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