Upcoming Events

There are no upcoming events at this time.

Register Today!

Get Free Test Access

ICH GCP Addendum E6 R2 comes into operation!

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.