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European Free Trade Association Flashcards, test questions and answers

Q: Which of the following countries are currently members of the European Free Trade Association (EFTA)?

Norway, Iceland, Liechtenstein, and Switzerland More test answers on https://studyhippo.com/global-91011/

Q: There are two main trading blocs in Europe, the European Union and the European Free Trade Association. TRUE or FALSE

True More test answers on https://studyhippo.com/mgt-302-ch-9/

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We've found 7 European Free Trade Association tests

Business Management European Free Trade Association Free Trade Area International Business Regional Economic Integration

BUS 280 q.9 – Flashcards 90 terms

Kevin Stewart

90 terms

Preview

BUS 280 q.9 – Flashcards

question

The country of Argonia and the country of Berylia imposed tariffs on imports from all countries. They set up a free trade area, removing all trade barriers between themselves but maintaining tariffs on imports from the rest of the world. Argonia now begins to import sugar from Berylia. Previously, Argonia was indigenously producing sugar at a higher cost. Thus, Argonia benefits from this transaction. This is known as _____.

answer

Correct trade creation

question

Which of the following is true of the criteria to qualify for membership to the European Union (EU)?

answer

Correct The applicants were required to tame inflation.

question

_____ occurs when lower-cost external suppliers are replaced by higher-cost suppliers within a free trade area.

answer

Correct Trade diversion

question

Which of the following is true of the Andean Pact of 1969?

answer

Correct Political and economic problems seem to have hindered cooperation among member-countries of the Andean Pact.

question

Which of the following is the goal of the Caribbean Single Market and Economy?

answer

Correct To harmonize macroeconomic and monetary policy between member states

question

A(n) _____ is defined as a central political apparatus that coordinates the economic, social, and foreign policy of the member states.

answer

Correct political union

question

Which of the following is a solution to the issue of how to make a coordinating bureaucracy accountable to the citizens of member nations?

answer

Correct Establishment of a political union

question

The European Community was established with the signing of the _____ in 1957.

answer

Correct Treaty of Rome

question

Which of the following refers to an association of English-speaking Caribbean states that are attempting to establish a customs union?

answer

Correct CARICOM

question

Three countries enter into an agreement to remove all tariffs and trade barriers between them. They decide on a common trade policy with regard to nonmembers. Faced with political backlash, the countries stop short of allowing mobility of factors of production such as labor and capital. Which of the following levels of economic integration best describes this arrangement?

answer

Correct Customs union

question

Which of the following is a reason why Mercosur was temporarily suspended in 2001?

answer

Correct An economic crisis in Argentina

question

Which of the following is a drawback of adopting the euro?

answer

Correct Loss of control over national monetary policy

question

The _____ refers to a trade pact among Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua, which began in the early 1960s but collapsed in 1969 due to war.

answer

Correct Central American Common Market

question

Which of the following is a reason for Great Britain, Denmark, and Sweden to stay out of the euro zone?

answer

Correct The implied loss of national sovereignty to the European Central Bank

question

_____ occurs when high-cost domestic producers are replaced by low-cost producers within a free trade area.

answer

Correct Trade creation

question

Which of the following is true about how the euro will impact the pan-European capital market?

answer

Correct It will increase efficiency with which investment funds are allocated.

question

Which of the following is true about the European Commission?

answer

Correct The European Union's competition commissioner has been gaining influence as the chief regulator of competition policy in the member-nations of the European Union.

question

Which of the following levels of economic integration involves the use of a common currency, harmonization of members' tax rates, and a common monetary and fiscal policy?

answer

Correct Economic union

question

Which of the following entails a closer economic integration and cooperation than a common market?

answer

Correct Economic union

question

Which of the following is an issue confronting the North American Free Trade Agreement?

answer

Correct Expanding the membership of the agreement

question

The _____ is composed of one representative from the government of each member-state, and whose membership depends on the topic being discussed.

answer

Correct European Council

question

Which of the following is true of the Single European Act?

