Module 17 2024

27/11/2024

The Role of the RA Professional and Good Regulatory Practice

Blue sky /concept stage:

• Get involved/Ask questions:

• What does it do? how does it do it? what’s it made of? who is it for? • Which markets are of interest? • Communication • regulatory strategy • risk • Planning • Timelines (internal and external) • Costs e.g. Notified Body fees

The Organisation for Professionals in Regulatory Affairs

Lecture 1

15

The Role of the RA Professional and Good Regulatory Practice

Design and development phase:

• Stay involved /keep asking questions • Changes to the device….or the claims • Have timelines slipped? • Communication • Flag any gaps • Have regulatory requirements changed?

The Organisation for Professionals in Regulatory Affairs

Lecture 1

16

8