Spring Intro 2023

Jenny Lamport

Nonclinical overview

 ‘In general’ not more than 30 pages

 Function: ● To provide an INTEGRATED and CRITICAL assessment: – Pharmacology – Pharmacokinetics – Toxicology

 Nonclinical summary is factual

The Organisation for Professionals in Regulatory Affairs

27

Clinical overview

 ‘About’ 30 pages

 Function: ● To provide a critical analysis of the clinical data – Present the conclusions and implications ... not recapitulate them – Clinical summary is factual

The Organisation for Professionals in Regulatory Affairs

28

14