Clinical investigation of medicinal products in the pediatric population – Addendum to ICH E11

17 October 2017
clinical trial, drug development, extrapolation, formulation, ICH E11, modeling, pediatric formulation, pediatric population, simulation,

On 6 October 2017, the European Medicines Agency (EMA) published revised version of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population in the form of an addendum. This document will become effective on 28 February 2018. Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration

Revised guideline on first-in-human clinical trials (FIH CTs) (Part II)

30 July 2017
early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, risk mitigation,

On 25 July 2017, the European Medicines Agency (EMA) published revised version of Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This revised document will become effective on 1 February 2018. We have already informed on our website about a draft of the revised guideline

First-in-human Clinical Trials – FIH CTs (Part I)

12 April 2017
3Rs, early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, reduction, refinement, replacement, risk mitigation,

Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on