Tag: Clinical Trials

Young Patients Training

ERDERA opens call for young rare disease advocates to join training in Paris

Taking place on 23–25 April at Institut Imagine in Paris
Scientific paper

Human genomics technologies in clinical studies – the research landscape: report on the 1990–2024 period

Published on 14 December, this WHO technical document maps global trends in registered clinical studies using human genomic technologies from 1990 to 2024, including patterns of inclusion and equity.
EMA

Webinar on the use of platform technologies in the non-clinical and clinical domains

dna-8895875_1280

New WHO report highlights gaps in human genomics research

Greater efforts are needed to invest in infrastructure, foster inclusive study designs and align research agendas.
European Medicines Agency (EMA)

ICH opens consultation on draft E22 guidance for patient preference studies

A draft ICH E22 guideline on patient preference studies is now open for public comment via the European Medicines Agency until 12 April 2026.
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.
Picture for the website (1)

New survey launched to improve rare diseases clinical trial enrolment

The RealiseD project launched a new multi-stakeholder survey that invites the rare disease community to share insights and help improve clinical trial enrolment
RealiseD webinars

RealiseD webinar series: Helping re‑shape rare disease clinical trials

13 January – 10 February 2026 | Online webinar series to advance best practices in clinical trial design for rare and ultra rare diseases.
Publication cover image

ICH E22 Guideline on general considerations for patient preference studies

Open for consultation from 12 December to 12 April, this draft ICH guideline sets out how to design and submit robust patient preference studies to inform regulatory decision‑making across a medicine’s lifecycle.
Non-human primate hand via pickpik.com (CC0)

EMA public consultation on non‑human primate use in safety testing

EMA seeks stakeholder input on new reflection paper to reduce and replace non‑human primate use in medicines safety testing through 3Rs approaches.
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