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Relocation of the European Medicines Agency (EMA) to Poland

Biotech and pharma industry in Poland

Following a successful economic and social transformation over the past 25 years, Poland has become one of the largest economies in the EU. With a population of 38 m people and a healthy, growing economy, Poland has become an attractive market for the pharmaceutical industry, offering stability and a predictable regulatory environment. This has resulted in the country’s strong position in Europe. Poland is currently the largest pharmaceutical market in Central and Eastern Europe and the sixth largest across the continent, one with bright prospects for the coming years. This provides a great opportunity for further pharmaceutical collaboration, Polish companies leveraging scientific and medical exchanges and joining international networks. This makes Poland and its capital city a perfect destination for the relocation of the European Medicines Agency (EMA).

Intellectual potential of the Polish pharmaceutical sector

Young intellectual potential to absorb: approximately 8 000 pharmaceutic science students at 12 universities approximately 2 000 pharmaceutic science graduates per year

Skilled and experienced labour force: over 100 companies manufacturing drugs approximately 22 000 people employed in 2013 and almost 100 000 posts related to the industry Quality Management systems, Good Manufacturing Practice (GMP), biotechnology

Active cooperation with academia and external institutes: Pharma and chemistry faculties of the best Polish universities Pharmaceutical Institute, Institute of Biotechnology and Medicines, National Institute of

Health 22 science and technology parks creating conditions for the effective commercialisation of

R&D works

Clinical trials About 450-500 clinical trials are registered annually in Poland. Every year, 30 to 40 thousand patients take part in such trials. The key of the clinical trials in Poland is the size of the population, effective recruitment of patients and high quality research. Patient recruitment and the quality of medical staff are the main advantages that are most often mentioned in the context of our country. Poland is still the largest market for clinical trials in the region, but both the number of patients participating in the study and the number of centers where trials are conducted indicate significant potential for growth. Poland is perceived as a country with high standards of applied clinical procedures.

Patient safety Poland believes that the promotion of reporting and feedback among patients and their relatives will improve patient safety through the monitoring, analysis and knowledge-sharing of adverse events. For this reason, many social campaigns have been organized in collaboration with numerous stakeholders. The Polish contribution in this regard will bring value to the work of the European Medicines Agency and European healthcare system.

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Communicating safety information as well as transparency to patients and healthcare professionals is one of the main public health responsibilities common to the European Medicines Agency and Poland. It is essential to promote the rational, safe and effective use of medicines—preventing harm from adverse reactions and contributing to the protection of the health of patients and the general public.

Warsaw already meets the criteria for the relocation adopted by the Council

Criterion 1: The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the Union

The attractive premises of the proposed office will be available from December 2018, in time for the

Agency to take up its functions before the Exit date. If Warsaw is chosen, the office premises will include

sufficient space for offices, meeting rooms and off-site archiving. The relocation timetable will be

confirmed in a headquarters agreement concluded with the Agency.

The Agency would be located in the Business Garden buildings, situated in the office center of Warsaw

(Żwirki i Wigury St.), in close proximity to

Warsaw Chopin Airport. 4 buildings provide

overall office space 56 710 sqm. Office

interiors can be managed and arranged

with a high degree of freedom, making it

easy to adapt the rental space to the

requirements of the Agency in order to

provide an adequate number of staff office

rooms (or open space, if preferable),

meeting rooms, space for storage and

other service promises as well as reception

and lobby.

All installations, including air conditioning, ventilation, access control and surveillance will be monitored

by a building management system (BMS) to ensure efficient functioning and effectively optimize

operating expenses.

High-performing telecommunications and data storage networks as well as appropriate physical and IT

security standards would be provided in the building.

As far as data centres are concerned, Poland has a highly developed IT market fully capable of providing

data centres by external providers.

Alternatively, in case the Agency would

prefer a single building, the Warsaw Hub

building will be ready in 4Q 2019. This

building will be situated in one of the most

prestigious areas of the Polish capital and

in the very center of Warsaw (Sienna

St./Towarowa St. Warsaw). With bus and

tram lines and an intersection of two

metro lines in close vicinity, The Warsaw

Hub building provides excellent transport

links which will be appreciated by

employees and visiting business partners.

