Voisin Consulting Life Sciences glossary icon

Periodic Summary Reporting

Click a letter to view all its definitions

Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented. 

Other glossary definitions



An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described…

View definition

MA (Marketing Authorisation)

Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product,…

View definition