Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...
Posted by Michael Wonder on 25 Jul 2023
Paving the way towards coordinated clinical trials in public health emergencies in the EU
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...
Posted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 01 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
Posted by Michael Wonder on 30 Aug 2022
Accelerating clinical trials in the EU: publication of 2022-2026 workplan
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 21 Apr 2021
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21 April 2021 - EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...