healthcare news2 | 2

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Here’s how digitization works!Arvato Healthcare uses online and e-commerce expertise to network the healthcare sector

2 | Table of contents

MORE TOPICS

DigitizationFour questions about digitization for Dr Thorsten Winkelmann . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

InternationalisationBen fatto! Bien joué! ¡Enhorabuena! Closer to the market with STOK! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

New Russian base for healthcare logistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Arvato Healthcare strategy Delivering good patient care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Best practice SSAE 16 and ISAE 3402 reports simplify annual financial statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Customer relationship managementTreating depression effectively: “CaringMe” self-care programme successful in Spain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ITSerialization in medication production – obligating pharmaceutical companies around the world . . . . . . . . . . . . . . . . . . .

Noted – Facts worth knowing about…Serialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Digitization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

MasterControl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Event announcementsOverview of upcoming events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Cover topic

Here’s how digitization works . . . 04Arvato Healthcare uses online and e-commerce expertise to network the healthcare sector

Dear Readers,

Digitization has arrived in the healthcare sector and will

play a decisive role in the company’s future success. For

integrated healthcare solutions, new technologies will

be a key factor when dealing with future challenges. For

this reason, Arvato concerned itself early on with how

digitization influences processes and it continues to

develop innovative solutions based on these insights.

In 2001, the energy company Enron triggered one of the

biggest accounting scandals in U.S. history, resulting in

the SOX guidelines. In the 2016 business year, Arvato

was audited using these guidelines for the first time.

Our clients benefit greatly from this new development

because the report generated from them simplifies

annual financial statements, reduces audit expenses

significantly and thus saves on resources. You can find

more information about this topic and all the others in

this issue of healthcare news.

Happy reading!

Sincerely,

Dr Thorsten Winkelmann

Editorial | 3

Follow us on LinkedIn!

LinkedIn / Arvato SCM Solutions

4 | Digitization

Find out more about the topic of digitization in

the NOTED section (p. 18)

How can digitization create added value and promote client loyalty? How is Arvato developing and

implementing digital services? Arvato invited the German industry association for optical, medical and

mechatronic technologies, “Spectaris”, to our SCM site in Düren for a discussion on this topic on March 23.

Here’s how digitization works!

üren is where Arvato Hightech EMEA is based and is

thus an appropriate site for providing insights into new

technologies. At Arvato, digitization is seen as a forward

strategy: “We were early adopters regarding the transformation from

physical to digital solutions. We learned from earlier digitization

experiences and applied them in other sectors,” explains Dr Thorsten

Winkelmann, president of the Healthcare business unit.

The wide range of digital trends in Arvato’s sales and logistics units

include e-commerce and omnichannel solutions, clouds, connected

cars, virtual reality, driverless transport systems and warehouse

automation.

While Thorsten Winkelmann mentions various examples of digital

cases at Arvato SCM Solutions, Andreas Olpeter, VP of Sales &

Business Development Arvato, addresses the solutions that are

already being implemented or are being set up with clients right now

in the Healthcare business unit. Examples include the “JaLife” health-

care platform, web shops for an innovative blood-sugar-measuring

system and an online shop for the home care sector.

D

E-COMMERCE

OMNICHANNEL

SOLUTIONS

CLOUDS

CONNECTED

CARS

VIRTUAL

REALITY

DRIVERLESS

TRANSPORT

SYSTEMSWAREHOUSE

AUTOMATION

The Düren site

In an area of 75,000 square meters…

…350 employees carry out…

…extensive logistics and fulfilment processes

for the high-tech & entertainment and

consumer goods sectors.

Digitization | 5

6 | Digitization

Four questions about digitization for…

Dr Winkelmann, how does a company go digital

and how important is digitization to companies

today?

Digitization has always been woven into our DNA. Bertelsmann was

already using exciting approaches 20 years ago and it made a start

by using new business models in a variety of sectors, such as the

music industry. In the book business in particular, Bertelsmann has

taken a good path towards digitization. Here at Arvato, we were also

quick to pay attention to the way that digitization influences our

processes, while some of our competitors were still specialising in

topics such as warehousing and transport. The genes for successful

digitization include creativity, the will to succeed as well as decen-

tralised structures and the delegation of responsibility. Arvato, as a

digital company, is always brought in when companies want to do

something new or undergo transformation.

