Basics of Regulatory Affairs
About the course
Are you looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs gives a comprehensive picture and is a platform for your further development in the area. The course is given in English.
Who should attend?
This course is perfect if you are new in your role within Regulatory Affairs and need an overview of current regulations, processes and documentation. It also suits you who hold more experience within the Regulatory Affiars field and are looking to update or confirm your knowledge. In addition, it’s an opportunity to exchange experience and best practises with colleagues regarding e.g. practical application of current regulations and guidelines.
Learning objectives
The course gives a comprehensive picture of Regulatory Affairs. After the course, you will have a broad knowledge of Regulatory Affairs and a platform for further development in the area.
The course gave a perfect overview of all areas that concern RA
The possibility to follow the course online, worked really well
Nice and dedicated lecturers with extensive experience and expertise in their respective areas
Course instructors
Course outline
The course days are structured around lectures and discussions – individually and in groups. From the program:
- Overview of European regulations
- The authority role
- Regulatory Affairs role in pharmaceutical development
- Development phases, from selection of substance to market authorisation approval
- Approval Procedure
- Product life-cycle management
- Variations and line extensions
- Market authorisation application: structure and content
- Product information
- Practical application and discussions
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