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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

Useful links

Downloads

• Common Technical Document Brochure

Speakers

• Andrew Willis United Kingdom

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Venue

The Rembrandt Hotel

The Rembrandt Hotel, 11 Thurloe Place, London, SW7 2RS, United Kingdom

Useful links

Organised by

Contact information

Leigh White
Management Forum Ltd
10-12 Rivington Street,
London EC2A 3DU
+44 (0) 20 7749 4730
Contact us by email

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