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Accelerating Clinical Trials in the EU

Initiatives in Slovenia

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Support mechanisms for non-commercial clinical trials  Level
National EU Level (Multinational) Global
Dedicated webpage        
Training courses Face-to-face trainings have been organised at the Medical Chamber of Slovenia, the University Clinical Centre and at the Oncology institute in Ljubljana.   X  
Scientific advice  Article 29 of the Medicinal Products Act: Zakon o zdravilih (Uradni list RS, št. 17/14 in 66/19)    X  
Helpdesk, regulatory, CTIS and ethics support Regulatory and ethics requirements: In addition to the website, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) provides quick information over phone or email, and offers an initial meeting with any sponsor free of charge.   X  
Other services by National Competent Authority

A 50% discount is available for non commercial sponsors and orphan and paediatric Investigational Medicinal products (IMPs).

For more information: Tarifa Javne agencije Republike Slovenije za zdravila in medicinske pripomočke (Uradni list RS, št. 209/21, 165/22 in 135/23)

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Services by ethics committee

As only one fee is paid by the sponsor, part of the fee for the National Competent Authority and ethics committee(s) is reduced.

A 50% discount is available for non commercial Sponsors, and orphan and paediatric IMPs.

For more information: Tarifa Javne agencije Republike Slovenije za zdravila in medicinske pripomočke (Uradni list RS, št. 209/21, 165/22 in 135/23)

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Public GCP support        
Public research office        
National funding

Grants are available for academia, though not dedicated to clinical research.

For more information: ARIS - Razpisi in pozivi (aris-rs.si)

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Funding coordination and navigation of research infrastructure        
Support identifying research networks        
Other support mechanisms