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1 The relationship between the Debrecen University and TEVA Pharmaceuticals Ltd. Prepared: by dr. Ildiko Mihok Head of Faculty 2013

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Page 1: Outsourced Faculty of TEVA Pharma

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The relationship between the Debrecen University and TEVA Pharmaceuticals Ltd.

Prepared: by dr. Ildiko Mihok

Head of Faculty 2013

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The relationship between the Debrecen University and TEVA Pharmaceuticals Ltd.

TEVA is a capital-intensive multinational company with a stable financial background and more than 111 years professional experience

It is the world’s largest generic pharmaceutical manufacturing company; its global product portfolio (which includes more than 1000 molecules) is comprehensive, strong and robust

It is directly present in more than 60 countries worldwide

It employs nearly 46,000 people

It has more than 73 sites worldwide where medicinal products and active pharmaceutical ingredients are manufactured

More than 25 R&D centers

Teva’s branded business focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics

TEVA riched 20.3 billion USD in net revenues in 2012

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Debrecen, HUNGARY

Area: 220,000 m² Number of employees:

1675

Sales revenue in 2012: 165 billion HUF

Domestic sales revenue: 10.8 billion HUF

Export sales revenue: 155 billion HUF

Main activities: solid dosage forms &

manufacturing of active pharmaceutical

ingredients; R&D activities

Sajóbábony, HUNGARY

Area: 35,000 m² Number of employees:

60

Main activities: manufacturing of active

pharmaceutical ingredients

Gödöllő, HUNGARY

Area: 200,000 m² Number of employees:

825

Sales revenue in 2012: 23 billion HUF

Domestic sales revenue: 4.2 billion HUF

Export sales revenue: 18.8 billion HUF

Main activities: sterile manufacturing; R&D

activities, wholesale distribution

TEVA in Hungary

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Pharmaceutical Industrial External Faculty

In December 2007 a collaboration agreement on the establishment of a Pharmaceutical Industrial

External Faculty was signed by Dr. Lajos Hegedűs, Director-General, on behalf of TEVA Pharmaceuticals

Ltd., and by Dr. József Pálinkás, Vice-Rector, on behalf of the Debrecen University.

Our pharmaceutical company and the Debrecen University have been working in collaboration for several decades. We are working together successfully in several fields, one of the most important is the issue of recruitment of new professionals.

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Within the framework of this collaboration, the relationship between the University and TEVA has become closer and closer over the years.

The member of students within the Faculty who intend to write their graduation theses at TEVA Pharmaceuticals Ltd. has been increasing exponentially over the years, and we help students’ education in the following fields:

We organize visits to the company for the following students:

Biotechnology students MSc approx: 20 students

Chemist students BSc II. approx: 50 students

Chemist students BSc III. approx: 40 students

Chemical Engineer students BSc II. approx: 80 students

Chemical Engineer students BSc III. approx: 90 students

Bio-engineer students BSc III. approx: 40 students

Pharmaceutical Industrial External Faculty

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During these visits all students can familiarize with TEVA Pharmaceuticals Ltd.

via a company presentation prepared by the HR Management, and then they

can get an insight into the activities of the Fermentation Plant, the

Biotechnological Laboratory, where they can obtain knowledge on practical

chromatographic methods and the processing of fermentation liquid.

The chemists can gain comprehensive

knowledge on the application of

biotechnological procedures in the

pharmaceutical industry, as well as the

extraction of active pharmaceutical

ingredients.

Pharmaceutical Industrial External Faculty

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The chemical engineer students can get an insight into the process of waste-

water cleaning, then they can gain practical experience on the information

heard during the presentations via viewing the Sewage Plant.

They also can hear presentation on „Engineering knowledge in the

pharmaceutical industry”, and then they visit the biotechnological laboratory

and the fermentation plant, where they hear further presentations on the

fermentation and extraction of active pharmaceutical ingredients, thereby

getting an insight into the work performed at our company.

The can also familiarize with the activity of the industrial production of solid

dosage forms.

Pharmaceutical Industrial External Faculty

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The bio-engineer students can hear a presentation on the importance of

biotechnology and fermentation. After a presentation on the Sewage Plant,

they can view the Biotechnological R&D Laboratory, the Sewage Plant, the

Fermentation Pilot - and the Fermentation Plant.

Pharmaceutical Industrial External Faculty

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Pharmaceutical Industrial External Faculty

We give presentations for bio-engineer students in the following fields:

• Good Pharmaceutical Manufacturing Practice;

• Professional Quality Regulation, Requirements in the pharmaceutical

industry I-II.

We organize 2 different semi-annual work courses for Chemist MSc students

in the following fields:

• Quality control and analytical work in pharmaceutical manufacturing,

• Development of active pharmaceutical ingredients.

Students can choose between gainable knowledge of synthetic organic chemistry and of instrumental analytical work.

