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Eurordis - Rare Disease Europe


Medical Regulatory Framework and Procedures

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All aspects within the medicines development process are subject to various degrees of regulation. In this course, you can learn more about the legal framework, guidelines, health authorities’ attitudes and requirements, which have a significant influence on the development process and its success rate. As patient advocates and researchers, it is important to understand the basic principles of regulatory affairs in order to be able to interact proactively with regulatory authorities.

To complete this course, you need to read through all the lessons below. At the end of the course, once you have taken the final quiz, you will be able to download and print your certificate of completion.