EUR OPEAN MEDICINE S A GENC Y MAL TA BID · 2017-10-23 · relocation of the Agency from where it...

EUROPEAN MEDICINES AGENCYMALTA BID


THE EUROPEAN MEDICINES AGENCY IN MALTA

FOREWORD

1

Foreword

Without doubt, the European Medicines Agency(EMA) has a chequered history at the forefront inprotecting and promoting public health in Europethrough the evaluation and supervision ofmedicines for human and veterinary use.

This year marks an important decision on therelocation of the Agency from where it cancontinue to consolidate its base and strengthen itsremit to the benefit of EU citizens.

Malta is prepared to host such an esteemedAgency. It can indeed be an ideal candidatethrough the provision of purpose-built state-of-the-art premises for EMA’s specialised needs thusleading to minimal disruption in its currentoperations. Apart from excellent physicalinfrastructure and excellent quality of life, Malta hasa highly trained and flexible multilingual workforcewhich is conducive to research and innovation.

We will be providing all the necessary assistance inthe relocation process. Personalised relocationsupport is offered including thorough considerationto housing and schooling for all employees andtheir dependents. These can also benefit fromworld-class free healthcare and education.

My Government embraces the opportunity to act asa hub for the pharmaceutical industry and iscommitted to an open and forward-looking visionconcerning the protection of public health. Wepledge the necessary resources to ensure that theseare harnessed to facilitate the current and futureneeds of such an evolving industry. We arecommitted to support EMA in its remit to ensurethat European citizens continue to have access tomedicines of the highest quality, safety and efficacyin line with EU health policy.

Joseph MuscatPrime Minister of Malta


2

The European Medicines Agency(EMA) is responsible for the scientificevaluation, supervision and safetymonitoring of medicines. A significantcomponent of the EMA is its 900 highcalibre scientific personnel and theover 500 international meetingsorganised every year hosting 36,000distinguished visitors.

This outstanding work for ensuringthe quality, safety and efficacy ofmedicines requires an environmentthat meets the needs of all concerned.Malta has several attributes which canfacilitate the smooth operations of theEuropean Medicines Agency. Theseinclude a highly trained and flexiblemultilingual workforce, an efficientinternational transport network, anexcellent ICT infrastructure, well-

established educational institutions,quality health care and a wide rangeof support services.

Combined with Malta’s climate andculture, these attributes guarantee apleasant working and livingexperience. Malta’s safe socialenvironment enables residents andvisitors alike to come together easilyto share experiences and learn fromeach other.

I believe in the importance ofsustaining the Agency’s prestigiousrole and public trust in fulfilling itspresent responsibilities withexcellence. Malta fully supports theambitious vision of the EMA inexpanding its role in a present daydynamic regulatory environment.Close collaboration within theEuropean medicines regulatorynetwork promotes further trainingopportunities and research anddevelopment in meeting patients’legitimate expectations for access tonew and safe therapeutic options.

Malta invites a seamless relocation toa state-of-the-art building at the heartof the Mediterranean, taking intoconsideration the scientific andtechnical needs as well as theergonomic essentials of the people.I am confident that these premiseswill provide EMA with all thenecessary elements to successfullyfulfil its mission and grow further inthe near future. Malta is presenting this invitation to

host the EMA as a testimony to ourcommitment, performance andreputation in the European Union. Thetranquil environment assists in theenhancement of practicalcooperation in regulatory sciences.The quality of Malta’s characteristicsserves as a key aspect in attractingleading experts and beating apotential brain drain. Malta’sapproachability is extended toprovide support needed as a result ofthe invocation of Article 50 triggeringthe exit of the United Kingdom fromthe European Union. Support couldbe given by:

building an Early Warning andPreparedness Systems for factorsinfluencing access to medicines

providing training and materialfor the enhancement of qualityand harmonisation in the area ofregulatory sciences

strengthening practicalcooperation, disseminating bestpractice and providing technicalsupport

establishing a consultative forumto exchange information andpool knowledge

I will endeavour to ascertain that thepotential movement of the EuropeanMedicines Agency to Malta will be apositive milestone.

Helena Dalli

Minister for Social Dialogue, ConsumerAffairs and Civil Liberties

FOREWORD

3

The European Medicines Agency(EMA) is a prime example of theadded value that the European Unioncan bring to Europe’s citizens. Ibelieve that Malta possesses therequisites that will ensure a successfulfuture for medicine regulation atEuropean level. A critical aspect forthe relocation of the EuropeanMedicines Agency is a smooth andseamless transition with minimaldisruption for staff and their families.

Malta provides excellence ineducation, health and general qualityof life including recreational andcultural activity. Maltese spend closeto 90% of their lifespan in goodhealth, longer than in any other EUcountry. Malta has the lowest rates of

preventable mortality in the EU andhas achieved significant improvementin its amenable mortality rates. Theseare the result of a strong public healthframework and accessible, qualityhealth services. These services areavailable free of charge to all EMAemployees and their dependants.