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TEVA provides an opportunity for summer practice for more and more

university students (approx. 80) over the years.

Currently BSc and MSc chemical engineers (the latter from the Budapest

University of Technology), BSc and MSc chemists as well as bioengineers

(altogether approx. 70 students) are preparing their graduation theses at

TEVA, and several students are also involved in our TEVA Scholarship

Program.

Pharmaceutical Industrial External Faculty

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Pharmaceutical Industrial External Faculty

17 to 20 Teva employees participate in holding lectures and conducting

practical classes

In 2011 – 17 students prepared their BSc or MSc dissertations at Teva

In 2012 – the number of these students was already 31

In 2013 – we expect the total humber of these students will be 50

We took part in the program of the Bioanalytical Summer School:

- Presentation of the bioanalytical laboratory

- Presentation of drug manufacturing (visit to the plants)

Within the External Faculty both the theoretical lectures and the practical

classes are held by Teva employees, so the students can obtain first-hand

information on drug manufacturing.

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Pharmaceutical External Faculty

The establishment of the Pharmaceutical External Faculty announced

on 18 July 2011.

Dr. Miklós Réthelyi (Ministry of National Resources), Prof. Dr. István Fábián, Rector

(University of Debrecen), Prof. Dr. György Paragh, President (University of Debrecen,

Medical and Health Sciences Center), Dr. Lajos Hegedűs, Director-General (TEVA

Pharmaceutical Works Private Ltd., Co.)

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First year 2008. 4 students 4 TEVA sponsored students

Second year 2009. 10 students 6 TEVA sponsored students

Third year 2010. 18 students 4 TEVA sponsored students

Fourth year 2011. 28 students 4 TEVA sponsored students

History:

Before foundation of external faculty

lectures were and are given to pharmacist students from IV. year 2. semester

on „Industrial manufacture of pharmaceutical products”

Pharmaceutical External Faculty

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The lectures are mandatory for students:

Site tours: Dry Plant 1, Dry Plant 3 & Semisolids, Megapack

Industrial production of solid and semisolid dosage forms (2 x 45 minutes)

Process validation (2 x 45 minutes)

Basics of quality assurance in pharmaceutical industry (2 x 45 minutes)

Quality assurance and control in pharmaceutical industy (3 x 45 minutes)

Industrial production of sterile poducts I.- II. (4 x 45 minutes)

Generic Research & Development (2 x 45 minutes)

Process of registration and marketing authorisation of drug products (2 x 45

minutes)

Primer and secunder packaging materials of drug products, Packaging

process (2 x 45 minutes)

Final exam

All lecturers are TEVA employees.

Pharmaceutical External Faculty

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V. year 1. semester

Total headcount: 13 students/2012

Only students (up to max. 25) can participate, who received excellent results at the final exam

Practice duration: 7 occassions / 42 hours

• Production of solid dosage forms:

1.a.: granulation (wet, dry), compression, encapsulation

1.b.: filmcoating, sugar coating, introduction of new production processes (wurster,

compaction, etc.)

• Production and packaging of sterile products:

2.a.: products in small volume

2.b.: products in large volume

• Packaging of drug products (blisters, containers, etc.)

Storage of API, packaging material, final product, follow up of raw materials

• Quality Control, Quality Assurrance:

Introduction of chemical, microbiological laboratories, tests

Introduction of GMP guides

• Introduction of Generic Research & Development, Pharmatechnological Department:

Generic research & development, productions in lab and pilot sizes

Scale-up, process validation, troubleshooting

Pharmaceutical External Faculty

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Further tasks of the Faculty: Professional summer practices (after third year, duration: 2-4 weeks) Supervision of thesis preparations (literary and experimental themes):

2009: 4 thesis

2010: 6 thesis

2011: 4 thesis

2012: 5 thesis

2013: 8 thesis

Practice leaders, supervisors are TEVA employees.

Pharmaceutical External Faculty

In 2012 we advertised an Innovation competition at the University, which was

also supported by our company, and in which any student of the institution

could take part. We sponsored the first 3 place-winners of the competition.

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Collaboration between Teva and University

This collaboration provides the following benefits for both the University and

TEVA:

Numerous former university students find employment at our company, which is due to the fact that students can gain an insight into the work performed at the company as early as during their university years.

It is noteworthy that both theoretical presentations and practices are held by TEVA employees, so students can obtain „first-hand” knowledge on numerous special fields in pharmaceutical industry, such as biotechnological R&D, manufacturing of active pharmaceutical ingredients (primarily fermentation), analytical work and quality control.

Students can also gain practical experience and an insight into „real” full-scale manufacturing of active pharmaceutical ingredients.

The knowledge obtained in this way is incorporated into the system of university theoretical education and laboratory practices.

Upon changes in company demands, we can employ specialists with more readily convertible knowledge in the field of R&D, of active pharmaceutical ingredients and manufacturing.

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