The Common Technical Document

  • 02-03 Jul 2024
  • 25-26 Nov 2024
  • Online Event


The Common Technical Document is a course dedicated to the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

The Common Technical Document covers topics such as:

  • Quality by design (QbD), critical attributes and developing new product
  • Effective compilation of the Common Technical Document (CTD) and critical review of documentation using the CQA pyramid model
  • Identifying the extent of content expected by EU and US regulators
  • Compiling and submitting Module 3 (CTD) of your registration dossier
  • Managing the pharmaceutical and quality aspects of your developments and registration dossier in Europe and the US
  • Achieving the quickest turnaround of your submission
  • Meeting the legal framework and guidelines for the CMC/quality part of the dossier and links to GMP
  • Ensuring right-first-time development

The Common Technical Document brings together:

  • Formulation chemists
  • Senior analytical chemists
  • Registration staff (all levels)
  • Technical services chemists
  • Quality control directors
  • Quality managers
  • R&D project managers

The next Common Technical Document will be held on 02-03 Jul 2024.

More Details

1099-1299 Pound Sterling (Estimated)
Management Forum

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Please, check "The Common Technical Document" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Industry: Chemicals
Science: Biochemistry, Chemistry, Health sciences

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