The TGA is undertaking a Business Improvement Program to update their systems and processes. As part of this, they are starting an Adverse Event Management project to improve how adverse event reports are collected, processed, and analyzed for medicines, vaccines, and medical devices. They outlined the current reporting systems, volumes and formats, and are seeking industry input on capabilities and needs to help design new reporting formats that meet stakeholder and international standards. Interested parties can register for the project by email.

1. Exploring information exchange
opportunities between Industry
and the TGA
ARCS PV Teleconference
Dr Richard Hill and Warren Arndt
Pharmacovigilance and Special Access Branch
PMSBSystems@tga.gov.au
17th November 2015

2. Contents
• TGA’s Business Improvement Programme
• Background
• Adverse Event Management project
• What’s next?
• How to register
• Questions and Answers
Exploring information exchange opportunities between Sponsors and the TGA 1

3. TGA’s Business Improvement
Programme
The TGA is currently undertaking a programme of reform to ensure that it remains
adaptable to both industry and community expectations.
A Business Improvement Programme (BIP) has been established within the TGA
to improve the efficiency and effectiveness of the services provided by the TGA.
The programme includes significant Information and Communications Technology
(ICT) improvements that will support the needs of both the TGA and the
stakeholder community, now and into the future.
The TGA has started an Adverse Event Management (AEM) project under BIP to
improve the current business systems and processes.
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4. Background
• The TGA has separate systems for the collection and processing of adverse
event reports.
• The Adverse Drug Reaction System (ADRS) is used for medicines and
vaccines.
• The Incident Reporting and Investigation Scheme (IRIS) system is used for
medical devices.
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5. Adverse Drug Reaction System
• ADR data collection began 1964
• The ADRS system uses:
– Lotus Notes interface for data entry
– Oracle data repository
• There are over 350,000 individual reports in the database.
• These reports have been received from sponsors, health professionals, state
and territory government and consumers.
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6. Volume of medicine and vaccine reports
Origin of adverse event reports received by the TGA (2010-2014)
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
2010 2011 2012 2013 2014
Numberofreprots
Year
General Practitioners
Hospitals (including
hospital pharmacists)
Community pharmacists
Consumers
Sponsors
State and Territory Health
Departments
Other
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7. How reports are received in ADRS
• Email*, fax and mail
• Telephone i.e. via Adverse Medicine Event Line (NPS) – consumers
• Online forms on TGA website
– Unregistered users
– Registered users
• ADRS Web Service
* Includes emails with E2B structured xml files
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8. Adverse Event Management Project
Scope
The scope of the AEM project includes all therapeutic products (medicines,
vaccines, biologicals and medical devices) for the following activities:
1. The collection and processing of adverse event and problem reports
2. The analysis of information to detect safety signals
3. The review of safety signals identified from adverse event data and other
information sources
4. Associated reporting requirements to support the above activities
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9. Adverse Event Management Project
Key Business Objectives
• Improve the data quality, exchange and reporting of adverse event information
• Streamline the processing of adverse event information
• Reduce the regulatory burden for mandatory reporters of adverse event
information
• Improve the signal detection and management capabilities
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10. Adverse Event Management Project
Expected benefits
• Improved user experience for reporters of adverse event information
• Efficiency gains in processing adverse event reports to handle the continual
increases in volume
• To ensure all reports are collected and stored in a structured format that aligns with
international standards to support data exchange, intelligence and analytics
• Improved and more efficient detection and processing of safety signals
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11. Proposed reporting formats
• System to system transactions
• Online forms on TGA website
– Unregistered users
– Registered users
• Email, fax and mail
• Telephone
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12. System to System - E2B/HL7
• ICH E2BM working group developed a guideline to facilitate the
standardisation of the data elements for the transmission of individual case
safety reports (ICSRs).
• ICH then developed a standard (E2B R2) for the electronic transmission of
ICSRs which used standard generalised markup language (SGML) and a
document type definition (DTD) describing the data elements and their
relationships.
• E2B R3 is the latest standard based upon an HL7 ICSR model that is capable
of supporting message exchange for a broad range of products.
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13. E2B/HL7 cont.
• E2B R3 uses an ‘ICH-subset’ of the data elements within the ISO/HL7 27953-
2:2011 standard
• The ISO/HL7 27953-2:2011 standard is based upon ISO N545 and HL7 ICSR
Release 1 and 2
• HL7 ICSR standard supports the exchange of data and other safety reporting
requirements such as adverse events and product problems associated with
the use of therapeutic products
• ISO/HL7 27953-2:2011 uses HL7 V3 messaging
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14. What next?
The TGA would like to understand the current and planned capabilities of your
adverse event management systems in terms of exchanging adverse event
information. For example, are you exchanging adverse event information in the
E2B R3 format with overseas regulators?
This information will assist us in developing reporting formats under AEMS which
meet our stakeholder needs.
We would also be interested in working with you to identify other potential benefits
e.g. self service capability which you believe could add the most value to your
organisation.
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15. How to register
• You can register your interest in participating in the AEMS project by emailing
your details to PMSBSystems@tga.gov.au.
• The provided details should include:
– Your name
– Organisation
– Email address
– Phone number
Thank you in advance for your time and contribution, we highly value your support
during this process.
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16. Questions and Answers
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