Malta has a long-standing tradition ofhigh standards for education andtraining of health care professionals.The University of Malta has a traditionof spanning several centuries and isthe centre of a scientific, academicand translational medical village. Theareas in close proximity to theUniversity are the main teachinghospitals, the Life Sciences Park and anumber of international institutionsincluding the MediterraneanAcademy of Diplomatic Studies. Theopening of a new overseas medicalschool and nursing school in Maltawill continue to strengthen theprovision of a highly qualified healthcare workforce.

The human resources and physicalfacilities found within the Maltesehealth system are second to none.These resources will be available forthe EMA to tap into. The researchcommunity is rapidly growing. Astrong, internationally recognised,research platform in the area ofgenomics has been developed with aparticular focus on diabetes, cancerand rare diseases. Malta fosters closelinks between the scientific, healthcare and education communities. The

smooth interface between researchcentres, policy makers and clinicalpractitioners enables rapid and agilepolicy response. This creates anenvironment that is well suited to hosta regulatory system that seeks tobalance stringent processes withefficiency, and that is based uponcontinuous learning anddevelopment to take new andevolving needs into account.

The University of Malta has alsoestablished the discipline ofregulatory sciences with the supportof the Ministry for Health. Theseinclude courses at Masters andDoctorate level with internationalacademic participation. These areorganised independently of thepharmaceutical industry andemphasise transparency and ethicaldimensions. The fact that Malta doesnot have a large pharmaceuticalindustry allows it to have a role as aneutral broker and provides a sereneenvironment for EMA to operate.

The Ministry for Health is stronglysupporting Malta’s bid to host theEuropean Medicines Agency. I ampersonally convinced that with Maltaas its new home, the EuropeanMedicines Agency can look forward tothriving and thereby bringing aboutbenefits for patients, industry and theagency’s workers.

Chris Fearne

Minister for Health


4

The Malta Medicines Authority hasaccepted with enthusiasm to lead thebid of the Maltese Government tohost on our islands the EuropeanMedicines Agency (EMA).

It is suggested that aspects of thequality, safety and efficacy ofmedicinal products started in Vallettaat The Holy Infirmary of the KnightsHospitaller of Saint John over fourhundred years ago. The Grand Masterhimself instituted regulationsgoverning the production andacquisition of medicines to ensure theintegrity of products with harshpenalties for any falsified medicines.

The present day movementtranslating pharmaceutical regulatory

affairs into regulatory sciences isspearheaded by the NationalCompetent Authority. We joinedforces with the University of Malta incontributing to education andresearch in the field of health. Oursuccess lies in developing teamworkand advancing in areas of innovation,education, enterprise andemployment. The provision of highlyqualified personnel in the medicinessector is given a priority.

At the Malta Medicines Authority,most of our technical employeespossess post-graduate qualifications.We ventured with the University toappoint trainees at the MedicinesAuthority who are following a level 8doctoral course which is run incollaboration between the Faculty ofMedicine and Surgery at ourUniversity and the University of Illinoisin Chicago making full use of state-of-the-art electronic interactive media.

Scientific personnel of the MaltaMedicines Authority are working ondoctoral research projects in subjectsrelated to regulatory sciencesincluding genomics, biologics,biosimilars, stem cell therapies,innovative medicines, safety signaldetection and rare diseases.

The openness shown by the EMAtowards the effort of middle and lowincome countries in establishing ahigh level regulatory system issupported and endorsed. This was

witnessed recently in Malta throughthe hosting of regulators fromseventeen different African countriestogether with experts from theEuropean Medicines Agencyparticipating to the summit “MakingArticle 58 and other EMA outputsmore relevant for non-EU regulators”.

Malta is well-placed to assist inachieving the objectives of thecommon strategy to 2020 adopted bythe EMA and the Heads of MedicinesAgencies (HMA) through ensuringtimely access to new medicines,focusing on priorities such as bacterialresistance and reinforcing theexcellence of the EU regulation modelby consolidating active participationin the work of the EU regulatorynetwork.

The Malta Medicines Authority ishonoured to provide personalisedsupport for a seamless transition fromLondon to Malta through a dedicatedoffice.

Malta has established itself as a hubfor the pharmaceutical and lifesciences sectors in Europe. Theisland’s unique legal framework,strategic location, solid incentives,highly skilled bilingual workforce andindependence of the regulator aresome of the key success factors whichhelped Malta reach the presentattractive status to host the EuropeanMedicines Agency.

