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.

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

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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.

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PERFICIENT PROFILE
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for specific safety/PV issues, based
upon industry best practices

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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.

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AGENDA
• Why the need for change
• Key changes
• Argus Safety 8.x
• Q&A

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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

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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

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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

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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”

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KEY CHANGES: HL7

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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.

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KEY CHANGES: STRUCTURE

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KEY CHANGES: STRUCTURE

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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

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KEY CHANGES: OIDS
N.1.1 Type of Messages in Batch 2.16.840.1.113883.3.989.2.1.1.1
C.1.3 Type of Report 2.16.840.1.113883.3.989.2.1.1.2

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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)

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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

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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.1.10.2.1 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

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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

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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

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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

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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

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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

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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

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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

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ARGUS 8.x
QUICK SHOW & TELL

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QUESTIONS?

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Next up:
February 18, 2016
Interactive Business Intelligence for
Big Data in Life Sciences
http://www2.perficient.com/webinar/Interactive-
Business-Intelligence-for-Big-Data-in-Life-Sciences

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THANK YOU