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The rentable area will be 37 000 sqm across 30 floors.

The financial terms

The financial terms for the use of the premises will be as follows:

Asking rent per sq m per month: 14 EUR

Rent for parking per month: 90 EUR

Service charge per sq m per month: 16 PLN

Minimum lease term: 60 months

It is worth mentioning, that in case of buildings recommended for EMA, developer offers additional

resources for fitting-out building, tailored for EMA needs, ranging from 180 to 500 euro/m2.

Poland pledges to pay 50% of the rent and service charges for 10 years, in accordance with the given

technical specifications.1

Criterion 2: the accessibility of the location

Convenient air connections to European hubs Warsaw offers 2 international airports with over 180 flight destinations to 65 countries around the world. The city's two airports handle around 16 m passengers a year.

Chopin Airport, the main airport, is located about 10 kilometers from the city centre. Chopin Airport is served by five public bus routes, all of them with stops at Warsaw’s key transport roads and biggest hotels. There are two routes connecting the airport with the city centre, and they run daily between c. 4.30 am – 11.00 pm. There is also one night route running daily between 11.15 pm – 04.49 am. Transfer to the location takes approx. 45 minutes. Buses travel on that line almost 120/60 times a day. Chopin Airport is also linked to the city centre by a railway service operating from 6.00 am to 11.00 pm 3 times per hour. The transfer to the location takes approx. 40 minutes. Trains operate on that line almost 54 times a day.

Warsaw Modlin Airport is located around 35 kilometers north-west of the city centre.

There is a carrier (ModlinBus) that offers direct bus connections from Warsaw Modlin Airport (WMI) to Warsaw city centre (Plac Defilad, opposite the entrance to the Palace of Culture and Science) - the transfer takes 40 minutes. Buses travel on that line almost 50 times a day both ways, and the timetable is adapted to departure and arrival schedule. There is also a train running every hour from the city centre (the journey takes approx. 1 h). Warsaw is well-connected with all EU capitals and major cities, to name a few:

1 As set out in the Annex SN 47/17.

The expansion of the Warsaw Chopin Airport (servicing approximately 300 scheduled flights daily

and over 12.8 m passengers in 2016) along with the launching of the Warsaw Modlin Airport in

2012 has consolidated Warsaw’s appeal as an easily accessible city.

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Flight time:

London 2h 25m Berlin 1h 15m Paris 2h 25m Rome 2h 20m Vienna 1h 15 m Dublin 2h 55m Frankfurt 1h 40m Prague 1h 10m Budapest 1h 10m Bucharest 1h 40m Athens 2h 30m Brussels 2h 05m Luxembourg 2h 00m

International:

New York 8h 10m Chicago 9h 50m Los Angeles 12h 20m Toronto 9h 00m Moscow 2h 00m Bejing 9h 10m Dubai 5h 40m Tokyo 10h 35m

Domestic:

Krakow 50m Gdansk 55m Wroclaw 55m

Infrastructure for visitors

80 hotels 24 000 hotel beds 13 000 hotel rooms 11 five-star hotels, 17 four-star hotels

Warsaw has the advantage of having a high number of four- and five-star hotels. The majority represents international hotel chains such as Accor, Best Western, Carlson Rezidor, Hilton, InterContinental, Marriott and Starwood, as well as others from Polish hotel groups. Most of the hotels are located in the city centre and many of them are within walking distance of the proposed EMA site. Every year, Warsaw hosts about 25 000 business events (congresses, conferences, fairs, meetings). The city is an undisputed leader in terms of the number of business and scientific events held in Poland. Of all the Polish cities, Warsaw also has the highest place in the International Congress and Convention Association’s (ICCA) ratings.

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Public transport The agglomeration is well connected by a dense and effective railway transport system and a combination of subways, trams and urban and regional railways.

