1. Planning for the New Individual Case Safety
Report (ICSR) International Standard &
Upcoming ICSR Reporting Changes
Andrew Mitchell
Safety Management Practice Lead, EMEA
Oracle Argus Safety:

2. Welcome and Introductions
Andrew Mitchell
European Practice Lead
Safety Management
BioPharm Systems, Inc.
• 9 years experience of hands-on implementations of
Argus Safety and EDC systems
– Relsys: European Project Manager, Global Professional Services
• Managed over 30 related implementation projects

3. Agenda
• Acknowledgements
• Identification of Medicinal Products (IDMP) Standards
– IDMP (ICH M5 Guideline)
– IDMP Timeline
• New Individual Case Safety Report (ISCR) Standard: E2B(R3)
– E2B(R3): Highlights
– E2B(R3): Current Status
– E2B: XML v HL7 Messaging
– EU Implementation Guide
• Historical Drug Information
• Anticipated Argus Change
• Predicted Oracle Roadmap
• Planning Ahead
• Question and Answer Session
• Wrap-up and Feedback

4. Acknowledgements
This webinar includes information shared during the
European Medicines Agency meeting,
held in London on 5th April, 2011
These meetings are organized by DIA (www.diahome.org)

5. IDMP (ICH M5 Guideline)
• We must accurately IDentify Medicinal Product(s)
involved in adverse events
– In order to do this, we need unique & unambiguous
identification of
• Active substance
• Units of measure
• Ingredients
• Dosage forms
• Units of presentation
• Route of administration
– Will be required for marketed products and optional
for investigational products

6. IDMP Standards
• IDMP has five standards
– DIS ISO 11615: Medicinal Product Information
(MPID)
• Marketed Product (Trade Name or Licence)
– DIS ISO 11616: Pharmaceutical Product
Information (PhPID)
• Pharmaceutical Product (Global Product)
– DIS ISO 11238: Substances
– DIS ISO 11239: Pharmaceutical Dose Forms,
Unites of Presentation, Routes of Administration
and Packaging
– DIS ISO 11240: Units of Measurement

7. IDMP Timeline
• November 2003
– Concept Paper approved for development of tripartite
guideline
– ICH M5 Data Elements & Standards for Drug
Dictionaries
• May 2005
– Guidelines released for initial consultation
• 2006
– Decision take to develop in collaboration with
Standards Development Organizations (SDO’s)
• Current Status
– Final Draft International Standard (FDIS) ballot
results due Q3 2011 with publication expected to
follow

8. New ICSR Standard: E2B(R3)
• Aim to improve Pharmacovigilance standards
across ICH regions
– Advances in Pharmacovigilance science
– Changing requirements
– Improve consistency of use
– Improve accuracy & detail of information
• Formal consultation began in 2005
• New strategy in 2008 to collaborate with SDO’s to
jointly develop standards
– FDA required single standard for all product types
regulated by the FDA to meet HL7 standard
– EU & Canada required standard to be ISO or CEN in order
to be incorporated into their legislation
– ICH developing Implementation Guide to define use of the
standard
– EU Implementation Guide

9. E2B(R3): Highlights
• Single Report for Multiple Recipients
– Generates Multiple Acknowledgements
• Include Case Attachments
– PDF’s of literature articles, lab results, etc..
• IDMP: Structured Drug Information
• Concept of Amendment to E2B(R3)
– Changes following internal assessment
• Too many upgrades could trigger a risk-based inspection
– Corrections
• Reaction / Event level Seriousness
• Additional data, such as
– Drug taken by father
– Drug taken beyond expiration date
– Batch lot tested and found within/not within specifications
– Counterfeit product
– Overdose

10. E2B(R3): Current Status
• ICSR E2B(R3) Standard
– April to June 2011: Final Draft International Standard
(FDIS) ballot expected
– Publication expected Q3 2011
– US Vaccine VAERS reporting requirements added
• ICH Implementation Guide
– Finalization due June 2011
– 6 month consultation
– Approval due Q2 2012
• EU Implementation Guide
– Approval due Q2 2012
• Additional: EU Pharmacovigilance Legislation
– 90 day reporting of all non-serious adverse events may
be required by some national authorities by June 2012
– Single reporting to EMA expected 2015

11. E2B: XML v HL7 Messaging

12. EU Implementation Guide
• Additional information required includes
– Advanced therapies
– Medicinal product defects
– Counterfeit medicines (suspected / confirmed)
– Drug overdose (intentional / accidental)
– Drug misuse (off-label usage)
– Additional Study Identification fields (repeatable)
• Study Registration Number
• Study Registration Country
• So can include EudraCT and National Numbers
– Additional Drug Characteristic value
• Suspect / Concomitant / Interacting
• Drug not administered (for use with clinical trials and medication errors)
• Additions will not lead to rejections in other regions
• Similar additions for FDA Vaccine reporting

13. EU: Historical Drug Info
• B.1.8 Relevant Past Drug History
• B.1.10.8 Relevant Past Drug Parent History
– To be treated identically to suspect, concomitant and
treatment products
– Include:
• Substance / Specified Substance
• Drug Dosage information
• Pharmaceutical Dose form
• Route of Administration

14. Anticipated Argus Change
◦Historical

15. Predicted Oracle Roadmap
• E2B(R3) functionality scheduled for 2013
release:
– Products under Application Unlimited
• Oracle AERS
• Empirica Trace
– Products under Sustained Support
• Oracle Argus Safety v5.x and prior
– Products under Premium Support
• Oracle Argus Safety v6.x
• Oracle Argus Safety v7.x
• Oracle Argus Safety v8.x
– Scheduled New Releases
• Oracle Argus Safety v9.0

16. Planning Ahead
• Electronic Submission of Non-Serious Adverse
Events
– Smaller companies should consider investing in
automated 3rd party gateway software such as Axway
Interchange (formally Cyclone) or bTrade rather than
relying on the EV Web Trader
• E2B (R3) Compliant Safety System
– Oracle Argus Safety or ARISg
– Will need to upgrade to a compliant version or switch
systems
– If migration is required, it’s recommended to do this
early to reduce the size of the project, risk and spread
the financial impact of these compliance changes

17. Q&A Session

18. +1 (877) 654-0033 or +44 (1865) 910-200
amitchell@biopharm.com
www.biopharm.com
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Wrap-up and Feedback
Andrew Mitchell
Safety Management Practice Lead, EMEA