ICH E19 public consultation

A new ICH-E19 draft guideline on the optimisation of safety data collection in interventional clinical trials and non-interventional studies has been published by ICH for public consultation. The guideline objective is to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such approach would be implemented. Comments should be submitted by 29 September 2019 to the following email address: ichema [dot] europa [dot] eu (ich[at]ema[dot]europa[dot]eu).

Related information:

» ICH E19 public consultation version 

» EMA public consultations