Skip to main content

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

Joseph Mathew
Senior Manager- Think i
We at Think I are committed to provide cost effective & robust pharmacovigilance solutions.
Think I partners with AB Cube, France to provide SafetyEasy PV™ pharmacovigilance database which is fully evolutive and pre-validated, hosted through cloud based technology and delivered through software as a solution (SaaS) in a web based access.


Popular posts from this blog

Eritrea ranked top by UMC- WHO in ADR reporting

Eritrea an African country located in the north east region on the red coast sea bordering Ethiopia and Sudan, has been reported as the top country in reporting adverse drug reaction through safety reports submitted to global database by the Uppsala Monitoring Centre (Sweden), the collaborating centre for WHO as part of their international drug monitoring programme.
The Pharmacovigilance programme of Eritrea was carried out at maturity LEVEL THREE as per UMC with the assistance of local strength engaged in providing harmonization. Eritrea has identified 11 safety concerns on their medicinal products, which were also published in international peer reviewed journals. The Eritrean work on Pharmacovigilance has been globally acknowledged with insights on revising the policy of Eritrean Healthcare system.
Recognizing the significant contribution made in pharmacovigilance,Eritrea along with Netherlands and Peru has been invited for the upcoming 40th Anniversary of UMC on May 18 to share the…

What is an IDMP and its application in Pharmacovigilance?

In response to the demand for internationally harmonized detail of medicinal products, the IDMP which comprises of a set of five ISO norms provides the basis of identifying medicinal products. IDMP standard readily facilitates ICSR (Individual Case Safety Report) submission to regulatory agencies. The message specification in IDMP protects the integrity of medicinal product information when submitting cases to the regulatory agency. HL-7 transmissions are within the IDMP standards Health Level 7- is an international standard for facilitating data exchange between the safety/ clinical database and the regulatory agency. The five ISO norms comprise of ISO 11238 pertains to general characteristics of regulated medicinal products specifying where the product is an active pharmaceutical ingredient or an adjuvant. ISO 11238 also describes the grade of product used (purity, manufacturing information etc.…) ISO 11239 pertains to regulated information on packaging, dosage form, route of administr…

Chat Bot- the first artificial intelligence bot in Pharmacovigilance

Merck Sharp & Dohme (MSD) Corp., a subsidiary of Merck & Co., Inc has developed an Artificial Intelligence (AI) chat bot. The MSD Salute chat bot is designed to aid physicians in providing product information and pathology. 
The Physicians who are registered with MSD would use the Chat bot using facebook messenger.  Chat bot is derived from the social media and uses machine learning and implements feedback to develop interactions. 
Currently MSD is monitoring and not filtering the communication between Chat bot and users, as they want to analyse the open ended exchanges between the AI and the users. Chat bot currently in the testing phase, is said augment patient safety through proactive pharmacovigilance
We at Think I are also driven to produce Pharmacovigilance safety database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 
For mor…