Module 6

04/10/2024

Other Sources of Information

SmPC is the key reference document provided by the MAH but other sources include

● Clinical guidelines

● Formularies

● Medical journals

● Medical conferences

● Company representatives

● Promotional and non-promotional materials

● Internet (including regulatory agency websites, public assessment reports)

The Organisation for Professionals in Regulatory Affairs

17

HCP survey of document usage

Source: Presentation from HCP Working Party, March 2016 Responses from >500 HCP participants via organisations in contact with EMA

The Organisation for Professionals in Regulatory Affairs

18

9