Key Issues

Clinical Trials

 

European Medicines Agency

International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines

Guidelines for good clinical practice E6(R2)

Guideline for good clinical practice E6 (R2)

Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials 

Guidelines on requirements pharma quality docs

ICH guideline E2F on development safety update report 

ICH guideline E2F on development safety update report

ICH Topic E3: Structure and Content of Clinical Study Reports

ICH Topic E3 – Structure and content of clinical study report ICH E3