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Your Tag: ATMPs (Advanced Therapy Medicinal Products)

ERDERA Policy Brief

ERDERA Policy Brief: European Biotech Act

The European Rare Diseases Research Alliance (ERDERA), together with the European Reference Networks (ERNs), provides the missing operational layer required to implement the European Biotech Act across the full innovation pathway —from discovery to patient access.
ERDERA News (1)

ERDERA Clinical Trial Call 2026: pre‑announcement and key dates

ERDERA will launch its Clinical Trial Call 2026 (ECTC) on 1 July 2026, supporting multinational, GCP‑compliant early‑phase interventional clinical trials in rare diseases.
ERDERA CTC 2026

ERDERA Clinical Trial Call 2026 – Pre-announcement

Pre-announcement describing scope, eligibility and indicative timeline for the ERDERA Clinical Trial Call 2026, expected to open on 1 July 2026.
ERDERA CTC 2026

Example of costing of Clinical Trial Budget

Budget example showing low and high cost ranges for a Phase 1 rare disease clinical trial with twenty subjects.
ERDERA CTC 2026

ERDERA Clinical Trial Call 2026 – Call Text

Call text draft setting out rules, eligibility and staged application process for the ERDERA Clinical Trial Call 2026. [ERDERA_Cli...t_20260603 | PDF]
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Advancement of Treatments for Rare Diseases

June 16 - June 17
The two-day event will focus on translating research and policy initiatives into tangible benefits for Rare Disease patients through better prevention, diagnosis, and treatment.
the power behind erdera2 (1)

Undiagnosed Day 2026 | Where diagnosis becomes hope: The power of collaboration and technology in rare diseases

April 29 - April 30
This meeting will focus on practical approaches to phenotyping and diagnosis in undiagnosed conditions, including how to define next steps when a diagnosis remains uncertain, and how to strengthen pathways and collaboration around undiagnosed care.
Pharmaceutical products

EU institutions agree next steps on reform of pharmaceutical legislation

Following the 11 December 2025 political agreement, EU institutions are moving towards formal adoption of a new Directive and Regulation that will reshape how medicines—including orphan and paediatric medicines—are developed, authorised and supplied across the European Union.
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Joining the Dots: EURORDIS’ role in ERDERA and the reshaping of rare disease research

EURORDIS champions patient-centred innovation in rare disease research
European Medicines Agency (EMA)

First Italian-made gene therapy for Wiskott-Aldrich Syndrome

On 13 November in Milan, EMA’s expert committee backs Italy’s first home‑grown gene therapy for people in Europe living with Wiskott–Aldrich Syndrome.
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