This course aims to give you knowledge of pre-marketing pharmacovigilance legislation in the European Union.

This course firstly deals with the EU Regulatory framework governing drug safety during clinical trials (briefly mention FDA):

• Definitions, Adverse Reaction Reporting (ICH E2A)
• Overview of Good Clinical Practice

Then, provides a brief overview of relevant FDA regulations

 And finally, describes Safety Update Reports (ICH E2F)

At the end of this course, you will be able to understand the legal framework that governs the pre-authorisation phase including efficacy aspects Clinical Trial Assay authorisation, Investigational New Drug, approval for studies & Good Clinical Practice.