Minimize the Impact of E2B(R3) on Drug Safety

Operations with Argus Safety

 ABOUT PERFICIENT
Perficient is the leading digital transformation
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With unparalleled information technology, management consulting,
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value with outstanding digital experience, business optimization,
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PERFICIENT PROFILE
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 OUR SOLUTIONS PORTFOLIO
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 SAFETY / PHARMACOVIGILANCE SERVICES
Implementation Integration

Manage implementations and upgrades Build interfaces between safety and

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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
2019

2017
EMA mandatory reporting
PDMA mandatory - Apr
EMA report downloads from
2016 EudraVigilance (after audit)
Clinical trial reporting (after audit)

EMA pilot Jan-Mar

Clinical trial reporting - interim period
2015 PDMA option to submit from Apr

FDA CBER eVAERS (June)

FDA CDRH eMDR (August)

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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

E2B(R2) E2B(R3)
Description
Field Format Field Format
Date of birth
B.1.2.1 CCYYMMDD D.2.1 At least to the day
(patient)
Last menstruation CCYYMM
B.1.6 D.6 At least to the year
period date (patient) CCYYMMDD
Date of birth
B.1.10.2.1 CCYYMMDD D.10.2.1 At least to the year
(parent)
Last menstrual
B.1.6 CCYYMMDD D.10.3 At least to the year
period date (parent)

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 KEY CHANGES: AGE GROUP

E2B(R2) E2B(R3)
Description
Field Format Field Format

neonate foetus
infant neonate
child infant
Age group B.1.2.3 adolescent C.3.1 child
adult adolescent
elderly adult
elderly

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 KEY CHANGES: DATE OF TRANSMISSION

E2B(R2) E2B(R3)
Description
Field Format Field Format

Safety Report
2AN - -
Version Number

Date of this
A.1.3 CCYYMMDD C.1.2 CCYYMMDDhhmmss
transmission

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 KEY CHANGES: DRUG ADMINISTRATION

E2B(R2) E2B(R3)
Description
Field Format Field Format

Number of units in
B.4.k.5.4 3N G.k.4.r.2 4N
interval
Year UCUM Code
Month
Time interval unit Week {cyclical}
B.4.k.5.5 G.k.4.r.3
Day {as necessary}
Hour
Minute {total}

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 KEY CHANGES: DRUG CHARACTERIZATION

E2B(R2) E2B(R3)
Description
Field Format Field Format

suspect suspect
Characterization of concomitant concomitant
B.4.k.1 G.k.1
drug role interacting interacting
drug not administered

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 KEY CHANGES: AMENDMENTS

E2B(R2) E2B(R3)
Description
Field Format Field Format

Report nullification/ nullification

A.1.13 Yes C.1.11.1
amendment 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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THANK YOU

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