Your Tag: Regulatory

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Information Webinar – ERDERA Joint Transnational Call 2027

December 14 @ 3:00 pm - 4:00 pm
This information webinar on the 2027 Joint Transnational Call for Proposals is scheduled for 14 December 2026.
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.
ERDERA trainings template (9)

The 2027 Open Academy x ERDERA Schools is now open for application

Applications for the 2027 Open Academy x ERDERA Schools offer patient advocates and early-career researchers the opportunity to strengthen their knowledge and participation in rare disease research.
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.
ECRD 2026

ECRD 2026 in Prague strengthens the push for a coordinated EU Action Plan on rare diseases

On 3–4 June, EURORDIS–Rare Diseases Europe and Orphanet convened the rare disease community at ECRD 2026 in Prague around a shared call for coordinated European action, including the forthcoming European Blueprint for Rare Diseases.
BMC Medical Ethics

Ethics and regulatory guidance to address the challenges encountered in research on rare diseases in a multinational dimension: the experience of a European funded programme

This BMC Medical Ethics article examines ethics and regulatory guidance across EJP RD-funded rare disease research projects.
Female scientist in protective gear using lab equipment for research.. Photo by ima Miroshnichenko via Pexels (CC0)

Biotech Act II: European Commission opens Call for Evidence on industrial biotechnology and biomanufacturing

The European Commission has opened a Call for Evidence on the upcoming Biotech Act II — with feedback open until 10 June 2026, inviting stakeholders to submit input that will help shape the initiative before a legislative proposal is prepared.
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EMA launches consultation on proof-of-concept data in paediatric oncology

This initiative is also highly relevant from a rare diseases perspective, as paediatric cancers are rare conditions where small patient populations make robust non‑clinical proof‑of‑concept data essential for responsible and ethical trial initiation.
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Towards animal-free testing: virtual control groups gain regulatory acceptance

For rare diseases, where research often relies on limited animal models and small development teams, the regulatory acceptance of virtual control groups could help streamline early non‑clinical studies while maintaining a strong focus on patient safety.
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