Implementing ISO ICSR/ICH E2B(R3) Training Module PhV-M2b Submodule b: backwards and forwards conversion - impact on adverse reaction reporting
An agency of the European Union
Summary Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
1
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
2
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction: Target audience • Target audience for this training module: − National Competent Authorities (NCAs) in the European Economic Area (EEA) − Marketing authorisation holders (MAHs) − Sponsors of clinical trials (Sponsors) − Research institutions/Academia − Other interested parties
3
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction •
The ICH E2B(R3) Implementation Working Group developed guidance on how to convert between the E2B(R2) and E2B(R3) Individual Case Safety Report (ICSR) formats
•
ICH has published two documents as part of the ICH E2B(R3) ICSR Implementation Guide
•
4
•
ICH ICSR Backwards and Forwards Compatibility Recommendations
•
Backwards and Forwards Element Mapping spreadsheet
In addition, the above recommendations and mappings have been used to create the ICH Backwards and Forwards conversion tool (BFC) Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction: Learning objectives Following the completion of PhV-M2b training module you should be able to understand: The background about the conversion tool How to perform a conversion The issues that may be experienced after converting files 5
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
6
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
ICH Backwards Forwards Conversion Tool •
The ICH backwards and forwards conversion tool has been built using eXtensible Stylesheet Language Transformations (XSLTs)
•
XSLT is a computer language used for transforming XML documents into other XML documents
•
The BFC tool is not a computer application in itself and requires the use of a separate computer program that understands XSLT language to perform a conversion
7
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
EU Backwards Forwards Conversion Tool •
The EU ICSR Implementation Guide contains additional data fields and requirements in addition to the ICH ICSR Implementation Guide
•
In support of EU stakeholders EMA has amended the ICH BFC tool to include the additional fields and requirements introduced in the EU Implementation guide
•
The original ICH XSLTs have been amended and the updated EU version of the BFC tool published on the EMA website (EudraVigilance Change Management page)
8
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
9
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Using the XSLT to perform a conversion • The BFC XSLT package contains 31 files, of these files the following are the key files for performing the conversion • ICSR Conversion • downgrade-icsr.xsl – Converts an E2B(R3) file into an E2B(R2) file • upgrade-icsr.xsl – Converts an E2B(R2) file into an E2B(R3) file
• Acknowledgement Conversion • downgrade-ack.xsl – Converts an E2B(R3) file into an E2B(R2) file • upgrade-ack.xsl – Converts an E2B(R2) file into an E2B(R3) file
10
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Using the XSLT to perform a conversion •
Many programs exist that can use XSLTs to convert one XML format into another
•
An example of a free to download program is MSXSL.exe, this program requires the use of a command line:
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Use of the BFC tool When to use • •
Creating test E2B(R3) files for
When not to use •
Loading E2B(R2) data into an E2B(R3)
development
system – Conversions may issues e.g.
Interim process (survival) to convert
lab test units
E2B(R3) data obtained from EudraVigilance to load into an E2B(R2)
system
•
Long term
•
Converting E2B(R2) files to E2B(R3) for sending to other receivers. Conversions must only be performed by the receiver of the file, not the sender.
Note: A system should not be called E2B(R3) compliant if it uses these XSLTs. It is advisable for your systems to continue to support receiving E2B(R2) ICSRs directly as this format will continue to be used for some time going forward. 12
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Use of the BFC tool •
In accordance with ICH best practice the conversions must only be performed by the receiver of the file.
•
•
In addition, it should be noted that –
The receiver of E2B(R2) message is allowed to return an E2B(R3) acknowledgement
–
The receiver of E2B(R3) message is allowed to return an E2B(R2) acknowledgement
In normal situations the EudraVigilance system will generate E2B(R2) acknowledgements for E2B(R2) ICSRs and E2B(R3) acknowledgements for E2B(R3) ICSRS. –
Note: Invalid error XML/ICSRs submitted in either E2B(R2) or E2B(R3) format will receive E2B(R3) acknowledgments
13
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
14
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
BFC R2 R3 – Note for caution UCUM •
The BFC rule tries to map units from R2 lists to UCUM units, the list of UCUM units used is limited
•
If it can not find a mapping the curly brackets will be used {..} to transfer the data
•
This will cause an issue for converting lab test result units which do not have a published R2 list
•
It may cause issue when migrating data in the future as the values might not be found in approved UCUM lists
15
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
BFC R3 R2 – Note for caution case narrative •
When downgrading an ICSR many field lengths have changed leading to truncations. If a truncation occurs information is copied to the case narrative
•
Case narrative length in R2 is smaller than R3, it is likely that converted files will have case narratives over 20,000 characters
•
This means that a converted file might be rejected by your system’s field length restrictions
16
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Conversion impacts on the data in the ICSRs •
17
Changes can be categorized as follows (see ICH BFC document): •
Date format
•
Code mapping: E2B(R2) and E2B(R3) provide sets of codes for several fields that may have changed or amended
•
Deletion: some fields of E2B(R2) have been deleted in E2B(R3).
•
Addition: some fields have been added in E2B(R3).
•
Field length: some fields have been extended (i.e. increased field length) in E2B(R3).
•
Masking: E2B(R3) provides another way to mask information, for privacy purposes, or because information is unknown.
•
Structure: E2B(R3) provides another way to structure the information that was available in E2B(R2). Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Introduction
Backwards Forwards Tool Using the tool Notes for caution Summary
18
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Summary In this session we have reviewed the following The background about the conversion tool How to perform a conversion
The issues that may be experienced after converting files
19
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Feedback • Please provide us with feedback on this E-learning module and any attendant guidance documents you have viewed by taking the EMA training survey. • The survey is accessible via this link.
20
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Acronyms UCUM – Unified Code for Units of Measure ICH - International Conference on Harmonisation XSLT - eXtensible Stylesheet Language Transformations
21
Implementing ISO ICSR-ICH E2B(R3) Submodule b: Backwards and forwards conversion
Thank you for your attention
Further information European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Follow us on
Implementing ISO ICSR/ICH E2B(R3) - European Medicines Agency
XSLT is a computer language used for transforming XML documents into other ... In support of EU stakeholders EMA has amended the ICH BFC tool to include ... In accordance with ICH best practice the conversions must only be performed by ...
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. â¢. Scanning the horizon for 2016 â 2018. Peter Arlett, EMA.
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 September 2017. EMA/727763/2017. Human Medicines Evaluation Division. List of nationally authorised medicinal products. Active substance(s): dexlansop
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...
Jun 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
