Regulatory procedures- Marketing-Authorisations and their lifecycle management
Topic outline
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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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Learning outcomes of this lesson: 
- 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
-
Learning outcomes of this lesson: 
- 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
-
Learning outcomes of this lesson: 
-
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
-
-
Learning outcomes of this lesson: 
- Describe the EU provisions for early access and use of medicines outside of or without a marketing authorisation
-
-
Regulatory procedures- Marketing-Authorisations and their lifecycle management
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