Anthony Serracino Inglott

ChairmanMalta Medicines Authority

FOREWORD

5


6

Relocation of theEuropean MedicinesAgency in Malta: Proposalby the MalteseGovernment

The Government of Malta is offering a bespoke state-of-the

art premises which will be tailored for the European

Medicines Agency. The new building will provide the

European Medicines Agency with an environment that

responds to their present and future projections. The

specifications will include advanced technology catering for

the organisation's operations and efficiencies. It will offer

superior ergonomic and aesthetic space and infrastructure,

commensurate to the status of a world-class organisation.

The Maltese Government is cognisant that such a project

entails an investment amounting to about 50 million euros,

a building to host over 1,000 employees and 40,000 visitors

per year, with an office area of at least 30,000 square metres.

Quality affordable housing, excellent health services, access

to sport and cultural activities, short distances and an

abundance of sunshine present excellent living conditions

for all EMA staff members and their families.

The Maltese Government will provide the European

Medicines Agency with the same terms and conditions of

application of the EU Protocol on privileges and immunities

as are applicable abroad to the European Commission

Representation, European Asylum Support Office and

European Parliament Office in Malta.

The Government of Malta will also provide full institutional

support for the work of the European Medicines Agency, with

adequate and competitive tax rebates in line with European

norms.

HOSTING THE EUROPEAN MEDICINES AGENCY IN MALTA

7


8

Why Malta?

A pleasant working and living experience which will help

attract high calibre persons that EMA needs to function

effectively.

Full institutional support provided by all Maltese

government entities as a one-stop shop specifically

designed to enable a seamless and hospitable relocation

for today’s EMA staff members

Prime aviation services placing Malta as a strategic hub

for air connections which facilitate networking to

European and international grids.

First class conference and hotel facilities which are

centrally located and within easy and quick reach.

A vast variety of housing to meet different tastes and

needs in urban or countryside location.

A high degree of multilingualism reflected in our

educational system, with a number of schools offering

International and European oriented curricula and

qualifications. English is one of Malta’s two official

languages.

An excellent advanced ICT infrastructure, well-established

institutional quality health care services and a vast range

of support services.

WHY MALTA?

9


10

Profile

VALLETTA

Ir-Rabat (Victoria)

Bormla (Cospicua)

Fgura

L-Isla

Rahal Gdid

Floriana

Marsaskala

Rabat

Il-Mosta

St. Paul's Bay

Birkirkara

Manikata

L-Imtarfa

Marsalforn

Il-Fontana

In-Nadur

Ta' Sannat

Kalkara

Burmarrad

Ghar Lapsi

Malta is situated 1 hour away from Rome. Malta’s

location at the crossroads of the Mediterranean has

given the islands a rich historical heritage that has

resulted in a unique inclusive society.

The country’s unique architecture, language and way

of life are testimony of its intricate past.

Malta joined the European Union in 2004. It became

part of the Schengen Area in 2007 and part of the Euro

Zone in 2008.

Malta’s strategic position with its magnificent Grand

Harbour hosting the capital Valletta on one side and

the Three Cities on the other, has featured in major

historical events.

Malta is definitely a great option to settle down due to

its location in the centre of the Mediterranean Sea.

The Maltese Islands have favourable climate with a

daily average of around 12 hours sunshine in summer

going down to 5 to 6 hours in mid-winter. It’s also hard

to beat 300 days of sunshine in a year. Malta’s

summers are as close to perfection as it gets. There’s

no shortage of sunshine between the months of June

and October.

PROFILE

11

Population 434,403

Area 316km

Official Languages Maltese and English

Currency Euro

Capital City Valletta

Time Zone Central European Time


12

International Connections & Internal Transport

INTERNATIONAL CONNECTIONS & INTERNAL TRANSPORT

13

International Connections

Over the last few decades, Malta’s tourism and financial services

growth has fostered a comprehensive and efficient network of

international transport routes, ensuring good daily air connections

to the majority of EU member states.

The Malta International Airport (MIA) welcomes over four and a

half million passengers annually, and links three continents with

over 90 airports directly to Malta. Airport activity at this level makes

MIA one of the best connected in its class. Since its opening in

1992, the air terminal has received continuous investment in

infrastructure, equipment, personnel and services. Malta’s airport

features two runways and can land any class of commercial

aircraft.

Internal Transport

Owing to the dense road network, with a length of around 2,500

kilometres serving a total area of just 316 square kilometres, all

commercial and rural areas including business, retail and

industrial centres are located within minutes of each other. This

allows commuters to travel with ease from one area to another.

Public transport on the Maltese islands is regulated by Transport

Malta . There is a total of 80 different routes that link the different

localities in Malta to major hubs such as Valletta, Mater Dei

Hospital, the airport and to other destinations. It is efficient and

reasonably priced. Buses are the predominant means of public

transport in Malta. The main bus terminus is in Valletta and most

bus routes start and end in Valletta. The average length of a bus

trip in Malta is 20 minutes, the longest trip takes 50 minutes.


