Spring Intro 2023

03/03/2023

Clinical development

Non-clinical Safety Evaluation

Clinical Evaluation

Pivotal/Phase III Patients 1000's

PoC/Phase II Patients 100's

Phase I Healthy Volunteers 10's

Confirmatory Efficacy, Safety, Claims, Comparators, Health Economics

Preliminary Efficacy, Side Effects, Safety, Dose Selection/Regimen

Regulatory Filing

Safety ADME

1 yr

1 yr

2 yrs

3 yrs

11

CTD structure of the MA submission…

Module 1 – Administrative data + Regional information

1.0

TOC

Module 2: Summaries

2.2 Introduction

2.6 Summary 2.4 Overview

2.5 Overview

2.3 QOS

2.7 Summary

Modules 3,4,5: 3. Quality 4. Nonclinical 5. Clinical

4 Non clinical

3 Quality

5 Clinical

12

6