- About EURORDIS
- About Rare Diseases
- Rare Disease Policy
- Orphan Drugs & Treatments
- What is an orphan drug?
- Improve the safety of your medicines
- Compassionate Use
- Role of EURORDIS
- Patient advocates involvement
- Access to orphan drugs
- Health technology assessment
- EURORDIS Round Table of Companies (ERTC)
- List of the latest marketing authorisations and orphan medicinal products designations
- Living with a Rare Disease
- Services & Trainings
- Get involved
- News & Events
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.
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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The voice of rare disease patients in Europe
The international voice of people living with rare diseases
Bringing together patients, families and experts to share experiences in a moderated multi-language forum.
The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.
An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiative
Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiative
The international voice of people living with rare diseases
Bringing together patients, families and experts to share experiences in a moderated multi-language forum.
The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.
An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiative
Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiative