minimize the impact of e2b(r3) on drug safety operations with argus safety

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 PROFILEFounded in 1997

Public, NASDAQ: PRFT

2014 revenue $456.7 million

Major market locations:

Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga,

Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax,

Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis,

New York City, Northern California, Oxford (UK), Southern California,

St. Louis, Toronto

Global delivery centers in China and India

>2,600 colleagues

Dedicated solution practices

~90% repeat business rate

Alliance partnerships with major technology vendors

Multiple vendor/industry technology and growth awards

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OUR SOLUTIONS PORTFOLIOBusiness Process

Management

Customer Relationship Management

Enterprise Performance Management

Enterprise Information Solutions

Enterprise Resource Planning

Experience Design

Portal / Collaboration

Content Management

Information Management

Mobile

Safety / PV

Clinical Data Management

Electronic Data Capture

Medical Coding

Data Warehousing

Data Analytics

Clinical Trial Management

Precision Medicine

Consulting

Implementation

Integration

Migration

Upgrade

Managed Services

Private Cloud Hosting

Validation

Study Setup

Project Management

Application Development

Software Licensing

Application Support

Staff Augmentation

Training

BU

SIN

ES

S S

OL

UT

ION

S

SE

RV

ICE

S

CL

INIC

AL / H

EA

LT

HC

AR

E IT

50

+ P

AR

TN

ER

S

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SAFETY / PHARMACOVIGILANCE SERVICES

Implementation

Manage implementations and upgrades

of off-the-shelf and custom drug safety,

pharmacovigilance, signal management,

and medical coding systems

Integration

Build interfaces between safety and

clinical systems

Training

Develop and/or deliver standard and

custom training classes and materials

Process Guidance

Provide insight, advice, and solutions

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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• 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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• 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

DescriptionE2B(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 menstruationperiod date (patient)

B.1.6CCYYMMCCYYMMDD

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



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



Safety ReportVersion 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)


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 CodeMonth

{cyclical} WeekDay {as necessary} Hour

{total} Minute

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KEY CHANGES: DRUG CHARACTERIZATION



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



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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FOLLOW US ONLINE• Perficient.com/SocialMedia

• Facebook.com/Perficient

• Twitter.com/Perficient_LS

• Blogs.perficient.com/LifeSciences

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

http://www2.perficient.com/webinar/Interactive-Business-Intelligence-for-Big-Data-in-Life-Sciences

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THANK YOU

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