14

FLYING TIME TO MALTA - DIRECT FLIGHTS

15

Flying time to Malta Direct Flights

Athens 1h30

Berlin 2h40

Brussels 2h30

Budapest 1h35

Cyprus 2h30

Dublin 3h30

London 3h05

Luxembourg 2h25

Madrid 2h10

Paris 2h20

Prague 2h15

Rome 1h10

Sofia 1h45

Stockholm 3h40

The Hague 2h45

Vienna 2h00

Vilnius 3h00


16

Forecast Average WeeklyFlights for 2017

FORECAST AVERAGE FLIGHTS FOR 2017

17

Amsterdam 10

Athens 12

Barcelona 2

Bari 3

Belgrade 4

Bergamo 7

Berlin (SXF) 2

Berlin (TXL) 4

Bilund 3

Birmingham 6

Bologna 5

Bordeaux 2

Bournemouth 2

Bristol 5

Brussels 16

Bucharest 2

Budapest 6

Cardiff 1

Catania 22

Cluj 2

Cologne 3

Copenhagen 5

Dubai / Larnaca 7

Dublin 5

Dusseldorf 5

East Midlands 4

Edinburgh 4

Eindhoven 6

Exeter 1

Frankfurt 15

Gdansk 2

Geneva 3

Girona 2

Glasgow (GLA) 2

Glasgow (Prestwick) 1

Hamburg 3

Hannover 1

Helsinki 3

Istanbul 14

Karlsruhe/Baden-Baden 2

Katowice 2

Krakow 2

Leeds (Bradford) 3

Liverpool 2

London (Gatwick) 18

London (Heathrow) 16

London (Luton) 8

London (Stansted) 5

Luxembourg 1

Lyon 2

Madrid 5

Manchester 13

Marseille 4

Milan (Linate) 7

Milan (Malpensa) 2

Moscow (Sheremetyevo) 2

Munich 17

Nantes 1

Naples 2

Newcastle 3

Nuremburg 3

Oslo 1

Palermo 2

Paris (Charles de Gaulle) 7

Paris (Orly) 12

Pisa 3

Poznan 2

Prague 4

Riga 2

Rome (Fiumicino) 18

Sofia 3

Stockholm (Arlanda) 3

Stockholm (Skavska) 3

Stuttgart 1

Toulouse 2

Trapani 3

Treviso 3

Tunis 3

Turin 2

Valencia 2

Vienna 13

Vilnius 2

Warsaw 2

Wroclaw 2

Zurich 11


18

Hotel & ConferenceFacilities

In Malta one may find a vast selection

of hotels, ranging from the larger

internationally-branded resorts to the

small family-run boutique hotels; from

coastal establishments located within

walking distance from the beach to

rustic residences situated inland and

city hotels.

The hotel industry in Malta counts an

annual capacity exceeding 66 million

bedrooms and 40,500 bed places on

a daily bases.

The Conference facilities are spread

all over the Maltese islands and

include 289 conference halls capable

of accommodating over 45,000

delegates. These offer top of the range

conference facilities, including event

organisation and management,

audio-visual equipment and

translation and interpretation services.

HOTEL & CONFERENCE FACILITIES

19


20

RentingProperty in Malta

One can source a property to rent by

going through one of the many real

estate agents in Malta or by searching

online or in the local press. Once you

have found what you are looking for,

you will need to sign a Tenancy

Agreement, which protects both your

interests and those of your new

landlord. This agreement will specify

information such as how bills will be

paid, when and how rent is due, the

date the tenancy began and its

duration, services that are provided by

the landlord, such as a cleaning

services or maintenance, the length of

notice required before termination of

the tenancy, and, when applicable,

good practice rules for the common

areas. The majority of landlords will

require a deposit, which is usually the

equivalent of one month’s rent

upfront and rent will usually also be

paid in advance.

A dedicated office will offer its services

to EMA personnel to find appropriate

logging based on one’s needs and

expectations from a vast variety of

residences available for rent or

purchase.

RENTING PROPERTY IN MALTA

21

Renting Property in Malta

Average rentprice in Malta


22

Sliema, St Julians, Gzira & Valletta (Central)

Size Average

3 bedroom flats (110-130 m2) €1169

2 bedroom flats (80-100 m2) €909


Non-detached houses (110-130 m2) €1553

Detached houses (190-220 m2) €2713

AVERAGE RENT PRICES IN MALTA

23

Average rent prices in Malta

Mellieħa, St Paul’s Bay, Qawra & Bugibba (North)

Size Average

3 bedroom flats (110-130 m2) €775





Vittoriosa, Senglea, Cospicua & Marsaskala (South)

Size Average

3 bedroom flats (110-130 m2) €693






24

EducationSystem

The ethos of education in Malta is that students can realise

their full potential within a well-operated and engaging

educational setting. Education in Malta is based on a fruitful

and rewarding programme with an organised and flexible

outlook which translates to ensure that each student reaches

his or her maximum potential in a smooth and enjoyable

manner.