Over 730 trams Extensive bus network (281 lines) 32 rapid urban railway trains 70 modern subway trains, another 30 planned to be purchased Continued construction of the 2nd metro line (11 new stations) Continued construction of 19 new park-and-ride facilities within The metropolitan area (making for a total of 30 Park & Ride facilities)

Criterion 3: The existence of adequate education facilities for the children of agency staff

Poland will provide access to educational facilities for the children of the staff of the Agency. Warsaw offers a wide range of multilingual, European-oriented schooling facilities ranging from pre-school through primary and secondary education. There is a wide selection of schools offering teaching in foreign languages (e.g. English, French, German and others). A European school or an accredited European school will soon be established in order to provide education for the children of the staff of EU institutions based in Warsaw (in accordance with the provisions of the Frontex Headquarters agreement). The launch of the accreditation procedure is preliminarily scheduled for September 2017. Moreover, Warsaw-based universities offer a vast variety of study programs in English.

Examples of education facilities in Warsaw and its surroundings offering tuition in a foreign language, including those offering international baccalaureate programs.

American School of Warsaw, British International Academy, The British Primary School of Wilanów, The British School, Casa dei Bambini, Ecole Antoine de Saint-Exupery The English Playhouse, International American School, International European School, The International Preschool of Warsaw Language Café Zuzanna Dembowska-Smyk, Lycee Francais de Varsovie, Monnet International School, Willy Brands Schule.

The City of Warsaw offers a wide range of primary and secondary bilingual schools and can help incoming employees find appropriate educational facilities for their children. There are currently 2048 places in 44 public primary schools offering English, French, German or Spanish classes.

According to a recent survey carried out by the City

of Warsaw, 85% of the inhabitants of Warsaw have

positive views about the public transport.

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Higher education environment Warsaw is a leading Polish academic center with the best and largest Polish universities. There are 61 private and 15 public universities in Warsaw, with approximately 240 000 students and 57 000 graduates.

Warsaw public universities also occupy top places in recognized national rankings. It is Warsaw where the best university (Warsaw University), technical college (Warsaw University of Technology) and economy college (Warsaw School of Economics) in the country are based. Warsaw has a long list of recognized non-public graduate schools, which specialize in economics and IT such as Kozminski University or the Polish-Japanese Academy of Information Technology. The potential of Warsaw universities also lies in its modern R&D infrastructure and innovation centers. One of the most modern institutions in Europe, the Center for New Technologies at the University of Warsaw excels in interdisciplinary research in biology, chemistry, physics and IT. Within the framework of the consortium of leading universities and research institutes in Warsaw, the most cutting-edge institute – the Centre for Advanced Materials and Technology in Central and Eastern Europe - was constructed. This state-of-the-art research centre for materials and technologies of the future is open to cooperation with research teams from Poland and abroad. It is worth noting that the two highest ranking Polish universities listed by the Financial Times in its Business School Ranking – Warsaw University and Kozminski University - are both from Warsaw.

Additionally, the top 6 Polish MBA programs are all based in Warsaw and include:

Warsaw School of Economics Canadian Executive MBA (CEMBA)

University of Warsaw emba@uw - Executive MBA

Kozminski University Executive MBA

Warsaw University of Technology Business School Executive MBA Katalyst

Warsaw School of Economics MBA - SGH

Kozminski University Koźmiński MBA

Criterion 4: Appropriate access to the labour market, social security and medical care for both children and spouses

Job prospects for foreign nationals in Warsaw

An expanding powerhouse of social mobility and innovation, Poland offers an open and stable job market that could easily meet the needs of the children and spouses of the Agency’s staff.

Foreign nationals are mostly employed in the Business Services Sector (BSS), the headquarters of multinational corporations, consulting companies or international law firms. BSS employs over 200 000

It is a city where the number of foreign students is growing steadily every year; in 2016,

for instance, it amounted to nearly 17 000. This number constitutes 1/3 of all foreign

students studying in Poland, and in the next couple of years the number is expected to

reach 20 000.