And the importance of digitization just keeps getting greater. For

end customer businesses, an online shop leads to an extremely

positive image and thus also has great influence on retail trade. This

is evident in the current discussion about the death of downtown

business districts. Today, you can already assume there will be a 20%

increase in sales for consumer goods in the e-commerce category.

Digitization is also particularly beneficial in terms of networking –

the key concept here is omnichannel retail. Many of our services

would not even be imaginable without digitization.

So Arvato is a digital company. In which business units do you

use Arvato’s digital expertise?

One example can be found in the Consumer Products business

unit. This unit doesn’t just deal with warehousing and transport for

cosmetics and fashion e-commerce; it mainly deals with designing

web pages that inspire users. The employees there have to consider

how many clicks are ideally required for a customer to complete a

purchase. Using this as a basis, the menus are set up in a targeted

way.

100%

„

In response to the question of whether digitization is a high priority for supply chains, the following responses

were given:

Mobile apps & devices and data

analytics are all extremely important

to the supply chain

39 % Yes

The LogiPharma report entitled “The Supply Chain of the Future” asked 100 influential figures in the pharmaceutical

industry questions about healthcare’s hot topics. Below are the results on the topic of digitization.

Mobile apps & devices will not be used

in the supply chain – data analytics

could be important though

10 % No

Data analytics and an information-

enriched end-to-end supply chain are

important

37 % Yes, somewhat

Digital patients, wearables, smart

packaging, the smart pill, mobile apps

& devices and data analytics will be

impacting the pharma supply chain

imminently (if they are not already

doing so)

14 % Yes, extremely

…Dr Thorsten Winkelmann, president of the Healthcare business unit, was asked by Michael René Weber from

ISS International Business School in Hamburg about the importance of digitization to Arvato and about the digital

trends that will play a role in the company’s future success.

You mentioned that online mail-order companies have a posi-

tive image nowadays. Brands are affected by both emotional and

digital factors. This means that with your solutions, you are cre-

ating fascination and hence an additional effect. How important

is customer experience in this context?

For online shops in particular, consumer experience is the alpha and

the omega. User experience optimisation is a service that we are

already offering our Consumer Products clients. Our next step will

be to offer this to our Healthcare clients as well. We analyse the

conversion rate across the entire consumer journey; that is, from the

search for a product to the purchase. We identify at what points in

the process and for what reasons customers break off the ordering

process – and of course how we can prevent this. This optimisation

is the main economic success factor for electronic mail-order com-

panies. In addition, user experience is decisive for brand creation,

a brand’s image and its reliability. Emotional com-

ponents such as a user-friendly product search, the

availability of products and delivery times have great

potential for positively influencing brand creation.

We are now transferring this expertise and the underlying processes,

such as IT, into the healthcare sector. Currently, we are building a

small team of experts in Hamburg who know their way around

the healthcare market. Employees who have already developed

e-commerce solutions for Arvato in the fashion industry are in

charge of the IT. We are building our clients websites with integrated

web shops, as well as carrying out financial processes and taking

care of sales logistics, including returns. The only way for Arvato to

achieve lasting success is for clients to receive added value from our

solutions. In some areas, however, including the digital networking

of logistics chains, we are just getting started.

The networking of logistics chains still has potential?

Yes. In particular, I am looking here at our core value creation in

logistics – our warehouse work. We are running pilot projects with

virtual reality glasses, pick-by-voice and pick-by-vision systems.

These digital technologies are intended to help the commissioner

find and identify goods more easily. But there is a lot of potential

above and beyond the warehouse. This includes networking with

other logistics service providers, for example with transporters, other

warehouse stages or end clients’ ordering systems. I am convinced

that we can manage inventories even more efficiently. The driving

forces will be the automation of processes and the use of big data

to recognise relationships. This will improve service quality for our

clients.

