Policy Paper published by ICMRA on Big Data Analytics; Experts from EMA, Health Canada & MHRA to examine the opportunities and limitations of Big Data and Analytics in Pharmacovigilance.
The International Coalition of Medicines Regulatory Authorities’ (ICMRA) has released a policy paper which examines strengths and limitations of big data and analytics in pharmacovigilance.
The working group of the ICMRA comprising of subject matter experts from European Medical Agency (EMA), Health Canada and Medicines and Healthcare Product Regulatory Agency (MHRA) had developed the policy paper with a list of initiatives pertaining to the implementation of big data analytics in pharmacovigilance.
‘Big Data’ is a sub group of ICMRA working group.
One of key areas in exploring the opportunities with big data and analytics would be in the spontaneous reporting system (SRS) which currently contains limited structured / unstructured data.
Data collected through voluntary reporting, often has its own challenges with limited information available about patient’s demographics, medical history, past drug history, concomitant therapies, onset date and time of adverse event and it becomes difficult to determine the incident rate of ADR, total number of ADR occurring in the population and the patient exposure.
The members from the expert committee of ICMRA working groups have agreed to share their knowledge in identifying gaps and thus contributing regulatory harmonization.
Of the many recommendations made from Big-data sub group members to the ICMRA. Key recommendations included that all ICMRA members should be invited to share the results of research and validation studies on big data sources, along with real-world data, EHR, EMR and AHD with traditional SRS data when developed.
Big Data and Pharmacovigilance: ICMRA Working Group Looks at Opportunities and Challenges
https://www.raps.org/news-and-articles/news-articles/2018/2/big-data-and-pharmacovigilance-icmra-working-grou Last accessed on 16.02.2018
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