Common Technical Dossier

Introduction

This course will cover the following topics:

Effective compilation of CTD and critical review of documentation
Quality by design, critical attributes and developing new product using the CQA pyramid model
Compiling and submitting Module 3 (CTD) of your registration dossier
Identifying the extent of content expected by EU and US regulators
Achieving the quickest turnaround of your submission
Managing the pharmaceutical development and quality aspects of your developments and registration dossier in Europe and US
Ensuring right first time development
Meeting the legal framework and guidelines for the CMC / quality part of the dossier, and links to GMP