Lesson 3: Background and general principles of the regulatory approval of medicines
Section outline
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Learning outcomes of this lesson: 
- Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product.
- Explain the concept of benefit-risk and cost-effectiveness
- Describe the various roles patients can play in approval and benefit-risk evaluation pre- and post-approval of medicines
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Students mustΠροβολή
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