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ICH GCP Addendum E6 R2 comes into operation!

Today the ICH GCP Addendum E6 R2 comes into operation.
Therefore, we summarized the useful resources for your kind perusal:

  1. GCP E6 R2 Addendum itself – http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf
  2. PDF Mindmap of all GCP E6 R2 changes – https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/
  3. ICH GCP Goes Risk Based – a review article of the changes http://www.appliedclinicaltrialsonline.com/ich-gcp-goes-risk-based
  4. GCP Readiness Checklist from PPH plus – http://www.pph-plus.com/sites/pph-plus.com/files/pictures/2017-06-08_ich_gcp_readiness_questionnaire_-_3-fold_brochure.pdf
  5. Educational Webinar – GCP Gap Analysis with Andy Lawton – https://www.youtube.com/watch?v=sMBVLFf8g_U
  6. GCP GAP Analysis Template (PDF) – https://cyntegrity.com/cyntegrityedu-ich-gcp-gap-analysis-template/

Happy compliance!
Yours Cyntegrity

By | 2017-06-14T09:35:40+00:00 June 14, 2017|News|0 Comments

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.