The European Medicines Agency
(EMA) announced on March 23, 2017 that, along with heads of medicines
agencies in the European Economic Area (EEA), it was establishing a taskforce
to evaluate the use of big data to support pharmaceutical research, innovation,
and development. The taskforce will be evaluating data from electronic health
records, genomics, social media, clinical trials, and adverse
reaction reports to assess the potential for these data to help in the
determination of the risk and benefits of medicines over their lifecycle.
The taskforce will be chaired
by the Danish Medicines Agency and EMA and include staff from regulatory
agencies in the EEA. The group will be mapping sources and characteristics of
data, explore applicability and impact of data on regulation, and develop
recommendations for changes to legislation or guidelines. They will also
collaborate with regulatory authorities outside the EEA to gain further
insight.
Posted by Dr. Tim Sandle
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Pharmaceutical Microbiology