Regulatory Affairs for QA: Marketing Authorizations Training
About This Course
This interactive pharmaceutical regulatory affairs training is a refresher course focused on the structure and content of a common technical document (CTD) and application routes specifically designed for QPs and other quality assurance (QA) professionals.
It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for marketing authorization application (MAA)/New Drug Application (NDA) submissions in the EU, UK and US. and other world markets. Our course is also relevant to medicinal products containing small molecule drug substances, biologics, generics and biosimilars, drug device combinations and borderline products.
During the course, we explore:
- Regulatory agency expectations on the data that should be included in an eCTD
- What can (and often) goes wrong when too much or the wrong information is registered
- The role of the QP/QA in managing what is registered
- New/emerging chemistry and manufacturing and controls (CMC) requirements
Key Learning Objectives
By the end of your pharmaceutical regulatory affairs training you will improve and expand your:
- Awareness and knowledge of the latest regulatory procedures and CMC requirements for major market submissions
- Knowledge on how different regulatory procedures work
- Understanding of some of the differences between EU, UK and US. CMC requirements
- Ability to communicate with your regulatory support functions
