Planning for the New Individual Case SafetyReport (ICSR) International Standard &Upcoming ICSR Reporting ChangesAndrew Mit...
Welcome and IntroductionsAndrew MitchellEuropean Practice LeadSafety ManagementBioPharm Systems, Inc.• 9 years experience ...
Agenda• Acknowledgements• Identification of Medicinal Products (IDMP) Standards– IDMP (ICH M5 Guideline)– IDMP Timeline• N...
AcknowledgementsThis webinar includes information shared during theEuropean Medicines Agency meeting,held in London on 5th...
IDMP (ICH M5 Guideline)• We must accurately IDentify Medicinal Product(s)involved in adverse events– In order to do this, ...
IDMP Standards• IDMP has five standards– DIS ISO 11615: Medicinal Product Information(MPID)• Marketed Product (Trade Name ...
IDMP Timeline• November 2003– Concept Paper approved for development of tripartiteguideline– ICH M5 Data Elements & Standa...
New ICSR Standard: E2B(R3)• Aim to improve Pharmacovigilance standardsacross ICH regions– Advances in Pharmacovigilance sc...
E2B(R3): Highlights• Single Report for Multiple Recipients– Generates Multiple Acknowledgements• Include Case Attachments–...
E2B(R3): Current Status• ICSR E2B(R3) Standard– April to June 2011: Final Draft International Standard(FDIS) ballot expect...
E2B: XML v HL7 Messaging
EU Implementation Guide• Additional information required includes– Advanced therapies– Medicinal product defects– Counterf...
EU: Historical Drug Info• B.1.8 Relevant Past Drug History• B.1.10.8 Relevant Past Drug Parent History– To be treated iden...
Anticipated Argus Change◦Historical
Predicted Oracle Roadmap• E2B(R3) functionality scheduled for 2013release:– Products under Application Unlimited• Oracle A...
Planning Ahead• Electronic Submission of Non-Serious AdverseEvents– Smaller companies should consider investing inautomate...
Q&A Session
+1 (877) 654-0033 or +44 (1865) 910-200amitchell@biopharm.comwww.biopharm.comPartner with an ExpertThank you for attending...
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Planning for the New Individual Case Safety Report (ICSR) International Standard & Upcoming ICSR Reporting Changes

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Planning for the New Individual Case Safety Report (ICSR) International Standard & Upcoming ICSR Reporting Changes

  1. 1. Planning for the New Individual Case SafetyReport (ICSR) International Standard &Upcoming ICSR Reporting ChangesAndrew MitchellSafety Management Practice Lead, EMEAOracle Argus Safety:
  2. 2. Welcome and IntroductionsAndrew MitchellEuropean Practice LeadSafety ManagementBioPharm Systems, Inc.• 9 years experience of hands-on implementations ofArgus Safety and EDC systems– Relsys: European Project Manager, Global Professional Services• Managed over 30 related implementation projects
  3. 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. 4. AcknowledgementsThis webinar includes information shared during theEuropean Medicines Agency meeting,held in London on 5th April, 2011These meetings are organized by DIA (www.diahome.org)
  5. 5. IDMP (ICH M5 Guideline)• We must accurately IDentify Medicinal Product(s)involved in adverse events– In order to do this, we need unique & unambiguousidentification of• Active substance• Units of measure• Ingredients• Dosage forms• Units of presentation• Route of administration– Will be required for marketed products and optionalfor investigational products
  6. 6. IDMP Standards• IDMP has five standards– DIS ISO 11615: Medicinal Product Information(MPID)• Marketed Product (Trade Name or Licence)– DIS ISO 11616: Pharmaceutical ProductInformation (PhPID)• Pharmaceutical Product (Global Product)– DIS ISO 11238: Substances– DIS ISO 11239: Pharmaceutical Dose Forms,Unites of Presentation, Routes of Administrationand Packaging– DIS ISO 11240: Units of Measurement
  7. 7. IDMP Timeline• November 2003– Concept Paper approved for development of tripartiteguideline– ICH M5 Data Elements & Standards for DrugDictionaries• May 2005– Guidelines released for initial consultation• 2006– Decision take to develop in collaboration withStandards Development Organizations (SDO’s)• Current Status– Final Draft International Standard (FDIS) ballotresults due Q3 2011 with publication expected tofollow
  8. 8. New ICSR Standard: E2B(R3)• Aim to improve Pharmacovigilance standardsacross 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 tojointly develop standards– FDA required single standard for all product typesregulated by the FDA to meet HL7 standard– EU & Canada required standard to be ISO or CEN in orderto be incorporated into their legislation– ICH developing Implementation Guide to define use of thestandard– EU Implementation Guide
  9. 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. 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 maybe required by some national authorities by June 2012– Single reporting to EMA expected 2015
  11. 11. E2B: XML v HL7 Messaging
  12. 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. 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 andtreatment products– Include:• Substance / Specified Substance• Drug Dosage information• Pharmaceutical Dose form• Route of Administration
  14. 14. Anticipated Argus Change◦Historical
  15. 15. Predicted Oracle Roadmap• E2B(R3) functionality scheduled for 2013release:– 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. 16. Planning Ahead• Electronic Submission of Non-Serious AdverseEvents– Smaller companies should consider investing inautomated 3rd party gateway software such as AxwayInterchange (formally Cyclone) or bTrade rather thanrelying on the EV Web Trader• E2B (R3) Compliant Safety System– Oracle Argus Safety or ARISg– Will need to upgrade to a compliant version or switchsystems– If migration is required, it’s recommended to do thisearly to reduce the size of the project, risk and spreadthe financial impact of these compliance changes
  17. 17. Q&A Session
  18. 18. +1 (877) 654-0033 or +44 (1865) 910-200amitchell@biopharm.comwww.biopharm.comPartner with an ExpertThank you for attending!This presentation will be available for download fromwww.BioPharm.com within 24 hoursWrap-up and FeedbackAndrew MitchellSafety Management Practice Lead, EMEA

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