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Showing posts from February, 2018

What is a ‘backward forward convertor’ ?

Did you know that ICH has a backward forward conversion (BFC) tool which was build using eXtensible Stylesheet Language Transformation (XSLTs) ? This language basically transforms a XML file of a given format into another XML file of a different format. The BFC tool requires a program that understands XSLT language to make conversion of E2B (R2) to E2B (R3) and vice versa. Now considering this, the European medical agency has improvised the BFC tool with additional fields as per the EU implementation guide. The EU version of the amended BFC tool has been published on the EMA website.
The key files in the BFC package includes downgrade-icsr.xsl; which downgrades E2B (R3) file into E2B (R2) and upgrade-icsr.xsl; which upgrades E2B (R2) file into an E2B (R3) file. The acknowledgement convertors include downgrade-ack.xsl and upgrade-ack.xsl What are the technical limitations of BFC tools?
However, the conversion using BFC has some major limitations.
When converting ICSR from E2B (R2) i…

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 …