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employees in Poland (40 000 in Warsaw), 15% of whom are foreigners. BSS centers provide IT, HR, Finance & Accounting, Marketing, Legal, Research & Analysis and R&D services in 40 different languages to all parts of the world. Citizens of EU-member states do not need work permits to take up employment in Poland, while most residents of non EU-member countries will require a work permit.2 Over 2700 international companies operated from Warsaw in 2016. The city is home to the largest number of Business Services Centers in Poland (155, incl. 126 foreign centers) with over 35 000 employees. The centers operate worldwide, which makes the knowledge of foreign languages EMA’s staff and families are likely to bring to the job market a highly desirable asset. US companies have the largest share in the employment structure of business services centers in Warsaw; they employ as much as 47% of the sector’s workforce. The majority of the centers analyzed provide services to customers in Germany (68%). Aside from Germany, the United Kingdom and the USA, business services centers most frequently serve customers from Poland, France and Switzerland. Around the business services sector there has been formed a stable ecosystem of relations and cooperation with the commercial real estate industry, recruitment firms, key city administrations, academic centers and innumerable start-ups and micro-businesses. The business services sector has become an important employer on the Polish market, each year creating attractive jobs that are mainly based on employment contracts for highly-qualified personnel. The high level of growth in employment within the industry in recent years has made business services the most rapidly growing industry in Poland. 37 languages are used at business services centers in Poland. 86% of them employ foreigners. IT services, provided by 37% of the employees, have the largest share in the employment structure of the entities in question. Finance and accounting generates 19% of the jobs, with financial services (banking, insurance, investment) at 11%. An important role in the employment structure, with a 10% share, is also played by customer operations. In total, the above four process categories create over ¾ of the jobs in the sector.3 Top employers in the BSS sector: Credit Suisse, Citi International, Goldman Sachs, Royal Bank of Scotland, Moneygram, Schneider Electric, Procter & Gamble, Samsung R&D Institute, BNP Paribas Securities Services, CBRE Outsourcing Center, GE Engineering Center, Dentons, AC Nielsen, Mercer, Accenture Foreign companies with a headquarters or production site in Warsaw (examples): Orange, Bouygues, T-Mobile, Axa, BNP Paribas, Accor Hotels, Prudential, Aviva, Pfizer, Facebook, Google, Uber, Strabag, Coface, Erste Bank, Generali, Henkel, Carrefour, Raiffeisen, Auchan, Aventis, Danone, Credit Agricole, Dalkia, Allianz, Deutsche Bank Major consulting companies: Ernst & Young, Accenture, Deloitte, KPMG, PwC, McKinsey, BCG, Roland Berger, JLL, Colliers, CBRE, Cushman & Wakefield Major international law firms: White & Case, DLA Pipers, Baker & Mackenzie, Dentons, Cameron McKenna, Clifford Chance, Greenberg Traurig, Hogan Lovells, Weil, Gotshal & Manges, Linklaters, Allen & Overy, Gide Loyrette & Nouel, Bird & Bird

2 Source: https://www.internations.org/warsaw-expats 3 Source: Central Economic Information Center, ABSL Business Services Sector in Poland 2016 report

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Labour market for expats The City of Warsaw Labour Office’s support in finding employees:

refund of equipment for the new workplace costs trainings for new employees recruited via Labour Office use of platforms for employers with job advertisements use of bulletin boards located in city council offices to advertise investor's offers grant for the employment of people over 50 years old month internship/stage

Social security

The staff of the Agency would be exempt from any compulsory contribution to the national social security system,. As a result, they wouldn’t be covered by the national social security regulations unless they voluntarily join the national security system. The same provisions would apply to family members unless they are employed in Poland by an employer other than the Agency or receive social security benefits from Poland. Poland recognises the Joint Sickness Insurance Scheme of the European Union.

Medical care

There are more than 1200 medical facilities in Warsaw, including 67 hospitals. Warsaw also offers walk-in centres as well as overnight and holiday healthcare facilities. Access to those facilities is not limited and the medical staff speaks English. Many of them have graduated from English Divisions of Polish medical universities, which has equipped them with fluent communication skills in English. The scope of medical services can be easily checked on the official website of the Polish e-health agency:

https://rpwdl.csioz.gov.pl/RPM/Search

Poland has also introduced provisions on cross border prescription. This means that a prescription issued abroad in the EU Member State is also valid in Poland.