The curriculum is structured so that it accommodates

students at any stage and welcomes newcomers at any level.

This is a characteristic of Maltese education which focuses on

students and their specific needs ensuring a seamless

educational transition.

There are no fees imposed for all European citizens at all

stages of the education system from child care centres to

tertiary education.

The early years of education are mainly focused on personal,

social and emotional development as well as creative skills

through play and activities. Primary education starts at the

age of 5 years and the areas of learning include English,

Mathematics and Science, while students are also exposed

to other areas including Information Technology, personal

and social education and artistic skills.

The curriculum of secondary education is designed to give a

wide range of study in order to tap and develop each

student’s full potential. The emphasis at this level is to offer a

broad programme which ensures the acquisition of basic

skills as well as preparing all students for further education

through career guidance. During this term students are

prepared for the Matriculation and Secondary Education

Certificate(MATSEC) certification course which opens the

door for entry to the University of Malta and universities

abroad.

EDUCATION SYSTEM

25

School System

St. Edward’s College offers the International Baccalaureate

Diploma Program (IBDP). The IBDP includes three subjects

at higher level and another 3 subjects at standard level. Since

its inception, the international Baccalaureate Diploma

Program at St. Edward’s College has had exceptional scores.

The College’s students have reached an average of 82% when

compared to the international average of 79%

St Edwards’s College has developed its teaching programs

and methodologies to cater for the needs of both Maltese

and International students. This school in fact caters for pre-

primary, primary, secondary and upper-secondary

educational needs (ages 3 – 19) The languages of instruction

in all learning systems is French and Italian as part of the

languages curriculum, in addition to English and Maltese.

The Verdala International School was established specifically

to cater for the needs of Malta’s expatriate community. In fact

the vast majority of pupils in the school are non-Maltese and

all lessons are delivered in the English language. Spanish is

part of the curriculum in addition to English and Maltese.

Students can benefit from a holistic educational syllabus that

is recognized worldwide. The School offers the international

General Certificate of Secondary Education (GCSE) and the

IBDP.

The Verdala International School is a member of the

European Council of International Schools and the

Mediterranean Association of International Schools. It is also

accredited by the Middle States Association of Schools and

colleges in the United States, enabling us to offer a US High

school diploma. In addition, it is also authorised to offer the

International Baccalaureate Diploma program to Grades 11

and 12 and the IGCSE program and testing to Grades 9 and

10.


26

International Schools

There are educational establishments that provide for international education in Malta. These include St. Edwards College, Verdala

International School and St. Martin’s College. They can cater for the following language requirements: French, German, Italian

and Spanish. Arrangements can also be made for support in other languages.

St Martin’s College has developed a European-oriented

education system based on professional research and

extensive experience. The School caters for secondary and

upper secondary needs (ages 10 – 19) while its junior school,

Chiswick House School (ages 6 months – 10 years) provides

kindergarten facilities in addition to a primary level

education. The language of instruction at Chiswick House

School and St Martin’s College is English, with French,

German and Italian forming part of the language curriculum,

in addition to Maltese. The College also runs a bilingual

program in conjunction with the Italian embassy.

In 2007, St Martin’s College inaugurated a modern, new sixth

form in the belief that there was a niche for a high-quality

college offering a pre-university education focused on

intense teaching in small groups. The sixth form is now a

success story, with tailored guidance offered to students who

are encouraged to choose a combination of subjects that

best suits their personal abilities and ambitions. Individual

attention is guaranteed as groups are kept small. While the

majority of students follow the MATSEC certification course

which prepares students for entry to the University of Malta,

as well as enabling them to apply for universities abroad, they

are also allowed to select combinations of subjects

depending on the institution of higher education they might

be hoping to join. St Martin’s college is registered with UCAS,

so that students may apply online to UK universities through

the college.

EDUCATION SYSTEM

27

The University of Malta

The University of Malta is the highest teaching institution in

Malta. It is publicly funded and is open to all those who have

the requisite qualifications. The university has a 400 year old

history and today is comprised of 14 faculties, 19 institutes and

a student population of 11,500, including over 1000

international students from 92 different countries following

full-time or part-time degree and diploma courses. The

university regularly hosts a large number of Erasmus and

other exchange students.

A basic Foundation Studies Course enables international

high school students who have completed their secondary

or high school education overseas but who do not have the

necessary entry requirements to qualify for admission to an

undergraduate degree course at the University of Malta. All

lectures are delivered in English and all examinations, other

than those which form part of language courses are also in

English. The international General Certificate of Secondary

Education (IGCSE) and the International Baccalaureate are

recognised as valid entry requirements into the University of

Malta.

