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Regulatory Affairs for QA and QPs Workshops

One of the primary roles for Qualified Persons (QP) and other quality professionals is to make sure that the products released for sale are in compliance with the requirements of the marketing authorisation (MA) for that product.

It, therefore, follows that QPs need a solid understanding of how MAs are constructed and applied for initially and how they are kept up to date by the submission of variations.

The following two workshops are designed for QPs and quality assurance (QA) teams to ensure that they have a firm understanding of these two areas.

The workshop on MAs will cover:

  • Regulatory agency expectations on the data that should be included in an electronic common technical document (e-CTD)
  • What can go wrong when too much/the wrong information is registered
  • The role of the QP/QA in managing what is registered
  • New/emerging chemistry manufacturing and controls (CMC) requirements

The workshop on variations will cover:

  • Regulatory agency expectations on the data that should be included in variation
  • The categorisation of post-approval changes such as 1A, 1B and Type 2 in the EU and CBE0, as well as CBE30 or prior approval in the US
  • The need for the QP/QA to be kept informed regarding post-approval changes via an effective change control process
  • New/emerging expectations arising from International Conference on Harmonisation (ICH) Q12

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