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RSSThese background rate data are part of the work done by the EMA-funded ACCESS (vACcine Covid-19 monitoring ReadinESS) project led by the University Medical Center Utrecht and Utrecht University.
The composition of the new ENCePP Steering Group for 2021-2023 has been published on the ENCePP Steering Group page.
The ENCePP webinar will discuss new challenges to be addressed by the ENCePP network and establish the new ENCePP Steering Group.
A workshop on the draft guideline on registry-based studies scheduled for Monday, 19 October 2020 from 12:30-17:00 (CET) has been announced on the EMA website.
The 8th revision of the ENCePP Methods Guide has been published on the ENCePP website.
The EMA published a press release on 26 May 2020, calling for for high-quality observational research in the context of COVID-19.
In these exceptional circumstances, many research groups in Europe and around the world have started or are planning observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic.
The European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.
A new ICH-E19 draft guideline on the optimisation of safety data collection in interventional clinical trials and non-interventional studies has been published by ICH for public consultation.
The 1,500th study was registered in the EU PAS Register (study EUPAS29415) in April 2019. By facilitating the review of protocols and results, the EU PAS Register is also increasingly used for academic research.