The Malta College of Arts, Science and Technology (MCAST)

Established in 2001, the Malta College of Arts, Science and

Technology (MCAST) is Malta’s leading vocational education

and training institution. Through its six institutes in Malta and

the Gozo Campus, MCAST offers 185 full-time and over 300

part-time vocational courses ranging from certificates to

degrees (MQF Level 1 to Level 6). This enables its students to

be prepared for careers in different sectors of the economy

or for higher education.

MCAST collaborates closely with local industries to ensure

that the knowledge, skills and competencies within its

curricula are appropriate and relevant to a dynamic and

forward-looking economy. This relationship stimulates the

College’s success – its programmes are flexible, relevant and

responsive to the aspirations of their students and the needs

of industries, which are constantly evolving to meet the

challenges of a changing global economy.


28

Tertiary Education

Malta offers extensive possibilities for tertiary education:

EDUCATION SYSTEM

29


30

The International Maritime Law Institute

The IMO International Maritime Law Institute was established

in 1988 through an international agreement between the

International Maritime Organisation, a specialised agency of

the United Nations and the Government of Malta. The

Institute is an international centre for the training of

specialists in maritime law and also contributes to the

development and dissemination of knowledge and expertise

in international maritime law, with special reference to the

international regulations and procedures for safety and

efficiency of shipping and the prevention of marine pollution.

Mediterranean Academy of Diplomatic Studies

The Mediterranean Academy of Diplomatic Studies (MEDAC)

is an institution of higher learning with a unique focus on the

Mediterranean region. It offers Master degrees in Diplomatic

Studies and a Joint Masters Programme with George Mason

University in Conflict Resolution and Mediterranean Security.

DIPLOFOUNDATION

Diplo is a non-profit foundation established by the

governments of Malta and Switzerland. Diplo works to

increase the role of small and developing states and to

improve global governance and international policy

development primarily through online courses.

EDUCATION SYSTEM

31

Life Long Learning

Life Long Learning opportunities are also abundantly

available in Malta. Various courses are offered, covering a

number of areas including; drama, music, art and basic

literacy classes. A night institute for further and higher

education provides further opportunities for adults wishing

to pursue various vocational courses, including IT and

computer practices.

American University of Malta (AUM)

The American University of Malta will be taking its first

students on August 2017. The curricula of the AUM are to be

provided by the DePaul University. The University will be

located in two different campuses, one in Marsascala and

another one in Cospicua.

Barts Medical School and the London School of Dentistry

In the coming months, the Barts Medical School and the

London School of Medicine and Dentistry (Queen Mary

University of London), will open its doors in Gozo. The Malta

programmes have a dedicated teaching building and a

state-of-the-art anatomy centre on the Gozo Campus which

is next to the Gozo General Hospital. Their five-year Medicine

MBBS offers the same curriculum that is taught in the Barts

Medical School in London.


32

Knowledge of languages

The sociolinguistic situation in Malta is one of a diffused

societal bilinguilism, with the presence of the two official

languages, Maltese and English. Given our bilingual national

setting, students can acquire and learn these two languages

to develop their cognitive skill and to be able to make

progress in the subject content. All children have the

oppotunity to develop these two languages.

In Malta in the secondary sector, 85% of the students sit for

the Secondary Education Certificate (SEC) English exam, 45%

sit for the SEC Italian exam, 21% sit for the SEC French exam,

7% sit for the SEC German and 6% sit for the SEC Spanish.

In the EU member states, 51% of secondary general

education students study two or more languages. In Malta,

76% of secondary education students learn Maltese, English

and one or more foreign languages.

KNOWLEDGE OF LANGUAGES

33

Knowledge of languages


34

Lifestyle & Family

Everyday life is relatively affordable compared to most

Western countries. A pint of beer at a small pub can go for as

little as €1.50. Food is also very affordable, with a meal in an

inexpensive restaurant costing around €12. The cost of living

index in Malta is 22% cheaper than that of Milan and 39%

cheaper than that of Paris.

When it comes to violent crime, Malta is an extremely safe

country. According to Eurostat, Malta has only 0.3 violent

crime incidents per 1,000 inhabitants.

Malta is one of the fastest growing Information and

Communications Technology (ICT) markets in Europe. ICT,

e-commerce Media and internet law have evolved rapidly in

Malta over the past years and now constitute an integral part

of the local economy. The Maltese government is focused on

developing Malta into a high income economy and in these

last years, invested heavily in the ICT sector as a platform for

inward investment.

All health care in Malta is free. EU national residents in Malta

are eligible to receive free medical treatment at government

funded hospitals and clinics through the EU system on

coordination of social security benefits in kind. Malta also

ranks amongst the top 6 in the EU for the overall quality of

healthcare. The Government’s health centre system works

side by side with a thriving private sector, with 3 main private

hospitals in Malta which provide a wide range of medical

services.

Private health insurance in Malta is extremely inexpensive.

