Common Technical Dossier

  • Feb 2023

Description

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

Common Technical Dossier 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

Common Technical Dossier brings together:

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

Common Technical Dossier might be held in Feb 2023.

More Details

Prices:
1099 Pound Sterling (Estimated)
Organizer:
Management Forum
Website:

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Important

Please, check the official event website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Industry: Chemical
Science: Health sciences, Life Sciences & Biology

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