Common Technical Dossier

14 June 2016 09:00 - 15 June 2016 17:00, London, United Kingdom

This course will cover the following topics:
  • Development, analytical, formulation and quality experts to contribute to the effective compilation of CTD and allow effective review of documentation requiring agreement by regulators
  • Drive full understanding of Quality by Design, Critical Attributes and developing new product using the CQA Pyramid model
  • Compile and submit Module 3 (CTD) of your registration dossier
  • Identify development needs for applications taking a “right first time” development approach and utilizing QBD
  • Identify extent of content expected by EU and US regulators
  • Provide practical experience and examples
  • Achieve the quickest turnaround of your submission
  • Deal effectively with your internal and external clients
  • Manage the Pharmaceutical Development and Quality aspects of your developments and registration dossier in Europe and US
  • Ensure all data needed has been collected in efficient manner
  • Ensure Right First Time development
  • Meet the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
  • Incorporate Quality By Design into your developments
The Rembrandt Hotel

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

Organised by
Management Forum Ltd
10-12 Rivington Street
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