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

Deadlines

Useful links

Downloads

Brochure Download for Common Technical Document

Speakers

Andrew Willis Independent Consultant in Advanced Regulatory Affairs , United Kingdom

Venue

The Rembrandt Hotel

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

Useful links

Organised by

For over 30 years Management Forum has been an internationally renowned independent training company which organises professional conferences, seminars and in-house courses for the Life Science and Intellectual Property sectors. Our aim is to provide you with the highest quality events, that update you with the very latest information and are relevant and important to both you and your company.

We pride ourselves on our links to the best and most knowledgeable expert speakers in your business sector. We believe in bringing you together with your peers in order to learn, engage, share and network with the very best. We hold events in major cities throughout Europe including London, Barcelona, Nice, Amsterdam, Copenhagen and Prague and have welcomed participants from 80 countries to our events for over 30 years.

We are Experts in knowing the Experts you will want to hear from and have been bringing you this Expertise since 1983.

Contact information

欧美AV

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