Skip to main content

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) into E2B (R3), the BFC rule maps units (units used in laboratory investigations in reference ranges & results) from the R2 lists, which in turn uses the Unified Code for Units of Measure (UCUM) list. However the list of UCUM units are limited, thus during the conversion if a unit is not mapped then BFC would indicate the unmapped unit using curly brackets {…} hence generating an error.

Similarly, when downgrading an ICSR from E2B (R3) to E2B (R2), extensive information loss may be incurred. Many E2B (R2) fields have limitations in the number of characters that are smaller than E2B (R3) fields. As an example, E2B (R2) narratives have a limitation of 20,000 characters which may cause an issue when downgrading from E2B (R3) file: this limitation in character may lead to the use of truncated symbols like $ * ? inside the narrative. A 10 page case narrative entered in E2B (R3) format would be truncated when converted into E2B (R2) format using BFC as (R2) has a limitation of up to 6 pages of text, thus leading to data loss and loss in quality of the individual case safety reports.

How are BFC tools used for E2B (R3) transmission and what are the alternatives?
Even though these limitations exist, a large number of MAHs / CROs are implementing BFCs in order to be able to import ICSRs from the new EudraVigilance system, as they have not yet upgraded their safety database to an E2B (R3) compliant solution.

However, implementing a BFC tool incurs high additional costs and long work for testing and updating procedures.Moreover, these costs cannot be offset on the long term as BFCs are only temporary solutions, which will not be accepted by the EMA any more in the long run.
We at Think I are committed to provide cost effective & robust pharmacovigilance solutions. Therefore, we chose to opt for a fully E2B (R3) compliant database, rather than investing in an expensive and unreliable BFC as a patch solution.

Think I partners with AB Cube to provide SafetyEasy PV™, a fully E2B (R3) native pharmacovigilance database. SafetyEasy PV™  is a fully evolutive and pre-validated database, hosted and delivered under the SaaS model (Software as a Service) via full web access. Of course, SafetyEasy PV™ also remains fully E2B (R2) compliant and able to manage submissions in R2 format..
AB Cube’s unique model enables us to propose a database which evolves regularly to propose new functionalities and guarantees adaption ahead of any regulation change, with no additional cost charged to our clients for the upgrades.

1.WHY DO YOU NEED A NATIVE E2B (R3) PHARMACOVIGILANCE SOFTWARE ?; AB Cube Platform, Regulatory News; Url:; Last accessed on 12.02.18

2.EudraVigilance change management Url: curl=pages/regulation/q_and_a/q_and_a_detail_000165.jsp&mid=WC0b01ac0580a69263 ;
3.Trainingmodule:Implementing ISO ICSR/ICH E2B(R3); Url: ; Last accessed on 06.02.18
4. The Unified Code for Units of Measure; Url: ; Last accessed on 06.02.18

An Article by:
Joseph Mathew
Senior Manager- Think i

For more details, contact us at +91 9560102587, +91 9810068241 or email us at   or simply visit



Popular posts from this blog

Pharmacovigilance system- Industry perspective, Market size and Operations

Monitoring adverse drug reaction is an essential component in patient safety. In the last decade we have seen how technology has influenced the entire healthcare system, leading to patient awareness, thus making the pharmaceutical companies and regulatory authorities to invest more time and resource in monitoring adverse events.
Pharmacovigilance as per WHO is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Pharmacovigilance is the study of adverse events taking into account all the plausible relationship or untoward medical occurrence which the patent experienced after taking the drug and then using standard set of coordinated activities which involves first collecting adverse event reports either via telephone, email, social network, lay press , media. After adverse event reports are filed we then process and assess these reports in database to determine if indeed these adv…

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…


European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training.
The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions.
We at Think I are also driven to produce Pharmacovigilancesafety  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 more details, contact us at +91 9560102587, +91 9810068241 or…