From EMA for Pharma SMEs: Updated User Guide
Wien, 15.02.2024 – Text: Catarina Carrão On the 23rd of January 2024, the European Medicines Agency (EMA) released a major revision of its user guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector. The revised guide offers a comprehensive view on the European Union (EU) legislative framework for medicines, outlining requirements for the development and authorization of medicines for human use. Take a look at the […]
EUDAMED Gestalt
Wien, 17.01.2024 – Text: Catarina Carrão EUDAMED: basics The European database on medical devices (EUDAMED) is an information technologysystem being built and implemented by the European Commission (EC) to fulfil many of the obligations of the Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR EU 2017/746). It serves a fundamental […]
How does the EU AI Act influence clinical trial development?
Wien, 20.12.2023 – Text: Catarina Carrão The EU AI Act The Council presidency and the European Parliament have agreed on a provisional agreement on the proposal for harmonized rules on Artificial Intelligence (AI), known as the AI Act. The draft regulation aims to guarantee the safety and adherence to fundamental rights and values for AI systems in the European Union […]
