<Insert Picture Here> Some Background and What You Should Know and Do Now to Prepare

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2 <Insert Picture Here> E2B (R3): Some Background and What You Should Know and Do Now to Prepare

3 The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle s products remains at the sole discretion of Oracle. 3

4 Bio Will Gordon is currently involved in analyzing the coming E2B (R3) and associated IDMP regulatory changes. Will stays in front of the development of industry standards for electronic reporting by serving as a member of the HL7 Patient t Safety working group. He regularly l attends FDA and EMA electronic reporting information meetings to ensure that the latest regulator-supplied information is incorporated into product releases. Will has been with Oracle for six years. Prior to Oracle he held similar roles in software product development strategy and analysis for eight years. 4

5 Topics E2B (R3) Driving to a Better Standard The Making of the New E2B (R3) Standard Standard Development Timelines E2B (R3) Implementation ti Timeline Key Points E2B Backwards and Forwards Compatibility (BFC) Software Versions that Will Support E2B (R3) E2B (R3): Topics for Consideration <Insert Picture Here> 5

6 E2B (R3) Driving to a Better Standard The ICH used E2B (R2) to start electronic reporting of ICSR Good start but the industry now needs more Born in 2001 (a dinosaur by IT standards) ICH realized developing the next E2B standard d needed greater expertise ICH decided to collaborate with an SDO (Standards Development Organization) FDA requires HL7 standard EU (by extension EMA) requires standards to be ISO or CEN There is a recognized need for interoperability and robustness 6

7 The Making of an ISO Standard Committee Draft Internal to ISO Draft International ato a Standard d (DIS) Final Draft International Standard (FDIS) Public technical and editorial comments Public editorial comments only International Standard Publication 7

8 ISO ICSR Timeline Jan Apr Jul Oct Jan Apr Jul Oct Jan 1 st DIS Ballot (Not Approved) 2 nd DIS Ballot (Approved) FDIS Ballot FDIS Ballot Closed ISO Standard!!! (Awarded Dec. 2011) Source: Timeline estimates gathered at EMA ICSR Information Day and ISO standard information from iso.org/iso/search.htm?qt=27953&published=on&active_tab=standards (includes Standards Under Development). 8 8

9 The Making of an ICH Standard Step 1 Consensus Building Step 2 Confirmation of Six-Party Consensus Step 3 Regulatory Consultation and Discussion Step 4 Adoption of an ICH Harmonized Tripartite Guideline Step 5 Implementation Source: ich.org/about/process-of-harmonisation/formalproc.html 9

10 ICH ICSR Timeline Jan Jun Jan Apr Jul Oct Jan Apr Jul Oct R3 Draft Implementation Guide Released R3 Final Draft Implementation Guide Released Start of Consultation Six-Month Consultation Period ich.org/products/electronic-standards.html standards html estri.ich.org/new-icsr/index.htm Step 4 Adoption/Sign-Off (Anticipated Nov. 2012) Source: Timeline estimates based on ICH

11 E2B (R3) Implementation Timeline Key Points ISO standard must be final for ICH to finalize/approve their guideline The ICH step process therefore trailed the ISO process Once ICH finalizes guidelines, member regulatory authorities can adopt the guidance Step 4 expected in November 2012 Regional (member regulatory authorities) will make available their guidance after ICH step 4 EMA guidance anticipated 2Q/3Q 2014 Compliance periods will be identified by regional authorities Assumption is ~18 to 24 months implementation per region Compliance with EMA anticipated sometime in early

12 E2B (R3) Implementation Timeline Timelines Presented Last Year in Toronto Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct ISO Standard!!! ICH Step 4 Adoption/Sign-Off of ISO Standard (Targeted 4Q 2012) EMA Guidance Released ~18 to 24 Months to Comply (By Mid- to Early 2015) Estimates ONLY

13 E2B (R3) Implementation Timeline Assumed Implementation Timeline Jan Jun Jan Jun Jan Jun Jan Jun Jan ISO Standard!!! Completed Dec ICH Step 4 Adoption/Sign-Off of ISO Standard (Targeted 4Q 2012) ICH Step 5 (Implementation) EMA Guidance Released (Possibly (possibly 2Q 2014, likely later in 2014) ~18 to24 ~18-24 months to comply to (by (by Early early 2016) 2016) Future dates are estimates ONLY

