European Alliance for Vision Research & Ophthalmology

Clinical Trials

The new EU Clinical Trials Regulation (Regulation No. 536/2014) will come into force in 2019.  The regulation aims at streamlining and simplifying rules in order to revive research activity in Europe, for example by introducing a unified application process through a single EU portal for cross-border trials.

Simplification of rules include:

• Streamlined application procedure via a single entry point – an EU portal and database, for all clinical trials conducted in Europe;
• Single authorisation procedure for all clinical trials, with assessment of application by all Member States concerned, with one single assessment outcome and authorisation per Member State;
• Extension of the tacit agreement principle to the whole authorisation process for more legal certainty for sponsors, researchers, SMEs and academics;
• Strengthened transparency for clinical trials data and new rules for informed consent for use of subjects’ data

For more information and for accessing documents in your language:

• European Commission: Clinical Trials – General Information
• Clinical Trials Regulation
• Clinical Trials guidelines
  • EMA Scientific guidelines
• EU Clinical Trials Register

Clinical Trial Facilitation Group (CTFG)

European Open Science Cloud

The European Open Science Cloud (EOSC) is a network of organisations and infrastructures from various countries and communities that supports the open creation and dissemination of knowledge and scientific data.  The EOSC is part of the European Commission’s strategy to open up European research and innovation systems as expressed in the policy initiative Open Innovation, Open Science and Open to the World.

EU EYE applauds the move towards Open Science and the implementation of European Open Science Cloud and calls for the strengthening of the representation of the medical community within the Open Science Policy Platform to address the diversity in open data needs in healthcare. Download here

European Research Area

The European Research Area (ERA) was launched in 2000 as a unified area open to the world. The ERA is defined by the free circulation of scientific knowledge, technology and researchers. Such integration of scientific resources of the European Union aims to establish common research agendas and infrastructures, optimise transnational cooperation and create new business by opening the labour market for researchers. Member States are aligning to the ERA principles launching new Knowledge Alliances – transnational and cross-sectoral result-driven projects between higher education and business open to any discipline. Projects under this label are joint master degrees, sector skills alliance, etc

 

 

HORIZON Europe

Horizon Europe is the EU’s key funding programme for research and innovation for the period 2021-2027 with an indicative budget of € 93.5 billion.

Horizon Europe Work programme (2023-24) – Cluster 1