Introduction to Regulatory Affairs in drug development – for life science researchers

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.

When developing new medicines, the key to success is to ensure compliance with the regulatory and official requirements at all stages of the research and development process. Getting it right from the start saves time and money and is often the difference between success and failure.

Target audience:

The training day is primarily aimed at those who work in the smaller research-based pharmaceutical company and need a 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.

Course objectives:

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