How to submit variations in Europe MasterClass

  • 16 Sep 2021
  • Online Event

Description

The How to submit variations in Europe MasterClass covers topics such as:

  • Differences between change categories (Type IA, IB, II)
  • Overview of the European legislation on variations
  • Content of a variation dossier
  • Impact of a change on the CTD dossier

The How to submit variations in Europe MasterClass intended for:

  • Regulatory Affairs CMC authors or reviewers
  • Regulatory Affairs Professionals
  • Quality assurance specialists
  • Project managers with CMC responsibilities
  • Analytical and stability laboratory managers (R&D through GMP)
  • Chemistry, Manufacturing & Controls (CMC) regulatory

Past Events

Important

Please, check "How to submit variations in Europe MasterClass" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical technology

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