About this course

After completing the course, you will be able to:
  • Understand the basics of regulatory affairs functions in pharmaceutical companies
  • Understand and explain the principal EU regulatory legal framework and procedures for authorising a medicine
  • Understand and describe the main special cases in marketing authorisations and their particular conditions
  • Explain the non-standard procedures for marketing authorisations and their differences
  • Describe the main variation types of a marketing authorisation
  • Describe and discuss the regulatory steps in a marketing authorisation application (MAA) for a medicine, including the different types of MAAs and their legal basis
  • Describe the EU provisions for early access and use of medicines outside of or without a marketing authorisation
Duration: 8 hours


Start date: 4/11/21

Course files