TRACK AND TRACE FOR ANTIBIOTIC API

- TO COMBAT A GLOBAL HEALTH THREAT

RICHARD BERGSTRÖMPHARMA SECTOR LEAD

countries

3000employees

32200+

Sales to

countries

Offices in

SICPA AT A GLANCE

Founded in CH in

1927

50+engineering expertise

Protection of 85+% world currency(more than 140 B banknotes in circulation)and value documents using security inks

Products authentication and tracking (more than 80 B product units are

serialized annually)

CONTINUOUS INVESTMENT IN R&D

ANTIMICROBIAL RESISTANCE

In placeUnder way

Decided: Still to shapeDecision expected

Decided but scope not clear

Non-governmentmore likely

PHARMA SERIALISATION

Europe: Responsibilities of theSupply Chain Partners

Serialization by MAHRisk based verification by WholesalersVerification and check-out at point of dispense

Safety features:Code (‘unique identifier’)

+Tamper evidence

System set up and Governance by MAH together with other stakeholders

Oversight by competent authorities

NMVS

Product #: 09876543210982S/N: 12345AZRQF1234567890Batch: A1C2E3G4I5Expiry: 140531

EU Hub

API TRACK & TRACE: SOLUTION CONCEPT OVERVIEW

API Produced

API container marked with unique API number

through stamp

Stamp activated with scanner

API shipped to producer.Shipment tracked.

DMS • Stamps ordered• Order approval• Stamps delivered• Stamps activated• API numbers

API number stored in DMS after activation

API number sent to MAH to accompany final product

Supply chain subject to EU FMD (under implementation)

API Number

API Number

API Number

API Number

API Number

API Number

API Number

API Manufacturing Stage

Purchasing Office / Norwegian Public Authority have:• Overview of approved API producers;• Overview of orders, API numbers and MAH destination;• Control over approving stamp orders for delivery;• Possibly remote monitoring and geolocation services.

API Control Stage

API production under regular sampling and possibly remote monitoring

Geolocation monitoring

Data SourceOrganisatione.g. hospital, pharma, CRO

Guardtime Network

Guardtime KSI-Blockchain

Data isgenerated

Hashvalue+

Metadata+

Source/Identity

UpstreamCommunic

ation Entry inCalender

Blockchain

KSI Signature

Feedback:KSI

Signature

12 3

4

56

KSI BLOCKCHAIN

Application

Storage of Data +KSI Signature

GUARDTIME KSI-BLOCKCHAIN TO PROVE DATA INTEGRITY AND DATA PROVENANCE

SICPA-GUARDTIME SOLUTIONS FOR THE LIFE SCIENCE INDUSTRY

Patient

DigitalBiomarkers

eHealthRecords

Clinical Trials

Research&Development

MedicalDevices

Drugs

Supply Chain Manufacturing

RegulatoryAuthorities

Life ScienceIndustry

DataData

Data

Data

Data

Data

DataDataDataData

Data

Data

Data

HealthcareProviders

Data Integrity Data Provenance Cybersecurity

Biobanks

TACK!

DANK U WEL

MERCI VIELMAL !

Enabling trust