2018

Page count:
201


Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.


Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

  • 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