Module 17 2024

03/12/2024

ASA ruling Omega Pharma Ltd – 19 October 2022

• High level of substantiation required

• 10 papers provided, including 4 RCTs

• Supported the underpinning concept ✓

• But RCTs flawed – 2 on nasal surgery patients, 1 not blinded, 1 on patients with cold symptoms (so could not study prevention of cold symptoms) 

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

15

Medical device specific advertising regulation

The Organisation for Professionals in Regulatory Affairs

TOPRA MSc Module 17

16

8