„

Digitization | 7

“The only way for Arvato to achieve lasting

success is for clients to receive added value

from our solutions.“

Dr Thorsten Winkelmann, president of the Healthcare business unit at

Arvato SCM Solutions.

8 | Internationalisation

ince late 2016, Arvato has been rolling out its STOK solutions

across Europe and has thus been pursuing its strategic focus

on setting up international structures for the healthcare

industry. Initial inventory counts (“Cycle Countings”) have now been

carried out in three other countries for an international medical

technology manufacturer.

These cycle countings began in late March, initially in nine hospitals

in Italy. “Within the first four days we were already able to assess

and inspect the inventory in medical facilities in Milan, Lodi, Pavia

and Turin,” says a delighted Maria Rizzuto, who managed the project.

One week later, the STOK solutions went live in France, initially in

hospitals in Marseille and Avignon. The regions of Toulouse, Lyon

and Paris followed suit later in the month. Inventory inspections

were carried out at a total of 160 hospitals for a medical technology

manufacturer that operates worldwide.

Ben fatto! Bien joué! ¡Enhorabuena!

SCloser to the market with STOK

STOK services already live

Forward stocking location

STOK locations

Availability throughout Europe:

Our STOK services are currently being offered

in the United Kingdom, Ireland, Germany,

Belgium, the Netherlands, France, Austria,

Poland, Italy and Spain.

From left to right: Fabrice Aumaitre, Christophe Cavalier (both Field Data Analysts

at STOK) and Lukas Pache (international KAM at Arvato) at a hospital in Paris.

In mid-April, cycle counting began in Spain as well. “The rollout

was successful,” Joaquin Prados, Sales Director Arvato SCM Spain,

is happy to report. “During the first two days, we inspected about

2,000 items in three hospitals in Málaga.”

Through the use of STOK, Arvato customers now have available a

precise analysis of the actual use of their products as well as recom-

mendations derived from that knowledge regarding the optimisation

of inventory management.

Internationalisation | 9

A

New Russian base for healthcare logistics

Facts about the Yaroslavl service centre

oversee the communication channels and…

SERVICE EMPLOYEES

…handle up to 500 social media and web chat inquiries

6,000 CALLS …take up to 6,000 calls…

…handle up to 500 emails…500 EMAILS

…accept up to 1,500 orders…1,500 ORDERS

500 SOCIAL MEDIA & WEB CHAT INQUIRIES

rvato has now been active in Russia for more than 20 years

and it has become particularly well-known in the fashion,

cosmetics, IT, high-tech and household goods sectors. The

priorities here are e-commerce services and B2B services for interna-

tional companies. Over 1,300 employees work for Arvato in Russia.

The direct-to-patient healthcare business is growing

This summer, the healthcare business will also begin to ship products

from Yaroslavl for a well-known medical technology manufacturer. A

web shop will supply patients with the products they request, which

will be dispatched from Yaroslavl. Arvato will be handling inventory

management, deliveries, return processes, customer service and

value added services such as labelling and repackaging.

Special requirements for the healthcare sector

In May 2016, the dedicated warehouse was specially adapted to

the needs of the healthcare sector. Storage conditions are tempe-

rature-controlled at 15–25°C. In addition, the warehouse can be

enlarged in an individualised way based on customer needs.

The Yaroslavl site

This location also has its own supplementary service centre that

offers full, flexible CRM service on site. Throughout the year,

employees at this location answer customer inquiries 24 hours a

day, conduct telephone surveys and handle complaints. Arvato uses

various communication channels for these tasks, ranging from tra-

ditional communication modes such as telephone and fax, mail and

of course e-mail, right through to SMS, a special web chat service

and social media channels – there is a wide range of contact options.

“In addition to central warehouses, regional warehouses in Europe are

also necessary in order to distribute time-critical products or meet

country-specific regulations,” explains Christian Wolf, Executive Vice

President of Arvato Healthcare. Arvato Russia is linked to the central

organisational structure for Europe – with uniform systems for IT

and quality management.

