Key Takeaways
- The EU Big Data Steering Group (BDSG) has issued a report on the potential advantages and challenges of leveraging social media data in regulatory decision-making.
- The report recommends a series of actions for EU regulators to help establish the value of social media data and enable its use in medicines regulation.
- The BDSG says it is crucial for regulators to tackle the issue given the increasing trend of companies exploring the use of social media data to support their regulatory submissions.
- European Medicines Agency’s regulatory pipeline database shows that companies have used, or plan to use, social media data for patient recruitment, data collection, to justify study designs and for pharmacovigilance activities.
Ongoing efforts in the EU to expand the availability of real-world data (RWD) sources for regulators have resulted in a growing
It has prompted EU Big Data Steering Group (BDSG) to recommend a range of actions, including launching proof-of-concept studies, to help evaluate if social media data can
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