ICH GCP Goes Risk-Based
by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Originally published by Applied Clinical Trials Online Available: http://www.appliedclinicaltrialsonline.com/ich-gcp-goes-risk-based.
Oct
2015
Sep
2015
ICH GCP Addendum Mind Map
The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP. Let [...]
May
2015
ICH Goes Risk-Based
ICH GCP Goes Risk-Based GCP Addendum Review and Embracement Plan by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Web-View AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes [...]