In order to meet international clients’ growing demand for comprehensive, integrated logistics networks in Europe

and thus to guarantee continuous transparent supply chain solutions, Arvato is further expanding its Europe

network at its Russian site in Yaroslavl. Healthcare warehouses were opened in Italy, Spain and the Netherlands

back in 2016 and in summer 2017, our Russian site in Yaroslavl will accommodate its first healthcare client.

10 | Arvato Healthcare strategy

1

Delivering good patient careFrom market demands to strategic priorities

1. Creating international structures

Pharmaceutical and medical equipment companies are taking an

increasingly international approach to organising their distribution

logistics. The EMEA region is often viewed as one area. These

structural changes are often associated with outsourcing or, increa-

singly, with the use of an international service provider rather than

a local one. In order to be able to offer its clients Europe-wide

and networked logistics solutions, one of Arvato’s main strategic

priorities is the development and networking of regional warehouse

structures that are centrally managed, with a uniform IT and quality

management system. The strategy is already being implemented. In

2016 alone, new healthcare sites were opened in Italy, Spain and the

Netherlands; the Russian site in Yaroslavl will follow in summer 2017.

2. Field Inventory Management

Many medical technology manufacturers have long relied on a

central warehouse for the EMEA region. Various supplementary

concepts are used in order to guarantee immediate availability in

hospitals, including consignment warehouses at hospitals, implant

kits and forward stocking locations. Arvato’s STOK Services offer

precisely these services. The services are being rolled out across

Europe, starting in the United Kingdom, where the STOK company,

which Arvato acquired in 2014, was founded. Following the work in

the United Kingdom, Germany, Austria and the Benelux countries,

since spring 2017, STOK employees have also been counting inven-

tory, investigating deviations and optimising inventory management

in Spain, France and Italy.

3. Closer to patients with Arvato

Patient empowerment has been an important trend in the healthcare

sector for quite a while now. With increasing digitization, patient

needs are becoming the linchpin for all healthcare stakeholders.

Pharmaceutical and medical technology manufacturers thus face

the challenge of communicating directly with patients and supplying

them with products and services.

The healthcare market is constantly changing. In particular, digital transformation and increasing internationali-

sation are influencing business. Arvato sees itself as a partner for its clients, providing them with support

in shaping these market changes – and the ultimate goal is always to provide good patient care. Therefore,

“delivering good patient care” is the overarching strategic goal. Three strategic priorities support this goal:

CREATING INTERNATIONAL

STRUCTURES

Establishing and networking regional ware-

housing structures that have uniform and

centrally controlled systems for IT and

quality management

Delivering good patient care

2 FIELD INVENTORY

MANAGEMENT

Europe-wide expansion of the STOK

inventory management services, in and on

the way to hospital

3 CLOSER TO PATIENTS

WITH ARVATO

Patient needs are of pivotal importance

AIM OF THE STRATEGIC

MEASURES

Arvato Healthcare strategy | 11

“By precisely defining and communica-

ting Arvato’s strategic orientation on the

healthcare market, we are demonstrating

why we are pursuing certain objectives

and how we can reach them together.

For us, it is important to show each and

every employee that their daily activities

make an important contribution to this –

whether in the warehouse, in customer

service or in project management,” says

Christian Wolf, Executive Vice President of the Healthcare

business unit at Arvato SCM Solutions.

With this in mind, Arvato will be prioritising the expansion of its

direct-to-patient business. In doing so, knowledge and experience

from other consumer-oriented sectors such as beauty and fashion

will benefit the healthcare industry. Services in this area include the

set-up and UX-optimised operation of web shops, order processing,

client care, warehouse maintenance, the delivery process, risk-opti-

mised payment and accounts receivable management.

A lot has happened at Arvato over the past

year:

For example, the strategy has been revised and it now

places a fresh emphasis on the Healthcare business unit

being an essential driver of growth for Arvato. Using clear

market trends as a basis, this business unit has defined its

growth levers and the corresponding strategic priorities.

