Section outline

  • After completing this 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
     

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