News

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.