Regulatory Framework

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

 

Webcasts

In this section, you can access a series of webcasts from the EURORDIS Summer School on the current European regulatory framework for medicines development, storage and distribution.  You can also learn about how regulatory authorities assess quality, safety and efficacy.

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Slideshows

This section contains slide presentations from the EURORDIS Summer School on patient involvement in benefit risk at the European Medicines Agency, how the Pharmaceutical Risk Assessment Committee evaluates medicinal products.

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