Regulatory Affairs for QA: Variations Training
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About This Course
Our regulatory affairs for quality assurance (QA) professionals’ training is an interactive refresher course focused on the variations in process requirements and categorizations found in the EU, UK and US. It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for variations to EU marketing authorisations (MAs) and post-approval changes to US. New Drug Application (NDA)/Abbreviated New Drug Application (ANDA)/Biologics License Application (BLA) submissions.
During our training course, we explore:
- Regulatory agency expectations on the data that should be included in variations
- The categorization of post-approval changes, e.g. 1A, 1B and Type 2 in the EU and CBE0, CBE30 and prior approval in the U.S.
- 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 the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12
Key Learning Objectives
By the end of this regulatory affairs training, QA professionals will improve and expand their:
- Awareness and knowledge of the latest regulatory procedures for post-approval changes
- Knowledge on how EU, UK and US regulatory procedures work
- Ability to communicate with their regulatory support functions
