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
