CRED Project Management for Regulatory Affairs Professionals

Transferring the Knowledge – Real life example

 Project Review [PROCESS]: Regulatory Strategy and Delivery on a Phase III Global Clinical Development for Alzheimer's Disease Programme. [Study included use of tracers]  Challenges – What did not go well [Development] ● Clinical Trial Applications – Received More than 50% Validation Queries ● Every Clinical Trial Application received Regulatory Questions: – Questions on IMPD, Protocol Design, Application Forms. ● Resulted in more than 50% Country-Specific Protocol Amendment’ – Impact: Study Result Analysis, as this was intended to be the pivotal study for Marketing Authorisation Application.