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.



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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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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A voz das pessoas com doenças raras na EuropaEURORDIS A voz internacional das pessoas com doenças raras, Rare Diseases InternacionalRare Disease International Reúne doentes, famílias e especialistas para partilhar experiências num fórum multilinguístico. RareConnect O programa Rare Barometer é uma iniciativa da EURORDIS para a realização de inquéritos para transformar a experiência das pessoas com doenças raras em números e factos que podem ser partilhados com os responsáveis pela tomada de decisões.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Adira ao maior encontro europeu das partes interessadas no âmbito das doenças raras na Conferência Bienal Europeia sobre Doenças Raras e Produtos Órfãos. A ECRD é uma iniciativa da EURORDISEuropean Conference on Rare Diseases