Knowledge Management: ICH GCP E6 (R2) – Significance and impact of the adapted guidelines

Since the adoption of the first guideline of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on Good Clinical Practice (GCP) in 1996, clinical research has been constantly confronted with new challenges – e.g. globalization, increased trial complexity, improved technical resources. These challenges have now been taken into account in an amendment (R2) to the ICH GCP E6 guideline. To that end, the Vice President Clinical Operations at Impulse Dynamics GmbH, a Certified Physician Investigator (CPI), delivered a continuing education presentation entitled “How Does the Recent ICH GCP E6 Update Affect YOU? The Finalized ICH E6 (R2) GCP Guideline: What is New & Implementation Action Plan” for the employees of ClinTriCare GmbH & Co. KG as part of the ClinTriCare staff meeting on 21 and 22 September 2017. With more than 20 years of experience in clinical research and development, the speaker was an excellent presenter on this topic.

He explained to ClinTriCare staff the individual changes in the ICH GCP E6 (R2) update compared to the previous version in terms of their impact on ongoing clinical trials and how these changes affect the sponsor in monitoring its clinical trials. With this continuing education session, ClinTriCare staff were brought up to speed on the latest GCP guidelines and are now well-trained to make sure the new requirements are complied with.