Does Serialization Compliance Equal Brand Protection?

WEBINAR

24 January, 2017

DOES SERIALIZATION COMPLIANCE

EQUAL BRAND PROTECTION?

4

What serialization is…… and isn’t

How serialization does not necessarily

equate to comprehensive brand protection

How the package itself is such an integral

component to brand protection

1

2

3

How mobile authentication can be enabled for

better brand protection

This webinar is intended to be

interactive

Information contained in this webinar is current as

of January 2017

Reserve your seat for upcoming webinars at

www.SystechOne.com/Webinars

We value your feedback!

BEFORE WE DIVE IN…

WEBINAR SERIES

JIM SINISGALLIDIRECTOR, PRODUCT MANAGEMENT

FOR SYSTECH INTERNATIONAL

Jim Sinisgalli is Director of Product Management – Brand Protection. He presently

leads and guides Systech’s anti-counterfeit and authentication business to develop

strategies which protect brands from counterfeiting, diversion and other illicit trade. He

is responsible for developing and executing Systech’s authentication strategy working

with leaders across products and services, and sales. Jim has over an over twenty

year career as visionary leader with half of his career spent protecting customer’s most

precious assets from data to physical product.

PRESENTER

SERIALIZATION DOESN’T

NECESSARILY EQUAL BRAND

PROTECTION

SERIALIZATION IS COMPLIANCE

Which one is

authentic?

LET’S TALK ABOUT WHAT

SERIALIZATION IS ACTUALLY

DOING

EU BOOKEND MODEL

Pharmaceutical

Manufacturer andParallel Distributor

Wholesaler Distributors Pharmacist Patient

Risk-based

verification by Wholesale

distributors

National System 1 - n

Product #

BatchExpiry

S/N

European

Hub

Verification

upon dispense to

Patient

Upload Data

THE PEDIGREE MODEL

Track & Trace captures data at

each step in the supply chain

across partner boundaries

Data captured and saved at each step

Manufacturer Packaging Wholesale distributors Dispenser

ESSENTIALLY AN AUDIT TRAIL IS COLLECTED AND STORED

WHERE IS THE VALIDATION?

DOES THE EU FMD OR THE DSCSA STOP FALSIFIED MEDICINE?

EU FMD

• Only applies to prescription medications

• Does include Anti-Tampering requirement

• Which counterfeiters can mimic

• The first product that is scanned and verified “wins”

DSCSA

• Doesn't even require verification or authentication

• Applies similarly to other global serialization laws

NO, NEITHER THE EU FMD OR THE DSCSA STOP FALSIFIED MEDICINE

SERIALIZATION = COMPLIANCE

THE PACKAGE AS AN INTEGRAL

COMPONENT OF BRAND

PROTECTION

CORE ELEMENTS OF ANTI-COUNTERFEITING STRATEGY

• Tamper-evident packaging or tamper-resistant closures for

all medicines

• A unique serial number for each medicine pack

• Use of overt, covert or forensic authentication features,

but consider:

• Impact to current production

• Cost

• Training requirements

• Degree of accuracy

• Requires material, equipment or processes

• Authentication turn-around time

• Degree of vulnerability of being defeated by counterfeiters

ANTI-COUNTERFEITING PACKAGING STRATEGIES AVAILABLE

Overt Technologies

Authenticated with Visual Inspection

Covert Technologies

Authenticated with Technology

Holograms Security Seals

Colour Shifting Inks Watermarks

RFID Optical

Chemical Microtaggants

SYSTECH UNISECURE™

Non-AdditiveLeverage existing

packaging

CovertCounterfeiters cannot

see to replicate

SecureCannot be reverse

engineered

MobileSmartphone enabled, trusted engagement

BarcodesSerialized and/or non-

serialized

GlobalEnables authenticated

traceability

Systech derives a

unique identification

signature from an

existing bar code

THE HEART OF UNISECURE

Vibrations Manufacturing tolerances

Humidity Consumable variance

UNIQUE FACTORS

Printing is dynamic – there are small-

scale variations in every print mark

Line speed

The result is a unique signature or UniSignature™ “individualizing” each and every item.

