Common Technical Dossier

14 December 2016 09:00 - 15 December 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
Contact information
Showing all upcoming events
Start Date
End Date
Subject area
Event type


E-mail Enquiry