There are medical benefit packages available on a basis of private medical insurance in most of private medical facilities. List of some English speaking private medical centres in Warsaw: Medicover www.medicover.pl/en/ “Medicover Hospital is privately-owned facility in Poland to offer comprehensive healthcare services to patients. The hospital is ISO 9001:2008 certified and accredited by the Minister of Health. If offers comprehensive lab tests and imaging studies, consultations by world-class specialists. The hospital has been awarded various prizes of merit, the most recent being the Best International Hospital 2015 award. “ American Clinic Warsaw www.americanclinic.pl “The American Clinic Warsaw is a place with unique healthcare standards. This means that a patient from every part of the world can feel comfortable as at a local clinic. The staff speaks fluent English, medical documentation is translated to English upon request, and every patient has a dedicated nurse and a Personal Administrative Guardian.”

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Lux Med www.luxmed.pl “LUX MED Group has prepared healthcare packages which will allow you to fulfill the obligations imposed by the labour code and provide your employees with medical care of the highest quality and perfectly tailored to your needs and the current situation of the company.” Damian Medical Center www.damian.pl/individual-medical-care/ Damian Medical Center „offers a vast range of medical care services provided in six medical centres and one hospital” and “employ doctors of all specialities, clinicians with many years' experience gained in leading medical centres in Poland and abroad.”

Criterion 5: Business continuity

In light of the fact that criteria 1-4 are already met, a smooth transition to the new location will be ensured and business continuity guaranteed. In particular, the office premises will be available in time for the Agency to be able to take up its functions at the new location at the withdrawal date. This shall be confirmed in a headquarters agreement with the Agency.

Good career opportunities, the city’s rich cultural heritage, well-developed public transport and housing market, leisure facilities, and high levels of safety are among the key factors contributing enormously to Warsaw’s high quality of life and uniqueness in the region.

High life satisfaction in Warsaw

Source: Report of international surveys public opinion, Lafarge, Warsaw 2014.

There are numerous factors that make Warsaw appealing to foreign nationals, namely:

A deep talent pool as an essential factor in facilitating and encouraging robust economic development

The constant injection of 'fresh blood' is guaranteed by 75 public (University of Warsaw, Warsaw University of Technology, Warsaw School of Economics, Warsaw Medical University) and private (Kozminski and Lazarski Universities, Polish-Japanese Academy of Information Technology) higher education institutions. According to the Financial Times and Perspektywy magazine rankings, Warsaw universities provide the best quality of education in Poland to 250 000 students (including several thousand foreign nationals).

Warsaw is a fast developing bustling metropolis with a high quality of life

28% of green areas in the city 76 city parks 6 public beaches 98 museums 31 cinemas (14 multiscreen)

94% of citizens are happy with the place they live in

81% of those who chose to live in Warsaw feel good in the city and more than half of

inhabitants appreciate the career opportunities Warsaw has to offer

80% of the population has a good opinion regarding public transport

90% are satisfied with the metro services

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44 theaters and 2 operas Numerous outdoor events and concerts with worldwide known artists, incl. famous Chopin music

concerts in Lazienki Royal Park (summer weekends) 100 outdoor gyms Over 3 500 restaurants Over 1 000,000 square meters of commercial shopping area Over 480 kilometers of cycling paths 44 indoor swimming pools Numerous aquaparks, ice rinks and a year-round ski slope Numerous horse stables and golf clubs many other sports available in Warsaw such as rope parks, bungee jumping, bowling, squash,

quads, paintball, go-carts. Copernicus Science Centre, which is Polish the most famous and kid-friendly interactive science

center

Easy communication in English

Warsaw was ranked 10th in the world in the EF English Proficiency Index.

Cost of Living

Comparison with London prices: Consumer prices 49.8% lower Rent prices 73% lower Restaurant prices 60% lower Hotel prices 70% lower

High levels of safety

Warsaw is known as a safe city with an environment conducive to overall life satisfaction for its citizens. According to Barometr Warszawki’s study from 2016, as much as 85% of interviewed residents were reported to hold a positive view Warsaw’s state of security.

Poland has no indigenous terrorism and no known terrorist organizations have been identified to operate in Poland, according to United States Department of State statement about Poland and Warsaw. By all accounts, the city is a safe and appealing place to live and work compared to many other European capitals.

Warsaw ranks 13th out of 111 safest cities in the world in the SafeAround Ranking, and is considered the 6th safest city in Europe. As stated in the ranking: “violent crime almost doesn’t exist in Warsaw which has a low terrorist risk”.