Where simple in-patient plans go for as low as €90 a year, a

payment of around €350 a year will get you full cover.

Largely due to comprehensive and strict government

regulations, the banking sector in Malta is a healthy and

robust one. There are several major banks, including both

local ones like the Bank of Valletta, and foreign chains like

HSBC Holdings PLC and Banif Financial Group.

Malta is characterised by relatively narrow roads and traffic is

generally forgiving when compared to other EU cities.

Largely because of this, Malta also ranks among the lowest in

the EU in terms of fatal traffic accidents.

The Maltese are some of the nicest and kindest people that

you will ever meet. Especially in smaller towns and villages,

most people are always ready to go out of their way to help

you in any immaginable way. It is very easy to integrate with

local communities.

LIFESTYLE & FAMILY

35

Lifestyle and family


36

The Maltese cuisine is a Mediterranean diet based on fresh seasonal

ingredients, and is one of the healthiest and tastiest in the region.

Maltese food is rustic in character, full of flavour and colour typical of

a central Mediterranean Island. Our food is influenced by Malta's

proximity to Sicily and North Africa but with a special slant all our own.

Traditional food accompanies us through life; a glass of smooth local

wine with friends in a village bar comes with a dish of olives, some

ġbejniet (local sheep's cheeses), zalzett (coriander flavoured Maltese

sausage) with galletti (Maltese crackers) and some bigilla (broad bean

pate) served with Maltese bread and olive oil; or on a cold day hot

pastizzi (savoury ricotta filled pastries) are perfect with wine or coffee.

Summer days at the beach means ħobż biż-żejt, a popular snack

made from a thick slice of crusty Maltese bread, rubbed with juicy, red

tomatoes and topped with mint, a little onion, sheep's cheese and

anchovies all soaked in delicious green olive oil; a taste of sunshine, a

taste of Malta.

Over the past few years, Malta has built a reputation for itself

as the most LGBTIQ friendly state in Europe, mainly through

a number of new laws and policies which have been

implemented to ensure equality and safety for all, regardless

of gender identity or sexual orientation.

The Maltese Constitution clearly ensures the enjoyment of

fundamental rights and freedoms for all, and prohibits

discrimination on the basis of gender identity or sexual

orientation. As of 2014, same-sex civil unions and adoptions

by same sex couples are legal, and to date, government is

working towards introducing marriage equality in Malta. A

year later, Malta introduced a law which made it legally

possible for an individual to change the gender they were

assigned at birth in an easy and efficient manner. Conversion

therapy is also illegal in Malta, and government has recently

introduced an ‘x’ option on identification documents.

Over and above the laws implemented, it is the way LGBTIQ

individuals are treated in day to day life which makes Malta

one of the best places to live in. Most Maltese are welcoming

to all, and the gay community is thriving. There are also a

number of ‘gay-friendly’ pubs, nightclubs, restaurants, hotels

and events which may be easily found.

LIFESTYLE & FAMILY

37


38

Maltese CulturalActivities

Carnival

In Malta, the roots of Carnival can be traced back to the early

1400s, although it was the Knights of the Order of St John

that endowed the national festivities with spectacle and

pageantry. Such a venerable tradition means that much that

is new in today’s Carnival is also – in fact - old. Carnival is all

about diversity and inclusion – and, ultimately, joining in the

fun. Dance competitions, float defilés, swarming streets and

exuberant costumes that are an integral part of Carnival. For

a few days Valletta is in party mode. Streets are transformed,

children everywhere are in fancy dress, gigantic floats push

their way through the crowds. Year after year, Carnival arrives,

changing the mood of the capital. And while much around

us changes, some traditions remain.

Malta World Music Festival

At the centre of the Mediterranean Sea, Malta has always

played an important role as a link between north and south,

east and west of our surroundings. This is precisely what

MWMF celebrates- the beauty of cultural diversity, the

exchange and dialogue of people’s roots and the vitality that

is borne out of such experiences and expressed through the

powerful medium of music. MWMF always seeks to expand

its identity as a festival in the middle of our beautiful seas and

connecting with neighbouring countries and beyond.

MALTESE CULTURAL ACTIVITIES

39

Għanafest

Għanafest is a three day world music festival which takes place

every year in June in the enchanting surroundings of the Argotti

Botanical Gardens in Floriana. The Festival takes its name from the

Maltes folk singing known as “Għana” (pronounced A-na). The

programme includes some of this musical genre which goes well

beyond the local boundaries, converging soundscapes and

cultures that look seemingly disparate but are indeed closer than

one may think.

MALTA INTERNATIONAL ARTS FESTIVAL

Featuring a varied programme of theatre, music, dance and visual

arts and offering a broad range of genres and artistic forms, the

festival is held mainly in open-air venues in Malta’s warm summer

nights. The Festival also includes a number of residencies and

workshops with some of its international guests. Listed by the UK

Sunday Times Travel section on its “Top 10 opera, dance and arts

festivals” taking place across Europe in 2011, the Malta International

Arts Festival has achieved international recognition. The Festival is

a member of the European Festivals Association.

