ICH Guideline on the Common Technical Document revised

The ICH M4(R4) Guideline reaches Step 4 of the ICH process and now enters the implementation period (step 5)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) unites regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of the drug registration process. Click here to read more about ICH. Read more



My pharmacovigilance PhD journey

by Paul Cross

How the topic was conceived I started working in clinical research in the UK in 2004, directly after finishing my BSc in Applied Biology. After several years of work I ...

Drug Safety Glossary

by Global Pharmacovigilance

A Drug Safety Glossary has been developed to help overcome some of the difficulties in understanding and using the various terms and phrases used in pharmacovigilance. Many of the terms ...