Warsaw also takes 1st place in Poland as the safest city in the “Europolis Safe and Open Cities” 2017 ranking. It surveyed 66 Polish cities, taking into account 44 indicators. The survey was carried out by Polityka Insight Magazine for the Polish Robert Schuman and Konrad Adenauer Foundations.

Residential property market

214 000 of flats have been built in Warsaw between 2003 and 2017, giving an average of 14,000 per year.

Approximately 167 000 flats and houses will be put to use within the boundaries of the City of Warsaw in the years from 2018 to 2030.

According to forecasts, the amount of office space in Warsaw exceeded 5 m square meters, only 3 years after breaking the 4 m square meters barrier.

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Warsaw implemented the Integrated Revitalisation Program of the City of Warsaw, which is expected to run until 2022.

Criterion 6: Geographical spread Relocating EMA to Warsaw, a city at the heart of Central and Eastern Europe, will have the advantage of meeting the geographical spread criterion in accordance with the objective set in December 2003 by the representatives of the EU Member States meeting at the Head of State or Government level in 2008.

Privileges and immunities for the Agency and its staff Protocol No. 7 on privileges and immunities of the European Union will apply to the Agency and its staff members. A headquarters agreement would specify the detailed provisions with regard to the application of the Protocol. An equivalent scope of privileges and immunities4 as those adopted for the staff5 of the European Border and Coast Guard Agency (Frontex), beyond the Protocol’s provisions, would be granted, namely:

Extending to the director and the top management of the Agency the same privileges and immunities as accorded to diplomatic agents accredited in Poland.

The VAT exemptions (up to 20 000 PLN) for purchasing furniture and households articles within 2 years from the establishment the Agency in Poland and for the new employees (employed for a period of 1 year or more);

The VAT and excise exemption for purchasing, in Poland, one motor vehicle per one staff member for personal use, once for every 3 years for the staff employed for a period of 1 year or more.

The Member State’s plan for when and how the relocation should take place and how this plan would ensure that the Agency remains operational: Poland is ready to ensure that relocation will take place in due time, before withdrawal date. All details concerning the relocation process will be agreed upon with parties concerned and at a later stage of the procedure to ensure a smooth transition to the new location. Poland will establish a relocation support team responsible for all practical issues pertaining to EMA relocation activities and responsible for helping EMA employees settle in a new place.

Help for expats There are numerous expat agencies and communities in Warsaw which can help new employees with every needed procedure and provide practical information about living in Warsaw and enjoying it. Moreover, the City of Warsaw can organize free of charge programs for new employees, which will introduce them to the city and facilitate their integration with Warsaw`s residents.

4 The exact details of the complex provisions can be found in art 12 of the Headquarters Agreement between the Republic of Poland and the European Border and Coast Guard Agency (Frontex) signed on 9th March 2017. 5 Polish nationals and permanent residents are excluded from some of the below listed privileges, like in the Headquarters Agreement between the Republic of Poland and the European Border and Coast Guard Agency (Frontex) signed on 9th March 2017.

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The Multicultural Center offers:

Valuable information – addressed to foreigners seeking information about the city, the local government and non-governmental programs addressed to them or cultural offer;

Integration of foreigners to help them enjoy active life in Warsaw and support for expat communities in integration activities;

Education – support for educational activities related to multiculturalism, integration, multicultural education and Polish language courses;

Culture - support for cultural activities carried out by representatives from diverse foreign background, support for international cultural projects and an interactive exhibition on the multicultural heritage of Warsaw.

Expat agencies Express Relocations www.expressrelocations.com VIP-Service www.vip-service.com.pl Katika Expat Assistance www.katika.pl Pol-in www.pol-in.pl/ang/index.html Expat Service www.expatservice.info/index.php Expats Guide www.expatsguide.pl/ Expats community websites www.expat.com www.internations.org/warsaw-expats www.icfwarsaw.pl/about-us/conference-center/ Expat groups on Facebook Foreigners In Warsaw (5 000 members) https://www.facebook.com/foreignersinwarsaw/?fref=ts Expats in Warsaw (7 000 members) https://www.facebook.com/groups/wawexpats/?fref=ts Warsaw EXPATS (8 000 members) https://www.facebook.com/groups/expatsinwarsaw/?fref=ts