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Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus Safety


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The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonization (ICH) E2B standard, is an essential component of global drug safety and pharmacovigilance operations.

E2B(R3), the latest version of the ISO ICSR standard, presents a number of challenges that need to be addressed before life sciences companies can implement the essential technology and processes required to perform day-to-day activities and comply with the new regulatory guidelines.

Our webinar delivered insight into the impact of the requirements on your drug safety business processes (e.g., CIOMS reporting, Line Listings, PSURS/DSURS, Signal Generation), as well as to how Oracle's Argus Safety can help you meet the E2B(R3) requirements.

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Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus Safety

  1. 1. Minimize the Impact of E2B(R3) on Drug Safety Operations with Argus Safety
  2. 2. 2 ABOUT PERFICIENT Perficient is the leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting, and creative capabilities, Perficient delivers vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
  3. 3. 3 PERFICIENT PROFILE Founded in 1997 Public, NASDAQ: PRFT 2014 revenue $456.7 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India >2,600 colleagues Dedicated solution practices ~90% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards
  4. 4. 4 OUR SOLUTIONS PORTFOLIO Business Process Management Customer Relationship Management Enterprise Performance Management Enterprise Information Solutions Enterprise Resource Planning Experience Design Portal / Collaboration Content Management Information Management Mobile Safety / PV Clinical Data Management Electronic Data Capture Medical Coding Data Warehousing Data Analytics Clinical Trial Management Precision Medicine Consulting Implementation Integration Migration Upgrade Managed Services Private Cloud Hosting Validation Study Setup Project Management Application Development Software Licensing Application Support Staff Augmentation Training BUSINESSSOLUTIONS SERVICES CLINICAL/HEALTHCAREIT 50+PARTNERS
  5. 5. 5 SAFETY / PHARMACOVIGILANCE SERVICES Implementation Manage implementations and upgrades of off-the-shelf and custom drug safety, pharmacovigilance, signal management, and medical coding systems Integration Build interfaces between safety and clinical systems Training Develop and/or deliver standard and custom training classes and materials Process Guidance Provide insight, advice, and solutions for specific safety/PV issues, based upon industry best practices
  6. 6. 6 WELCOME & INTRODUCTION Indy Ahluwalia Senior Business Consultant Life Sciences, Perficient Prior to Perficient, spent time with Gilead, Amgen, and Eisai in various roles within the drug safety operations business.
  7. 7. 7 AGENDA • Why the need for change • Key changes • Argus Safety 8.x • Q&A
  8. 8. 8 WHY THE NEED FOR CHANGE • E2B was a guideline published by the ICH for electronic reporting of adverse events • Although E2B is a guideline, it is a guideline that is adopted by most health authorities, including the big three (FDA, EMA, and PDMA) • E2B(R3) is the second revision to this guideline • Revamp of E2B is more than just E2B, it has implications on how we collect and code data in order to report in the new format • Aim to improve pharmacovigilance standards • Improve consistency • Improve accuracy and detail of information • Improve robustness • ICH collaborated with SDA (Standards Development Organization) • EMA and Canada require standards to be ISO • FDA require HL7 messaging
  9. 9. 9 WHY THE NEED FOR CHANGE • FDA CBER eVAERS (June) • FDA CDRH eMDR (August) • EMA pilot Jan-Mar • Clinical trial reporting - interim period • PDMA option to submit from Apr • EMA report downloads from EudraVigilance (after audit) • Clinical trial reporting (after audit) • EMA mandatory reporting • PDMA mandatory - Apr 2015 2016 2017 2019
  10. 10. 10 WHY THE NEED FOR CHANGE • It is the receiver of the cases that will need to do the backward-forward change to a R3 message • Some of your partners will deal with FDA CBER • Changes to the way data is collected for the increased scope in R3 • The change to HL7 will affect all data collection systems currently attached to Argus • Most of these changes will not be technical • Argus will support the change to R3, we will need to look at how it will affect our configurations
