The Big Data Steering Group has launched an initiative to develop a Data Standards Strategy that will 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.
If you are part of Patients’ & Healthcare Professionals’ organisations or a Learned Societies, the European Medicines Agency is seeking for expressions of interest from you to participate in this initiative by providing feedback through the survey and taking part in the virtual data standards workshop scheduled on 18 May.
In order to move forward quickly, you can provide them with the following information by the 23rd of April close of business:
- One completed survey per interested organisation: You will find attached the survey questions in a PDF document for ease of dissemination across your members. In addition, here is the link to the online survey (to be opened in Google Chrome)
Please note that the survey should be completed and submitted only once by a designated person for each organisation based on the consolidated input received from its interested members.
- The names and contact details of up to 3 representatives (expert in the field of data standardisation/use, where possible) for each interested organisation to actively participate in the workshop scheduled in May. The number of participants in the virtual room is limited to ensure a smooth running of the virtual meeting.
Note that the workshop will be broadcast live to provide the opportunity for any additional interested colleagues to listen to the discussions
The plan is to consult a wide range of stakeholders to better understand data standardisation needs related to the submission, receipt and (re-)use of scientific data at each stage of the lifecycle of medicinal products. The idea is to optimise the processing of such data by the different stakeholdersthanks to better structured submission formats tailored to their needs while ensuring data security.
The first consultation phase will be done in writing via an online survey to collect feedback on needs and priorities from the different stakeholders’ perspectives. All the input and use cases received will be integrated into a draft Data Standards Strategy document, that will outline a roadmap for the development and implementation of data standards with estimated timelines. This strategy will then be presented and discussed during a virtual workshop on 18 of May 2021.
Important note: The Data Standards Strategy will take into account and align with ongoing projects related to standardisation of data submissions and publication in which you may already be involved (examples: ISO IDMP, ePI, eCTD).
If you have any question do not hesitate to contact DataStandardsStrategy@ema.europa.eu
