CRED NPM

06/11/2024

Case Study 1 – Sildenafil Switch

Dr Kate Stockman

Vice President Regulatory Affairs EMEA Kenvue

(Ex Global Rx to OTC Switch Lead @ Pfizer Consumer Health)

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Contents

Part A – Centralised Switch

•

• Background to the initial Viagra switch application

• ED definition and treatment

• Issues raised in 2008

• Part B – Decentralised Switch

• Key Hurdles to overcome

• Development of alternative switch model

• Key Learnings

The Organisation for Professionals in Regulatory Affairs

2

1