  11. 11. 1111 KEY CHANGES: HL7 • HL7 (Health Level 7) is a standard for exchanging information between medical applications • The standard defines a format for the transmission of health-related information • This affects the structure of the message being sent, it will no longer be “readable”
  12. 12. 12 KEY CHANGES: HL7
  13. 13. 13 KEY CHANGES: IDMP • IDentify Medicinal Product(s) involved in adverse events • In order to do this, there is a need for unique & unambiguous identification of: • Active substance • Units of measure • Ingredients • Dosage forms • Units of presentation • Route of administration This will be required for marketed products and optional for investigational products.
  16. 16. 16 KEY CHANGES: OIDS • The new standard represents a fundamentally altered message standard compared to the previous E2B version • This technical standard relies on clear identification of code sets and namespaces using numeric Object Identifier codes (OIDs) • OIDs provide unambiguous and clear identification of objects like code lists • A particular OID always refers to a distinct object • That OID will never refer to another object • No two parties can ever assign the same OID to two different objects
  17. 17. 17 KEY CHANGES: OIDS N.1.1 Type of Messages in Batch 2.16.840.1.113883.3.989. C.1.3 Type of Report 2.16.840.1.113883.3.989.
  18. 18. 18 KEY CHANGES: NULL FLAVORS • HL7 provides a means of supporting the management of missing information by communicating a “null” data value along with a coded reason for the omission, known as a Null Flavor • ICH ICSR uses the following codes from the HL7 Messaging Standard to categorize exceptions. Not all Null Flavors are valid for all data types (for example PINF and NINF)
  19. 19. 19 KEY CHANGES: NULL FLAVORS Code Name Code Name NI No Information NA Not Applicable MSK Masked ASKU Asked But Unknown TRC Trace NASK Not Asked NP Not Present NINF Negative Infinity OTH Other PINF Positive Infinity UNK Unknown NAV Temporarily Unavailable
  20. 20. 20 KEY CHANGES: DATE CHANGES Description E2B(R2) E2B(R3) Field Format Field Format Date of birth (patient) B.1.2.1 CCYYMMDD D.2.1 At least to the day Last menstruation period date (patient) B.1.6 CCYYMM CCYYMMDD D.6 At least to the year Date of birth (parent) B. CCYYMMDD D.10.2.1 At least to the year Last menstrual period date (parent) B.1.6 CCYYMMDD D.10.3 At least to the year
  21. 21. 21 KEY CHANGES: AGE GROUP Description E2B(R2) E2B(R3) Field Format Field Format Age group B.1.2.3 • neonate • infant • child • adolescent • adult • elderly C.3.1 • foetus • neonate • infant • child • adolescent • adult • elderly
  22. 22. 22 KEY CHANGES: DATE OF TRANSMISSION Description E2B(R2) E2B(R3) Field Format Field Format Safety Report Version Number 2AN - - Date of this transmission A.1.3 CCYYMMDD C.1.2 CCYYMMDDhhmmss
  23. 23. 23 KEY CHANGES: DRUG ADMINISTRATION Description E2B(R2) E2B(R3) Field Format Field Format Number of units in interval B.4.k.5.4 3N G.k.4.r.2 4N Time interval unit B.4.k.5.5 Year G.k.4.r.3 UCUM Code Month {cyclical}Week Day {as necessary} Hour {total}Minute
  24. 24. 24 KEY CHANGES: DRUG CHARACTERIZATION Description E2B(R2) E2B(R3) Field Format Field Format Characterization of drug role B.4.k.1 • suspect • concomitant • interacting G.k.1 • suspect • concomitant • interacting • drug not administered
  25. 25. 25 KEY CHANGES: AMENDMENTS Description E2B(R2) E2B(R3) Field Format Field Format Report nullification/ amendment A.1.13 Yes C.1.11.1 • nullification • amendment
  26. 26. 26 KEY CHANGES: EVENT LEVEL These fields have moved from the A section to the E section and so will be at an event level: • Reason(s) for Seriousness • Medical confirmation by health professional • Country ID where reaction/event occurred It is important to consider how this will affect CIOMs reporting The EMA have a new form available to include these new sections
  27. 27. 27 KEY CHANGES: ATTACHMENTS R3 supports submission of attachment files within the ICSR message, such as: • PDF of copies of literature articles • Copies of test results
  28. 28. 28 ARGUS 8.x QUICK SHOW & TELL
  29. 29. 29 QUESTIONS?
  30. 30. 30 FOLLOW US ONLINE • • • • Next up: February 18, 2016 Interactive Business Intelligence for Big Data in Life Sciences Business-Intelligence-for-Big-Data-in-Life-Sciences
  31. 31. 31 THANK YOU