This is the training day for those who need an up-to-date overview of current regulations and how to ensure adequate regulatory documentation in all phases of a drug development project with a focus on early phase.
The course will be held on four occasions in Umeå, Linköping, Lund and Stockholm in 2016.
The training day is primarily aimed at those who work in the smaller research-based pharmaceutical company and need comprehensive knowledge of Regulatory Affairs: project managers, project team members, innovators and entrepreneurs, academic researchers, drug developers and management working in research-based pharmaceutical companies.
The training day provides an overview of the field of Regulatory Affairs, to give you an understanding of the regulatory requirements you may face in drug development.
Course content and structure
The training day is structured around lectures. As a participant, you will be given the opportunity to submit in advance any questions you wish to have addressed. This will be addressed during the course:
- Innovation support
- Terminology and regulations
- Application for authorization of a medicinal product
- The role of Regulatory Affairs in drug development
- Clinical trials/regulations and authorizations
- Product life cycle