EN 日本語 Search Investors Investigators Contact Us Services Therapeutics Innovation Insights News & Events About Careers Latest News Articles & Whitepapers Home › ICON Insights › ICH GCP guidelines ICH GCP guidelines Connect with us Contact us form Submit request for proposal Update email preferences Global office locator ICON on social media Social Sharing New ICH GCP Guidelines released On 30 November 2016, the International Conference on Harmonization of Good Clinical Practice, issued amended guidelines. Now is the time to familiarise yourself with the main components of the guidelines, gain an understanding of the new risk management paradigm and the framework that facilitates easier adoption of innovative technologies. Patient Centric Monitoring ICON's risk based, patient focused methodology for the design and execution of an adaptive monitoring strategy already has a quality management system, risk management system and innovative proprietary technology to support implementation of these new guidelines. What are the changes? The addendum focuses on three key areas; technology validation and certification, risk based quality management systems and increased oversight as illustrated below. Contact us today to find out more about ICON's readiness and how we can support you to align with new ICH GCP Guidelines. 2016 ICH GCP (R2) summary (excluding 5.18RBM) Technology System validation and continuity System access and data integrity Certified copies (Risk based) Quality Management Plan for Risk Control or tolerate Risk and Error Address Significant Non-compliance Communicate and Adapt Plan Oversight Investigator/Institution oversight Sponsor oversight Essential Document Control CONTACT ABOUT ICON RESULTS & REPORTS for Clients Therapeutics Services Insights Innovation ICON for Investigators Media Volunteers Investors Jobs & Careers News & Events Press Releases Events ICON on Social Media © 2017 ICON plc. Sitemap Disclaimer Privacy LinkedIn Twitter Facebook Youtube

EN 日本語 Search Investors Investigators Contact Us Services Therapeutics Innovation Insights News & Events About Careers Home » News & Events » Social Media Social Media CONTACT ABOUT ICON RESULTS & REPORTS for Clients Therapeutics Services Insights Innovation ICON for Investigators Media Volunteers Investors Jobs & Careers News & Events Press Releases Events ICON on Social Media © 2017 ICON plc. Sitemap Disclaimer Privacy LinkedIn Twitter Facebook Youtube