- Oracle · E2B (R3) – Driving to a Better Standard • The ICH used E2B (R2) to start electronic...

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E2B (R3)E2B (R3): Some Background and What You Should Know and Do Now to Preparep

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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.

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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


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


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


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)


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).

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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


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


Source: Timeline estimates based on ICH.

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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


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)


Estimates ONLY.

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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)


Future dates are estimates ONLY.

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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


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



E2B (R3): Backwards and Forwards Compatibility (BFC)Compatibility (BFC)


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


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”

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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


Note: Scenarios assume company system is R3-capable.

Oracle Support Policy


Software Versions that Will Support E2B (R3)


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


*Estimated.oracle.com/us/support/library/lifetime-support-applications-069216.pdf

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Oracle AERS Support Lifetime by Version




4.6.1Feb. 2012

4.7Jan. 2015Sustaining Supportg pp



23

Argus Safety Lifetime Support by Version


4 2



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



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Questions



E2B (R3): Topics for Consideration


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?


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.


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


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


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