News

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published a procurement procedure today for setting up a framework to support better decision-making throughout the lifecycle of medicinal products.

In its CONSIGN-International document, the Consortium describes ongoing initiatives and opportunities for international collaboration in the area of medicines use and their effects on management of COVID-19 in pregnancy.

The European Medicines Agency has published three Seconded National Expert (SNE) positions. Deadline for applications: 28 April 2021.

EMA is holding an ENCePP webinar on 8 March from 10.00 to 12.00 for Academia communities / Learned societies to gain a better understanding of what ENCePP is and how it contributes to improving pharmaco-epidemiological research especially in circumstances such as a pandemic.

These 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.

The meeting report and presentations from the ENCePP webinar (organised by Agenzia Regionale di sanità Toscana) have been published.

For more than 10 years EMA has been at the forefront of scientific independence and transparency in real world data studies through ENCePP.

The ENCePP Secretariat has published a summary of the network's activities in 2018.

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018.

The EMA cross-committee task force on registries has published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes.