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E2B (R3)E2B (R3): Some Background and What You Should Know and Do Now to Preparep
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 anycontract. 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 anyThe development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.
3© 2012 Oracle Corporation – Proprietary and Confidential
Bio
Will Gordon is currently involved in analyzing the coming E2B (R3) and associated IDMP regulatory changes WillE2B (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 P ti t S f t ki H l l tt d FDA dPatient Safety working group. He regularly 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 yearsproduct development strategy and analysis for eight years.
© 2012 Oracle Corporation – Proprietary and Confidential4
Topics
<Insert Picture Here>• E2B (R3) —Driving to a Better Standard• The Making of the New E2B (R3) Standard• Standard Development Timelines
E2B (R3) I l t ti Ti li K P i t• E2B (R3) Implementation Timeline – Key Points• E2B Backwards and Forwards Compatibility (BFC)• Software Versions that Will Support E2B (R3)• Software Versions that Will Support E2B (R3)• E2B (R3): Topics for Consideration
5© 2012 Oracle Corporation – Proprietary and Confidential
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 li d d l i th t E2B t d d• ICH realized developing the next E2B standard 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• EU (by extension EMA) requires standards to be ISO or CEN
• There is a recognized need for interoperability and robustness
© 2012 Oracle Corporation – Proprietary and Confidential6
The Making of an ISO Standard
C itt D ft • Internal to ISOCommittee Draft
Draft International Standard • Public – technical and editoriala t te at o a Sta da d
(DIS)
Final Draft International
and editorial comments
• Public – editorial Final Draft International Standard (FDIS) comments only
International Standard • Publication
© 2012 Oracle Corporation – Proprietary and Confidential7
ISO ICSR Timeline
2009 2010 2011 2012Jan Apr Jul Oct Jan Apr Jul Oct Jan
1st DIS Ballot (Not Approved)
2nd DIS Ballot (Approved)
FDIS Ballot
ISO Standard!!!
FDIS Ballot Closed
(Awarded Dec. 2011)
8© 2012 Oracle Corporation – Proprietary and Confidential
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
The Making of an ICH Standard
Consensus BuildingStep Consensus Building
Confirmation of Six-Party Consensus
p1
Step 2
Regulatory Consultation and DiscussionStep 3
Adoption of an ICH Harmonized Tripartite Guideline
Step 4
ImplementationStep 5
© 2012 Oracle Corporation – Proprietary and Confidential9
Source: ich.org/about/process-of-harmonisation/formalproc.html
ICH ICSR Timeline
2010 2011 2012Jan Jun Jan Apr Jul Oct Jan Apr Jul Oct
R3 Draft Implementation Guide Released
Start of Consultation
R3 Final Draft Implementation Guide Released
Start of Consultation
Six-Month Consultation Period
ich org/products/electronic standards htmlStep 4Adoption/Sign-Off(Anticipated Nov. 2012)
ich.org/products/electronic-standards.htmlestri.ich.org/new-icsr/index.htm
10© 2012 Oracle Corporation – Proprietary and Confidential
Source: Timeline estimates based on ICH.
10
E2B (R3) Implementation Timeline Key Pointsy
• 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 guidanceauthorities 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 regionalCompliance periods will be identified by regional authorities
• Assumption is ~18 to 24 months implementation per region•• Compliance with EMA Compliance with EMA anticipated sometime in early 2016anticipated sometime in early 2016
11© 2012 Oracle Corporation – Proprietary and Confidential
E2B (R3) Implementation TimelineTimelines Presented Last Year in Toronto
2011 2012 2013Jul 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 EarlyComply (By Mid- to Early 2015)
12© 2012 Oracle Corporation – Proprietary and Confidential
Estimates ONLY.
12
E2B (R3) Implementation TimelineAssumed Implementation Timeline
2012 2013 2014 2015 2016Jan Jun Jan Jun Jan Jun Jan Jun Jan
ISO Standard!!!Completed Dec. 2011
ICH Step 4 Adoption/Sign-Off of ISO Standard(Targeted 4Q 2012)
ICH Step 5 (Implementation)EMA Guidance Released(possibly 2Q 2014, likely later in 2014)
~18-24 months to comply (by early 2016)
EMA Guidance Released(Possibly 2Q 2014, likely later in 2014)
~18 to24 months to comply (by Early 2016)(by early 2016)Early 2016)
13© 2012 Oracle Corporation – Proprietary and Confidential
Future dates are estimates ONLY.
