EU CTR: Transparency
Wien, 15.04.2024 – Text: Catarina Carrão In the end of January 2022, the EU CTR (EU/536/2014) came into effect within the European Union (EU), replacing the EU Clinical Trials Directive (2001/20/ EC). Under the EU CTR, a new EU database – the Clinical Trials Information System (CTIS) was created to provide a single-entry point for […]
EU MDR and The Need For Clinical Evidence
Wien, 12.03.2024 – Text: Catarina Carrão Since the establishment of the EU Medical Devices Regulation (MDR EU 2017/745), Notified Bodies (NBs) have their hands full evaluating the clinical evidence for such products as a critical step for manufacturers to renew or obtain a green door to the European Economic Area (EEA) market. Clinical evaluation: where […]
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 […]
6th November 2023: Reform of the European Union (EU) Pharmaceutical Legislation
Wien, 06.11.2023 – Text: Catarina Carrão Pharmaceutical Legislation Revision: objectives In April 2023, the European Commission (EC) has adopted a proposal for a new Directive and a new Regulation, which revises and replaces the existing general pharmaceutical legislation.1 The purpose is to create a future proof regulatory framework that supports the industry in promoting research and technologies to reach patient’s needs faster, while […]
01. Oktober 2023: Decentralized Clinical Trials and the use of Digital Health Technologies
Wien, 01.10.2023 – Text: Catarina Carrão With the impact of the COVID-19 pandemic, Decentralized clinical trials (DCTs) and digital health technologies (DHTs) gained a momentum in medical research, allowing for clinical study participants to remotely partake in trials using state-of-the-art DHTs.1-3 What are Decentralized Clinical Trials? According to Dr. Leonard Sacks, associate director for clinical […]
21. August 2023: Pragmatic Clinical Trials
Wien, 21.08.2023 – Text: Catarina Carrão Schwartz and Lellouch pragmatic views The Merriam-Webster dictionary defines Pragmatism has a practical approach to problems and affairs.1 In relation to clinical trials, pragmatism surfaced in 1967 with an article from Schwartz & Lellouch, due to concerns that many trials did not adequately inform practice because they were optimized to determine efficacy.2 At the time, authors […]
10. Juli 2023: “Opt-In or Opt-out” The new European Health Data Space
Wien, 10.07.2023 – Text: Catarina Carrão “Opt-In or Opt-out” The new European Health Data Space One year ago, the European Commission proposed a new European Health Data Space (EHDS) legislative proposal to unleash a revolution in health data sharing and set-up a framework for data reuse, while ensuring the protection of this highly sensitive data. The objective is […]
14. Juni 2023: Diversity in Clinical Trial Populations
Wien, 14.06.2023 – Text: Catarina Carrão Historically, there has been an underrepresentation of people from diverse groups in clinical trials, which has created gaps in the understanding of treatment safety and effectiveness across different populations. For example, certain demographic characteristics such as sex, age, race, and ethnicity, can have an impact on how a person […]
