Module 17 2024

27/11/2024

The Role of the RA Professional and Good Regulatory Practice

Submission phase:

• Peer review

• Identify remaining gaps and weaknesses

• Check availability of key team members

• What was approved?

• Archive submission information

The Organisation for Professionals in Regulatory Affairs

Lecture 1

17

The Role of the RA Professional and Good Regulatory Practice

Post approval phase:

• Ensure specific approval commitments are met

• Stay involved /keep asking questions

• Plan in time for renewals and for ongoing processes

• Keep up to date with requirements

The Organisation for Professionals in Regulatory Affairs

Lecture 1

18

9