12 | Best practice

he Sarbanes-Oxley Act (SOX) is a federal U.S. law that

was passed in 2002 as a reaction to accounting scandals.

Its goal is to generate valid and reliable reporting within

the U.S. capital market. The newfound transparency of companies’

financial data is chiefly intended to help investors regain trust in the

published data.

SSAE 16 and ISAE 3402: Standards for uniform documentation

In order to guarantee that adherence to all measures required by

SOX is also uniformly documented in each company, there is the

U.S. SSAE 16 standard, the “Statement on Standards for Attestation

Engagements No. 16” and the international ISAE 3402 standard, the

“International Standards for Assurance Engagements.”

T

SSAE 16 and ISAE 3402 reports simplify annual financial statementsFor the 2016 business year, the client processes at Arvato’s Harsewinkel site were centrally audited by

PricewaterhouseCoopers (PwC) on the basis of the SOX guidelines for the first time. This simplifies annual

reporting for companies with outsourced services and significantly reduces audit expenses. Even in this,

the first year, it was already possible for the auditing needs of some Healthcare customers, some of which

are client-specific, to be integrated into the report, which they could then obtain from Arvato.

Authors Ruling

Best practice | 13

the representation of the service organisation’s

internal controls is complete and whether the

internal controls are designed accordingly and

implemented appropriately throughout the entire

audit period.

the internal controls throughout the entire audit

period were designed in such a way that the con-

trol objectives were met appropriately at all times.

the internal controls throughout the entire audit

period were effective and supported the control

objectives.

The Sarbanes-Oxley Act, SOX for short, is named

after its authors, the Chair of the Committee on

Banking, Housing and Urban Affairs of the United

States Senate, Paul Sarbanes, and the Chair of the

Committee on Financial Services United States

House of Representatives, Michael Oxley.

It was passed in 2002 as a reaction to one of the

U.S.’s biggest accounting scandals, triggered by on-

going accounting fraud by the Enron energy company.

Following this scandal, the legal requirements for

corporate reporting were drastically sharpened by

means of SOX and other provisions.

For the first time, the Harsewinkel Healthcare site has now received

this report centrally for the 2016 business year (more precisely: the

SSAE 16 SOC 1 Type 2 and ISAE 3402 Type 2 report), audited by

the PricewaterhouseCoopers (PwC) business consultancy. From now

on, the audit will be repeated twice a year, in June and in December.

In the final report, an external auditing company assesses the design

and operational effectiveness of the internal control system (ICS);

that is, it determines whether

As a result Arvato will now be able to make a report available to its

clients every six months and can thus respond flexibly to the parti-

cular time at which a company files its annual financial statements.

Reducing workload and costs

This centralised SOX auditing involves advantages for all parties.

Instead of sending out their own external auditing entities to check

Arvato’s processes, clients can use the SSAE 16/ISAE 3402 report,

which is made available by Arvato. This reduces audit-associated

expenses and use of resources for both sides, for example because

pharmaceutical and medical technology manufacturers no longer

need to be on site themselves during the auditing process. Finally,

using the report simplifies all annual financial statements for clients

and saves costs.

“In the first year, we were already able to seamlessly integrate eight

clients and their individual inspection requirements. Our many years

of SOX experience made it easy to manage the necessary changes

to our processes for the first report,” states Kristina Bernhörster, the

Arvato project manager responsible for this area.

14 | Customer relationship management

A condition with a variety of symptoms

hen a person suffers from depression, the emotional

and cognitive as well as the physical symptoms can

often have a negative impact on all aspects of every-

day life. The causes may be genetic, biological or psychosocial in

nature, and the progression of the condition may be mild, moderate

or severe. In Spain, depression is already one of the most common

reasons for patients booking an initial appointment with a doctor.

Patients with depression need treatment, regardless of the severity

of their condition. Experts agree that treatment should ideally

consist of a combination of different forms of therapy.

Based on these insights, Arvato and the Hospital de Badalona (in

Barcelona) developed the “CaringMe” self-care programme, which

aims to support the treatment of depression by using various

channels.

