Adverse Event and Safety Reporting Policy 02-0001-P-V-1

49,00 $

Premade template for Adverse Event and Safety Reporting Policy in Word.

The form can easily be adapted to your particular company needs.

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