White Paper

ICH GCP E6 (R2): A Primer For Small Biotech And Specialty Pharma Companies

Enhanced Assurance Of Quality Supply For Single-Use Pre-designed Solutions

Recent updates to the ICH Good Clinical Practice guidelines call for implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to ensure human subject protection and data integrity. Now, biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) was first produced in June 1996 as an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. While the original ICH GCP still provides an excellent standard for the conduct of clinical trials in humans, the research environment has changed since those guidelines came into effect.

In 2016, ICH GCP – which remained unchanged for 20 years – was updated by means of an addendum, which provides additional guidance without changing the existing text. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.

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