14 What You Should Do Now to Prepare Attend this presentation session Read the draft guidance ICH step 4 final guidance anticipated this month Start to plan for E2B (R3)-related projects Create an impact analysis On SOPs, etc. Start to budget for coming calendar years Expect case processing to be impacted Additional data to collect/enter into the case report Backwards and forwards compatibility (BFC) with agencies and trading/marketing partners 14

15 Agency Implementation of E2B (R3) EMA Likely the first to implement the new E2B (R3) HL7 message after IS and ICH adoption is granted FDA Unknown (discussions occurring internally) More to come late Nov emdr (also based on HL7 message) not yet mandatory PMDA Requested sample files from major software vendors to test understanding of HL7 message structure and E2B (R3) Oracle participated and actually did VERY well no errors 15

16 <Insert Picture Here> E2B (R3): Backwards and Forwards Compatibility (BFC) 16

17 What Is BFC? BFC: Backwards and Forwards Compatibility The ability to receive E2B files in either format and convert to the other format for transmission or processing. R2 BFC R3 R3 BFC R2 17

18 E2B Backwards and Forwards Compatibility (BFC) As mentioned, EMA is likely to adopt R3 first Others following at unknown times Both E2B (R2) and E2B (R3) messages will be circulating simultaneously for two to five years, maybe more Backwards and forwards compatibility documentation is being provided by ICH The mapping logic for BFC is contained in XSL style sheets Use of these ICH-defined style sheets will make implementation simpler Download the ICH package zip file and review the BFC.xls file until the light bulb turns on or the penny drops 18

19 BFC Possible Lifetime BFC Need from Implementation in First Region Until Final Implementation EMA Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 FDA Year 1 Year 2 Year 3 Year 4 PMDA Year 1 Year 2 Year 3 BFC Possible Need 19 19

20 BFC Scenarios Ability to accept R2 files and R3 files by same system ReceiptofanR2casefrommarketingpartner R2 case from marketing partner Both R2 and R3 format needed for same case based on destination Note: Scenarios assume company system is R3-capable. 20

21 Oracle Support Policy <Insert Picture Here> Software Versions that Will Support E2B (R3) 21

22 Empirica Trace Support Lifetime by Version Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan 4.1 Jun EMA Guidance Released *3Q 2014 EMA Compliance *Early Jun Apr *Estimated. oracle.com/us/support/library/lifetime-support-applications pdf 22 22

23 Oracle AERS Support Lifetime by Version Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan Feb EMA Guidance Released *3Q 2014 EMA Compliance *Early Jan Sustaining Support *Estimated. oracle.com/us/support/library/lifetime-support-applications pdf 23 23

24 Argus Safety Lifetime Support by Version Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan x Dec Support Was Extended to Dec x Dec EMA Guidance Released *3Q 2014 EMA Compliance *Early x May x 7.0.x May 2016 *Estimated. oracle.com/us/support/library/lifetime-support-applications pdf 24 24

25 Questions 25

26 <Insert Picture Here> E2B (R3): Topics for Consideration 26

27 For Consideration NCA Reporting in the EMA Region The NCA (local authority) will no longer report to the MAH (you) The MAH must pull this information from the Eudravigilance system Method is changing from a push to a pull Does reconciliation need to occur? 27

28 For Consideration IDMP (M5) Doesn t E2B (R3) require IDMP? Yes, but E2B (R3) can live without IDMP due to HL7 message standards that allow text values. 28

29 For Consideration EMA Member States-Specific Specific Requirements May require submission for all nonserious, suspected adverse reports in their territory 90-day compliance period from aware date 29

30 For Consideration HL7 Batch Wrapper Realities HL7 allows a single message (ICSR) to be sent to multiple receivers Similar to one message, multiple addresses in to line Systematically nice, one message to maintain and generate In practice, possibly problematic Consider local formats Single message will contain all local required data as well 30

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