News

Uppsala Reports

Keep up to date with the latest news on safer use of medicines, pharmacovigilance practice, the activities of the WHO Programme and related topics Read more

EMA to launch a new, improved EudraVigilance

EMA will launch a new and improved version of EudraVigilance on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions. The Agency is delivering training courses on the enhanced EudraVigilance system to support national competent authorities ... Read more

One Million Visits!

The Global Health Network would like to thank all of the researchers and groups who have made the effort to share their materials

The Global Health Network is celebrating a major milestone in it’s quest to enable life-saving evidence to be gathered in the world’s poorest countries. This is all about a digital platform for medical researchers around the world that is changing ... Read more

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

E-Learning

Articles

Cups or Cash for Girls (CCg) Trial in Western Kenya

by Global Pharmacovigilance

In clinical drug trials, researchers have an obligation to safeguard participants against harms which may be related to the interventional drug, and to ensure the benefit-to-harms ratio remains favourable for ...

Pharmacovigilance in pregnancy

by Global Pharmacovigilance

Pregnant women are largely excluded from clinical trials during drug development, unless the drug is specifically intended for use in pregnancy. Therefore often little is known about the risk of ...

DSMBs and clinical trial safety

by Global Pharmacovigilance

The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if contracted ...