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RSSENCePP Plenary webinar
The 10th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology by the ENCePP Research Standards and Guidance working group has been published under EMA’s coordination.
A list of metadata describing real-world data sources and studies has been publish on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
The European Medicines Agency (EMA) is seeking to sign multiple framework contracts in three different lots for developing a Big Data Curriculum to enhance the skills of the EU regulatory network.
An article written by ENCePP WG3 has been published with an overview of 1426 studies registered in the EU PAS Register from inception to December 2018. The authors provide suggestions on how to improve the register.
The joint HMA-EMA Data Standardisation Strategy (DSS) following its endorsement by the Heads of Medicines Agencies in November and EMA Management Board in December 2021 has been published.
The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021.
Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.
The 9th Revision has been extensively amended and re-organised with an improved structure. The foreword from the co-chairs of the ENCePP Steering Group highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns.
The European Medicines Agency has published a new Call for tenders for Real World Data Subscription
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.