Common Technical Dossier

5 July 2017 09:00 - 6 July 2017 17:00, London, United Kingdom


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
Speakers
Venue
The Rembrandt Hotel

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

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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