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

Inspections and Audits

Home » Topics » Clinical Trials » Inspections and Audits
  • June 14, 2018

    MHRA Cites Data Management and Integrity in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • June 4, 2018

    MHRA Cites Data Management, Integrity Issues in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • January 18, 2018

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

    France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials.
Read More
  • December 27, 2017

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

  • December 12, 2017

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

  • March 10, 2016

    Clinical Investigator Lands Warning Letter for Enrolling Pregnant Subject

  • December 14, 2015

    FDA Raises Alarm Over Unauthorized Clinical Trial

  • October 8, 2015

    Report Outlines Strategies for Risk-Based Monitoring

  • September 10, 2015

    Trial Investigator Warned Over Lack of SOP Documentation

  • June 11, 2015

    Device Trials Program Overhaul Aims for Speed, Consistency: FDA

  • June 11, 2015

    21st Century Cures Act Sails Through House Committee

  • May 7, 2015

    Expert Advises on Risk-Based Monitoring in Clinical Trials

  • May 7, 2015

    FDA Reduces Clinical Hold On Tekmira’s Ebola Drug

Read More

Products

  • International standards for clinical trials 500

    International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

    $249.00
  • Kara stockett quinn 500aqua

    The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript

    $287.00
  • Davidlchesney aqua500

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success – Webinar Recording/Transcript

    $287.00
  • Dennett kouri and faviola michelot 500blue

    Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript

    $287.00
More Products

Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

More
  • 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