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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

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Cochrane Crowd

by The Editorial Team

Cochrane Crowd, Cochrane’s new citizen science platform, is a global community of volunteers who are helping to classify the research needed to support informed decision-making about healthcare. The job ...

AERSMine - an adverse event data mining tool

by Global Pharmacovigilance

A novel application utilising data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been developed by a Biomedical Informatics team at the Cincinnati Children ...