UniSecure takes advantage of these

microscopic variations to generate an

inherent, covert security feature

DATA CARRIERS

MOBILIZE AUTHENTICATION

▪ Authentication capabilities for

inspectors, consumers and third parties

▪ BYOA (Bring Your Own Application) –

UniScan will easily integrate into any

mobile application

▪ UniSecure’s Software Development Kit

enables BYOA for iOS and Android

MAXIMIZE YOUR INVESTMENT IN SERIALIZAION

Create trusted uniqueness for each and every

package

• Expand usage of regulatory compliance data

mark

• Enables serialization to become a covert

authentication layer

• Transforms serialized data mark into an authentic

and unique data mark

This is the authentic one!

A REAL-LIFE DISCUSSION ON

HOW UNISECURE PROTECTS

BEYOND SERIALIZATION

21

A UNISECURE FIELD PILOT

POINT OF PACKAGING FOR

PHARMACEUTICAL PRODUCTS

POINT OF DISPENSATION FOR

PHARMACEUTICAL PRODUCTS

SOFTWARE SOLUTION PROVIDER

/ SIMULATED DISTRIBUTOR

PILOT PROCESS

Batch 1: ESM model scanning serialized

numbers at the supply chain end-points (production and

dispensation)

Batch 2: Pedigree model (DSCSA) scanning

serialized numbers at each point in the supply chain

(production, storage, wholesaler, dispensation)

Batch 3: UniSecure solution capturing original print mark for instant authentication at

any point of the supply chain

3 Batches - Each batch contained:

500 cartons - 450 “genuine”

products and 50 “counterfeit”

PILOT PROCESS

Batch 1: ESM model scanning serialized numbers

at the supply chain end-points (production and

dispensation)



Batches 1 & 3 were then shipped

directly to St James’s Hospital in

Ireland

PILOT PROCESS

Batch 2 was further split into 2

separate parts, simulating

distribution to multiple locations

Batch 2: Pedigree model (DSCSA)

scanning serialized numbers at

each point in the supply chain

(production, storage, wholesaler,

dispensation)

Batch 2a: Pedigree model 250 items Batch 2b: Pedigree model 250 items

PILOT RESULTS

Batch 1: ESM model scanning serialized numbers

at the supply chain end-points (production and

dispensation)





Ireland

PILOT RESULTS

Batch 1: ESM model scanning

serialized numbers at the supply

chain end-points (production and

dispensation)



Ireland

36% (18 of the 50) counterfeit products that were randomly added to the

batch were incorrectly verified.

PILOT RESULTS

Batch 2: Pedigree model (DSCSA)

scanning serialized numbers at

each point in the supply chain

(production, storage, wholesaler,

dispensation



Ireland

20% (10 of the 50) counterfeit products that were randomly added to the batch

were verified..

PILOT RESULT

Batch 3: UniSecure solution

capturing original print mark for

instant authentication at any point

of the supply chain



Ireland

100% of the counterfeit products were identified at authentication ensuring

no counterfeit product went to patients

Serialization Compliance Serialization Compliance

Covert Protection

Uniqueness Established

Unique Authentication

Trusted Engagement

MAXIMIZE YOUR INVESTMENT IN SERIALIZATION

CREATE TRUSTED UNIQUENESS FOR EVERY PACKAGE

This is the authentic one!

SYSTECH UNISECURE

SECURECannot be reverse engineered or duplicated

SMARTPHONE ENABLEDPuts authentication into many hands

UNIVERSAL BARCODESWorks for serialized or non-serialized

GLOBAL REACHEnables authenticated traceability

NON ADDITIVELeverage existing package

COVERTCounterfeiters cannot see, as it uses

existing data marks

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WEBINAR

Q&A

JIM SINISGALLIDIRECTOR, PRODUCT MANAGEMENT SYSTECH

Email [email protected]

www.SystechOne.com

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Transcript of Does Serialization Compliance Equal Brand Protection?