Understanding and Incorporating ICH E6(R2)

In November 2016, ICH published an addendum to its guidelines for clinical practice, prompting pharmaceutical companies to align current clinical quality procedures with a risk-based monitoring approach. What was previously a general recommendation by ICH to have a robust quality management program for clinical trials is now a more specific and focused recommendation to ensure clinical quality and data integrity. The updated ICH guideline along with FDA’s continued scrutiny of clinical research operations has brought clinical quality assurance back to the center of importance and discussion throughout the pharmaceutical industry.

The goal of the updated ICH E6 R2 guideline is to push pharmaceutical companies to have a more holistic approach to the clinical quality management system, with quality by design principles and risk-based monitoring serving as the foundation for the addendum. Many clinical quality teams have placed a major focus on the implementation of risk-based monitoring; however, the ICH addendum addresses much more than RBM practices, and it is vital that pharmaceutical companies adapt the entire quality management system in order to truly be aligned with the revised guideline.

To see the specific amendment that correlates to the main areas of clinical research listed below, download Q1 Production’s 7 page Comprehensive PDF.

  • GLOSSARY
  • THE PRINCIPLES OF ICH GCP
  • INVESTIGATOR
  • SPONSOR
  • CONTRACT RESEARCH ORGANIZATION (CRO)
  • TRIAL MANAGEMENT, DATA HANDLING, AND RECORD KEEPING
  • MONITORING
  • NONCOMPLIANCE
  • ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

Q1 Productions’ Clinical Quality Compliance and Risk Management Conference will bring together clinical quality executives from a variety of pharmaceutical companies to share valuable insights on the implementation of risk-based monitoring while also addressing innovative approaches for tackling ongoing challenges in clinical quality.

The entire ICH Harmonized Guidelines Document  can be found here: https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf

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