Document Description
The Adverse Event and Safety Reporting Policy should be in place for all companies with commercial products on the market. It inform all company staff, contractors and partners that they are personally responsible for reporting any safety events they become aware of to the drug safety function in the company within 1 day. It is a requirement for all ICH regions (US,EU and Japan + UK) and it is always a subject for inspections so it is important to have in place and have documentation that all staff++ is trained on this policy annually
It comes in word format and is easy to adapt for your company use
