Common Technical Dossier

4 December 2018 09:00 - 5 December 2018 17:00, London, United Kingdom


Introduction
This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for global roll out of the document to ROW regions including, LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMCapplications after two days of intensive lectures, group work, and discussion session, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.

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 document, and links to GMP
WHY YOU SHOULD ATTEND

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMCaspects of applications after two days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.

WHO SHOULD ATTEND
  • Senior Analytical Chemists
  • Formulation Chemists
  • Technical Services Chemists
  • Registration staff (all levels)
  • Quality Managers
  • Quality Control Directors
  • R & D Project Managers
Speakers
Venue
The Rembrandt Hotel

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

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.
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