Treating depression effectively: “CaringMe” self-care programme successful in SpainBy combining an online platform with a telemedical service, “CaringMe” provides supportive treatment for

depression and has now yielded initial positive results. Patients and doctors have also responded positively to

the programme, which Arvato developed together with “Badalona Serveis Assistencials” (BSA).

Average age: 44 years

21.3 % maleAverage age:42.6 years

164 individuals

78.7 % femaleAverage age:44.4 years

Composition of the sample group

A range of channels for greater patient satisfaction

How can therapy be designed more efficiently? How can

resource utilisation in the healthcare sector be optimised and

what increases patient satisfaction? With these primary goals

in mind, the programme is based on two pillars. There is an

online platform, which provides patients and their friends

and relatives with information about the condition. At the

same time, the website allows the medical team to monitor

a patient’s treatment progress and support the patient – in

addition to providing activities and exercises. Moreover,

patients can access a full telemedical service, which is available

via telephone, IM or email. The total duration of the “CaringMe”

treatment is intended to be one year.

A closer look at the programme: The structure of the study

Over a one-year period, the programme was tested for efficacy

with regard to clinical and economic aspects. The subjects

fulfilled certain criteria, such as being of legal age and attesting

to a particular degree of depression. A total of 164 individuals

with an average age of 44 years were included in the study;

more than three quarters of them were female.

Study results: Positive!

Both the clinical and the economic results were very positive.

For example, there was a clear improvement in the values

that measure the severity of the depression and the direct

treatment costs were reduced by half. In addition, patients

and doctors were generally very satisfied with the programme,

which was one of the primary objectives of CaringMe. 8.7 out

of 10 subjects would recommend Caring Me to a relative or

acquaintance.

W

Customer relationship management | 15

“The WHO (World Health Organisation)

estimates that up to 350 million people

around the world are affected and that by

2030 depression will be the main reason for

incapacity for work.”

Source: German Federal Ministry of Health

ECONOMIC RESULTS

The results

***BDI (Beck Depression Inventory) is a psychological test process that records the clinical severity of depressive symptoms. The questionnaire includes

21 questions about how the patient felt in the last week. According to the BDI, values of between 11 and 17 indicate a “mild to moderate degree of

depressive symptoms”. Values of 18 points and over would be a “clinically relevant” result.

51.1 % Cost savings of 51.1 % on direct treatment costs

65.9 % Reduction of 65.9 % in treatment costs for the initial treatment

97.1 % Decrease in productivity loss (e.g. from missed work time due to illness)

72.8 % Reduction of 72.8 % in treatment costs for further/specialised care (e.g. in hospital)

Cost savings outside of the healthcare sector:

**PHQ9 is the depression module of the patient health questionnaire. This questionnaire consists of nine questions and is used for the routine diagnosis of

depression. A PHQ value of 5–9 points suggests “mild depressive symptoms”, while 10–14 points would be considered “moderate depressive symptoms”.

CLINICAL RESULTS

The average PHQ-9 value** saw an improvement of 5.7 points+ 5.7 points

8.1 points: Improvement on the initial BDI***+ 8.1 points

Improvement in therapy adherence to medical treatment to 89 %89.0 %

Improvement in the degree of anhedonia (inability to feel joy and pleasure)anhedonia

16 | Customer relationship management

More information is available on the Spanish

website: http://www.caring-me.com

The Arvato coach contacts

the patient

After the initial conversation,

regular contact is maintained

between coach and patient

via various communication

channels

The patient receives his or her

login data and information about

CaringMe

LOGIN

How does “CaringMe” work?

A Spanish online platform with a telemedical service to provide

supportive treatment for depression via the following channels:

Arvato and the BSA medical

team develop the programme

together and determine its

content

The doctor uses inclusion

criteria to check which

patients are candidates for the

programme and recommends it

to appropriate individuals

The patient signs the consent

form for participation in the

programme

1. Programme development 2. Patient recommendation

5. Initial contact 6. Regular contact

3. Participation consent

4. Receiving login data

The patient’s health and quality of life improve

7. Messbarer Erfolg

Bitte übersetzen

Find out more about the symposium in the

Events section (p. 19)

IT | 17

Directive against falsification

ith Directive 2011/62/EU, the European Union has set

in motion its initiative against medication falsification.

