The European Medicines Agency called for expressions of interest to participate in the Data Standards Strategy Initiative, launched by The Big Data Steering Group, by providing feedback through a survey and taking part in the virtual data standards workshop scheduled on 18 May. This call for expression of interest was dedicated to patients’ and healthcare professionals’ organisations or Learned Societies.

The Data Standards Strategy Initiative aims to enable the Network to more effectively leverage data to deliver evidence in support of benefit-risk decision-making on the development, authorisation and use of medicines. The joint European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Big Data Steering Group advises the EMA Management Board and HMA on prioritisation and planning of actions to implement the ten priority recommendations of the Big Data Task Force. 

The survey aimed to gather input regarding the application and use of Data Standards within the EU Regulatory Network. The results of the survey closed on 23 April 2021 and use cases received were integrated into a draft Data Standards Strategy document aimed to define a roadmap for the development and implementation of data standards. This strategy will be presented and discussed during a virtual workshop on 18 May 2021.