Your Category: Policy and Regulation

ERDERA 2026 Open Session

From individual cases to new treatment pathways: ERDERA Open Session focuses on ultra-rare diseases

ERDERA marked the close of its second year with an Open Session on ultra-rare diseases, bringing together European, regulatory and scientific perspectives on how innovation can reach patients.
Blueprint EU flag

European Blueprint sets out community priorities for a coordinated EU Action Plan on Rare Diseases

EURORDIS’ European Blueprint proposes 18 priority actions across six areas, offering a community-led foundation for a future EU Action Plan on Rare Diseases.
A European Blueprint for Rare Diseases

A European Blueprint for Rare Diseases: Towards an EU Action Plan for Rare Diseases

The European Blueprint sets out how Europe can build on initiatives such as ERDERA to turn existing expertise into a more coordinated future for rare diseases.
erdera policy brief data OCT2026

ERDERA Policy Brief: Making all data count for rare disease research and health outcomes – from policy recommendations to implementation

Making all data count for rare disease research and health outcomes – from policy recommendations to implementation
Genetic Mapping

New clinical trial guidance supports research beyond the hospital

New international guidance supports decentralised clinical trials, pragmatic designs and the use of real-world data.
Irish Presidency of the EU in 2026

Why Rare Diseases Matter for Europe’s Future Embedding Research and Innovation as Standard of Care in Rare Disease

November 13 @ 10:00 am - 5:15 pm
On 13 November 2026 in Dublin, Ireland, this event will explore how research, innovation, patient partnership and EU policy can improve rare disease care and strengthen Europe’s life sciences ecosystem.
European Medicines Agency (EMA)

EMA launches a new pilot to advance innovative methods to animal testing

The voluntary data submission framework allows developers to share data generated using New Approach Methodologies outside marketing authorisation applications and receive tailored, non-binding feedback from European regulatory experts.
Conference "Advancement of Treatments for Rare Diseases" in Cyprus, June 2026

Cyprus conference connects European research priorities with the path to rare disease treatments

At the “Advancement of Treatments for Rare Diseases” conference in Nicosia, European and national policymakers joined clinicians, researchers, regulators, industry representatives and patient advocates to examine how stronger coordination can translate scientific progress into better prevention, diagnosis, treatment and access to care for people living with rare diseases.
ERDERA trainings template

ERDERA launches Ethics & Regulatory webinar series with introductory webinar on ethics across the research continuum

ERDERA’s ethics and regulatory experts are launching a dedicated webinar series to help the rare disease research community navigate two fast-moving areas of biomedical research: Advanced Therapy Medicinal Products (ATMPs) and Artificial Intelligence.
Situating ethics in the research continuum

Introductory webinar: Situating ethics in the research continuum

July 24 @ 3:00 pm - 4:00 pm
This webinar will present a theoretical framework for situating ethics across research activities. The framework will then be brought to life through a relevant case study discussion, giving participants a concrete reference point for the episodes ahead.
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