As of February 9, 2019, prescription medicines may

only be sold within Europe if each individual package bears an

individual safety mark in the form of a data-matrix code. Similar

initiatives are being advanced around the world. By 2020, most

countries will have finished implementing serialization.

Serialization process for medication safety

On the basis of the Pharmazentralnummer (German pharmaceutical

identification code), a data-matrix code is generated that includes

an individual serial number and that makes each package unique.

Pharmaceutical companies file the relevant data in a manufactu-

rer database. From then on, the medication’s authenticity can be

checked at all points along the supply chain. Before the medicine is

provided to the patient in the pharmacy, the serial number is read

off to ensure that the medicinal product is valid for distribution.

End-to-end verification has been achieved in the pharmaceutical

field.

A challenge for pharmaceutical companies

Serialization occurs at the intersection of the systems that are

involved. These include ERP software, production and packaging

machines and the systems of external service providers such as prin-

ting presses, as well as the respective national verification systems.

Pharmaceutical producers, contract manufacturers and marketing

authorisation holders thus face great challenges, due in part to the

limited time period for implementation.

WIT solution: Arvato CSDB

“Arvato CSDB” (Corporate Serialization Database) brings together

all the steps of serialization. Internal systems for exchanging data are

connected, serial numbers are generated and managed. The database

also creates intersections with production lines and connects clients,

suppliers of components and production sites to one another. The IT

solution enables relevant data to be reported to the corresponding

national verification systems and relevant reports are made available.

Pharmaceutical companies such as Grünenthal, Ursapharm and

Aenova already use Arvato’s comprehensive IT solution to serialise

their medication packages.

National verification systems

Arvato also supports national verification systems. EU member

countries as well as non-EU-members can use a countrywide IT

system, which is a national blueprint service that facilitates an end-

to-end process within the pharmaceutical distribution and supply

chain.

You can find more information about our IT solutions at

www.IT.arvato.com/serialization

We will be providing information about current topics that relate

to serialization in medication production at the well-established

Serialization Symposium on December 12 and 13 in Berlin.

Serialization in medication production Obligating pharmaceutical companies around the world

In recent years, the pharmaceutical market has increasingly become the target of global medication

fraud. Both generics and high-priced products are affected. In 2015, customs investigators confiscated

about 3.9 million counterfeited tablets – almost four times as many as in the previous year.* In order to

counter this development, more and more countries around the world are working on legal provisions to

prevent falsified medicines from penetrating the legal supply chain. In the healthcare segment, Arvato

Systems covers the entire process chain end-to-end with its own serialization solutions. These solutions

support both individual pharmaceutical producers and national verification systems.

Source: German Central Customs Authority

18 | Facts

…average time savings of 80% when updating lists, revising

documents and sending documents for approval.26 % somewhat prepared

59 % very well prepared

15 % not particularly prepared

100 %

How prepared is your company for the global serialization

requirements imposed by the EU falsification directive?

…MasterControl

Just under one year ago, Arvato implemented the MasterControl

electronic system across its Healthcare business, with the intent of

improving the efficiency of all quality management processes. We

have now seen the first positive results:

…digitization

As part of the Health-i Initiative, a survey of 60 German opinion

leaders was carried out by the Techniker Krankenkasse (health insu-

rance fund) and the Handelsblatt daily newspaper. It came to the

following conclusions:

…serialization

The LogiPharma report entitled “The Supply Chain of the

Future” asked 100 influential figures in the pharmaceutical

industry questions about healthcare’s hot topics. Here are the

results for the topic of serialization:

Patients are the winners in the digitization of the healthcare

sector, said 83 % of those surveyed.*

FACTS – worth knowing about…

+ 80 %

60 % (avg.)

+ 70 %

- 20 %

that on average, employees spend 20 % of their working hours

looking for information that already exists within the company.

