Module 5 Presentations

19/07/2024

Case Study 3 (2)

• Abdullahi v. Pfizer Inc • Nigerian government called the trial "an illegal trial of an unregistered drug” • Alleged that participants and their families were not told that they were part of a trial • Survivors brought claims in US • Despite three judicial opinions dismissing claims on procedural grounds, ultimately substantial settlement payment was made by Pfizer

The Organisation for Professionals in Regulatory Affairs

41

Clinical Study Contracts

• Record of agreement

– Essential elements

- offer and acceptance - consideration - intention to create legal relations

– Form

- written rather than oral - implied terms - templates

The Organisation for Professionals in Regulatory Affairs

42

21