Spring Intro 2023

16/02/2023

Open uncontrolled design

Test drug

• Not useful for collecting robust efficacy data • Highly efficient (and very common) for collection of safety data • Often used to expand patient safety database to meet ICH E1A requirements and/or expectations of regulatory authorities

The Organisation for Professionals in Regulatory Affairs

23

Role of the regulatory professional

The Organisation for Professionals in Regulatory Affairs

24