Module 6

04/10/2024

Risk Management – Develop a Communications Toolkit

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

33

Issue Management & Regulatory Affairs

• RA is one of the interfaces between Internal and External processes (PR, agencies)

• Work with Quality & Pharmacovigilance – regular formal meetings – take minutes!

• RA must always be involved in Product Related Issues

• The Legal Responsibilities associated with MAAs, CTAs and other Authorisations must always be taken into account

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

34

17