13
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• 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• Additional data to collect/enter into the case report• Backwards and forwards compatibility (BFC) with agencies and
trading/marketing partners
© 2012 Oracle Corporation – Proprietary and Confidential14
Agency Implementation of E2B (R3)
• EMA• Likely the first to implement the new E2B (R3) HL7 message
after IS and ICH adoption is granted
• FDAFDA• Unknown (discussions occurring internally)—More to come late Nov. 2012
• 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© 2012 Oracle Corporation – Proprietary and Confidential
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E2B (R3): Backwards and Forwards Compatibility (BFC)Compatibility (BFC)
16© 2012 Oracle Corporation – Proprietary and Confidential
What Is BFC?
• BFC: Backwards and Forwards Compatibilityy• The ability to receive E2B files in either format and
convert to the other format for transmission or processingprocessing.
R2R2 R3R3BFC
R3R3 R2R2BFC
© 2012 Oracle Corporation – Proprietary and Confidential17
E2B Backwards and Forwards Compatibility (BFC)Compatibility (BFC)
• As mentioned, EMA is likely to adopt R3 firsty• Others following at unknown times
• Both E2B (R2) and E2B (R3) messages will be circulating simultaneously for two to five years maybecirculating simultaneously for two to five years, maybe more
• Backwards and forwards compatibility documentation is p ybeing provided by ICH• The mapping logic for BFC is contained in XSL style sheets• Use of these ICH defined style sheets will make implementation• 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
until the light bulb turns on or the penny drops
© 2012 Oracle Corporation – Proprietary and Confidential
BFC Possible Lifetime
EMA
BFC Need from Implementation in First Region Until Final Implementation
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
EMA
Year 1 Year 2 Year 3 Year 4Year 1 Year 2 Year 3 Year 4FDA
Year 1 Year 2 Year 3PMDA
BFC
PMDA
PossibleNeed
19© 2012 Oracle Corporation – Proprietary and Confidential19
BFC Scenarios
• Ability to accept R2 files and R3 files by same system○ Receipt of an R2 case from marketing partner○ Receipt of an R2 case from marketing partner
• Both R2 and R3 format needed for same case based on destination
© 2012 Oracle Corporation – Proprietary and Confidential20
Note: Scenarios assume company system is R3-capable.
Oracle Support Policy
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Software Versions that Will Support E2B (R3)
21© 2012 Oracle Corporation – Proprietary and Confidential
Empirica Trace Support Lifetime by Version
2012 2013 2014 2015 2016Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan
EMA Guidance Released*3Q 2014
EMA Compliance*Early 2016
4.1Jun. 2012
4.2Jun. 2013 4 34.3
Apr. 2016
22© 2012 Oracle Corporation – Proprietary and Confidential
*Estimated.oracle.com/us/support/library/lifetime-support-applications-069216.pdf
22
Oracle AERS Support Lifetime by Version
2012 2013 2014 2015 2016Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan
EMA Compliance*Early 2016
EMA Guidance Released*3Q 2014
4.6.1Feb. 2012
4.7Jan. 2015Sustaining Supportg pp
23© 2012 Oracle Corporation – Proprietary and Confidential
*Estimated.oracle.com/us/support/library/lifetime-support-applications-069216.pdf
23
Argus Safety Lifetime Support by Version
2012 2013 2014 2015 2016Dec Jan Jun Jan Jun Jan Jun Jan Jun Jan
4 2
EMA Guidance Released*3Q 2014
EMA Compliance*Early 2016
4.2.xDec. 2010Support Was Extended to Dec. 2011
5.0.x Dec 2011Dec. 2011
6.0.x May 2015
7 0 x7.0.x May 2016
24© 2012 Oracle Corporation – Proprietary and Confidential
*Estimated.oracle.com/us/support/library/lifetime-support-applications-069216.pdf
24
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E2B (R3): Topics for Consideration
26© 2012 Oracle Corporation – Proprietary and Confidential
For ConsiderationNCA Reporting in the EMA RegionNCA 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• The MAH must pull this information from the Eudravigilance system• Method is changing from a “push” to a “pull”• Does reconciliation need to occur?
© 2012 Oracle Corporation – Proprietary and Confidential27
For ConsiderationIDMP (M5)
• Doesn’t E2B (R3) require IDMP?
IDMP (M5)
( )• Yes, but E2B (R3) can live without IDMP due to HL7
message standards that allow text values.
© 2012 Oracle Corporation – Proprietary and Confidential28
For ConsiderationEMA Member States-Specific RequirementsEMA Member States Specific Requirements
• May require submission for all all nonseriousnonserious,,ysuspected adverse reports in their territory• 90-day compliance period from aware date
© 2012 Oracle Corporation – Proprietary and Confidential29
For ConsiderationHL7 Batch Wrapper RealitiesHL7 Batch Wrapper Realities
• HL7 allows a single message (ICSR) to be sent to g g ( )multiple receivers• Similar to e-mail—one message, multiple e-mail addresses in
“to” lineto 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 wellSingle message will contain all local required data as well
© 2012 Oracle Corporation – Proprietary and Confidential30