MALTA JAZZ FESTIVAL

Valletta’s magnificent Grand Harbour sets the backdrop to the

Malta Jazz Festival. This event has become a byword for high-

calibre performances which delight jazz aficionados and lay

persons alike. Held in the open-air setting of Ta’ Liesse,

contemporary music comes together with a sense of history for

one of the main annual highlights in Malta’s cultural and artistic

calendar.


40

NOTTE BIANCA

Notte Bianca, Malta’s beloved nightlong arts and

culture festival sees the capital’s streets and

cultural venues come alive thanks to a carefully

designed programme of events offering a variety

of entertainments and experiences.

THREE PALACES FESTIVAL

Music of quality and distinction. The Three

Palaces Festival, now in its youthful fourth

edition, has been building a tremendous

following allowing the world’s greatest artists

and younger generation musicians to come and

celebrate together with us all on Malta during

the festival month of November.

MALTESE CULTURAL ACTIVITIES

41


42

43

THE MALTA MEDICINES AUTHORITY

The Malta Medicines Authority is an independent science

and health oriented public entity based on the values of

quality, innovation, people and integrity. The Authority

regulates medicinal products for human use and

pharmaceutical activities.

The Medicines Authority operates in a proactive environment

to meet the dynamics of scientific development, new

legislation and stakeholder needs. With a track record of

assessing over two hundred and fifty medicinal products as

Reference Member State and a team of competent

inspectors carrying out third country Good Manufacturing

Practice inspections in five countries. Malta has established

itself as a hub for the pharmaceutical and life sciences

sectors in Europe.

Malta’s unique legal framework, strategic location, solid

incentives, highly skilled bilingual workforce and

independence of the regulator are some of the key success

factors which helped Malta reach this prestigious status. A

number of structural reforms aiming at positioning Malta

and the Authority as a centre of excellence have been

implemented. The reforms were based on having the right

people and resources to transform challenges into

opportunities.

The Authority invests approximately 10% of its annual budget

on training, capacity building and development. Over 30%

of its employees are carrying out studies at Masters and

Doctoral level. An international fellowship program is offered

to support individuals undergoing Doctoral studies in an

effort to shape a new generation of pharmaceutical leaders.

In July 2016, the Authority relocated to the Malta Life Sciences

Park, a state-of-the-art building located a couple of metres

away from Malta’s University campus and Malta’s state

hospitals. All of the Authority’s processes are covered

through the ISO 9001 certification and the Authority acts in

tandem with scientific developments to ensure that it is

abreast with latest technologies.

Customer satisfaction and transparent dialogue with

stakeholders are pivotal in ensuring that the Medicines

Authority reaches its objectives. The Authority identifies

improvement actions on a continuous basis to meet

stakeholders’ needs and expectations. Following stakeholder

feedback, the Authority launched a number of initiatives,

amongst which a fast track procedure for authorisation of

certain medicinal products.

The Malta Medicines Authority participates actively in

European and International fora. The Authority works in close

collaboration with the European Medicines Agency and the

European medicines regulatory network. The Malta

Medicines Authority was the first agency to deliver joint

scientific advice with another Member State so as to facilitate

accelerated access to medicines.



44

45

Bilateral meetings with different Heads of Medicines

Agencies are organised on a periodic basis in line with the

Authority’s commitment to be a change driver at European

level. A recent collaboration is that the Medicines Evaluation

Board of the Netherlands started outsourcing part of its

assessment work to the Malta Medicines Authority.

The Authority is active in terms of European Good

Manufacturing Practice (EU GMP) third-country inspections.

The inspections carried out by the Malta Medicines Authority

lead to the potential award of an EU GMP certificate. This

activity facilitates the prospect of more companies importing

medicinal products to Europe embracing the strong

regulatory framework of the European Union.

Patients remain at the heart of the Authority’s work.

Medicines availability is being safeguarded by supporting

stakeholders in increasing access to medicines and

developing opportunities for patient empowerment. The

Authority has established a Medicines Intelligence and

Access Unit to support this objective. The success story of the

Malta Medicines Authority underpins the potential of

developing a reference centre in Malta to foster excellence

and co-operation in the European Medicines regulatory

system.



Malta Medicines AuthoritySir Temi Zammit Buildings,

Malta Life Sciences Park,San Gwann SGN 3000

Malta

Email: [email protected]: +356 2343 9000

www.medicinesauthority.gov.mt

Date post:	28-Jun-2020
Category:	Documents
Upload:	others
View:	0 times
Download:	0 times

EUR OPEAN MEDICINE S A GENC Y MAL TA BID · 2017-10-23 · relocation of the Agency from where it...

Documents