What do you think about digitization?…spending 78 % less time updating training records, finding

gaps in training, preparing reports and ensuring that training is

accomplished.

…average time savings of 60 % when preparing forms, copying

and updating form data as well as ensuring that the processes

are not interrupted.

73 % of those surveyed believe that the healthcare sector,

unlike other sectors, has so far achieved very little in the area

of digitization.*

All of those surveyed agree that the digitization of healthcare

offers opportunities for society.*

78 % (avg.)

73 % so far achieved very little

83 % Patients are the winners

100 % opportunities for society

*Source: Health-i initiative: E-health in Germany. Opportunities, challenges, risks

Industry surveys show…

Clients reported…

Clients report time savings of 70 % due to the option of

easily filing documents in MasterControl and finding those

documents quickly.

Learn about the latest topics relating to serialization in medication production. This

year’s Serialization Symposium is again taking place in Bertelsmann’s Berlin offices

at Unter den Linden 1. Take advantage of the opportunity to register in advance

to participate in this free event: www.IT.arvato.com/serialization-symposium.

LogiMed Europe 2017

October 18–19,

Ramada Hotel Hamburg City Centre, Hamburg

Arvato will once again be represented at LogiMed Europe this year, which is

taking place in Hamburg this time. Visit us at the Ramada Hotel and learn about

our integrated logistics and distribution solutions for the medical equipment

industry. Andreas Olpeter and his team will present current business cases to

you and will be happy to advise you about how Arvato can also provide your

company with ongoing support as you continue to grow.

Serialization Symposium 2017

December 12–13,

Bertelsmann Offices, Berlin

Events | 19

12– 13DEC

18– 19OCT

EVENTS

www.healthcare.arvato.com

Arvato Healthcare

Yaroslavl

Blonie (Warsaw)

Berlin

Halle (Saale)

Harsewinkel

Calcinate

Niederbipp

Troyes

Chanteloup-en-Brie (Paris)

Barcelona

Alcalá

Madrid

Jaén

Hamburg

Bad Laer

Gennep

Zaventem (Brussels)

Vendin-le-Vieil

Hams Hall (Birmingham)

Evesham

We believe that healthcare systems, sales channels and

distribution chains undergo constant change to ensure patients

derive the greatest benefit from innovative and existing

pharmaceuticals and medical products at the most reasonable

costs. We support you in making this happen.

Arvato integrates healthcare knowhow, economies of scale and

a broad understanding of processes and IT systems to develop

bespoke outsourcing solutions.

Our clients benefit from seamlessly integrated order-to-cash

solutions which connect them to the point of care, thus

ultimately supporting their patients.

GERMANY & EUROPE SCM

Andreas Olpeter

— +49 5241 80-83099

— andreas.olpeter@bertelsmann.de

GERMANY CRM

Dr Jens Härtel

— +49 5241 80-823-57

— jens.haertel@bertelsmann.de

FRANCE | BELGIUM

Jacques Arzano

— +33 6 78 27 95 14

— jacques.arzano@arvato-healthcare.fr

SPAIN

Joaquin Prados

— +34 91 8023762

— joaquin.prados@arvato.ess

ITALY

Luca Perfetto

— +39 392 9386 624

— luca.perfetto@arvato.it

UNITED KINGDOM

Dr Sebastian Verhoeven

— +49 5241 80-88765

— sebastian.verhoeven@bertelsmann.de

POLAND

Emilia Stapor Kowalska

— +48 22 4447606

— emilia.stapor-kowalska@arvato.pl

Publisher: The management of Arvato Healthcare – Arvato distribution GmbH | Gottlieb-Daimler-Straße 1–7 | 33428 Harsewinkel (Germany)

Responsible for content: Dr Thorsten Winkelmann | Editorial: Christina Restemeier | Phone: +49 5241 80-49187 | E-mail: info@arvato-healthcare.com

Production: networker Medienfabrik GmbH | Reprints of this newsletter, even in excerpted form, are permissible only after consultation with the editorial office.

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