HMA/EMA Joint Big Data Task Force

The main goal of the task force will be to establish roadmap and recommendations for use of big data in assessment of medicines. The task force is chaired by the EMA and the Danish Medicines Agency, their efforts will be complemented on an ad hoc basis by external experts in big data collection analysis.

For the next 18 months, the task force agreed on the following actions:

• Mapping sources and characteristics of big data
• Exploring the potential applicability and impact of big data on medicines regulation and developing recommendations on necessary changes to legislation, regulatory guidelines or data security provisions
• Creation of a roadmap for the development of big data capabilities for the evaluation of applications for marketing authorisations or clinical trials in the national competent authorities
• Collaboration with other regulatory authorities and partners outside the EEA to consider their insights on big data initiatives
• This can be considered a significant development affecting the use of big data in research, innovation and robust medicines development that should be closely monitored by VPH members.

More information can be found here