answer

Correct The act provided the impetus for the restructuring of substantial sections of European industry.

question

Which of the following comprises the euro zone?

answer

Correct The 17 member nations who use euro as its currency

question

Which of the following is true of the Asia-Pacific Economic Cooperation (APEC)?

answer

Correct It was founded in 1990 at the suggestion of Australia.

question

An argument against the North American Free Trade Agreement centered on the fear that ratification would result in:

answer

Correct mass exodus of jobs from the United States into Mexico.

question

The European Council considered to be the ultimate controlling authority within the European Union (EU) because:

answer

Correct draft legislation from the European Commission can become EU law only if the council agrees.

question

The _____ is responsible for proposing European Union legislation, implementing it, and monitoring compliance with European Union laws by member states.

answer

Correct European Commission

question

Which of the following is a consequence of the implementation of the North American Free Trade Agreement?

answer

Correct Some U.S. and Canadian firms would move production to Mexico to take advantage of lower labor costs.

question

Which of the following led to the collapse of the Central American Common Market in 1969?

answer

Correct War between Honduras and El Salvador after a riot at a soccer match between teams from the two countries

question

Which of the following is true of regional economic integration?

answer

Correct By creating a single market, the EU aimed to lower the price for goods and services across the bloc.

question

Which of the following is true of the Treaty of Lisbon that was signed in 2007?

answer

Correct It created the position of the president of the European Council.

question

The _____ refers to a 1969 agreement among Bolivia, Chile, Ecuador, Colombia, and Peru to establish a customs union.

answer

Correct Andean Pact

question

In the context of international labor relations, which of the following is a concern of organized labor?

answer

Correct An international business keeps highly skilled tasks in its home country and farms out only low-skilled tasks to foreign plants.

question

Which of the following is an advantage of an ethnocentric staffing policy?

answer

Correct It helps transfer core competencies to a foreign operation.

question

According to the survey undertaken by Towers Perrin, which of the following countries provides the highest pay to HR executives?

answer

Correct The United States

question

In firms following a(n) _____ staffing policy, the lack of managers' mobility among national operations implies that the pay for expatriates should be kept country specific.

answer

Correct polycentric

question

Firms that use an ethnocentric staffing policy consider it to be:

answer

Correct the best way to maintain a unified corporate culture.

question

Which of the following is a disadvantage of adopting a geocentric staffing approach?

answer

Correct Training and relocation costs increase when transferring managers from country to country.

question

A(n) _____ staffing policy seeks the best people for key jobs throughout the organization, regardless of nationality.

answer

Correct geocentric

question

Which of the following staffing policies relies extensively on the use of expatriate managers?

answer

Correct Ethnocentric staffing policy

question

A firm's ability to reduce its use of expatriates may be limited, particularly if it is pursuing a(n) _____ staffing policy.

answer

Correct geocentric

question

Broadly speaking, a(n) _____ staffing approach is compatible with an international strategy.

answer

Correct ethnocentric

question

Which of the following is a major obstacle to the establishment of the Free Trade Area of the Americas?

answer

Correct The United States wants its southern neighbors to agree to tougher enforcement of intellectual property rights, which they do not want to embrace.

question

A(n) _____ has no barriers to trade between member countries, includes a common external trade policy, and allows factors of production to move freely between members.

answer

Correct common market

question

Which of the following is true with regard to establishment of the euro?

answer

Correct It required participating national governments to give up control over monetary policy.

question

Which of the following are the two impediments to regional economic integration?

answer

Correct Costs and national sovereignty

question

Which of the following is true of the euro since its establishment in 1999?

answer

Correct The euro has had a volatile trading history against the U.S. dollar.

question

Which of the following is true of the Andean Pact during the mid-1980s?

answer

Correct The Pact had failed to achieve the objective of a common external tariff.

question

The _____ proposed that all impediments to the formation of a single market be eliminated by December 31, 1992. The result was the Single European Act.

answer

Correct Delors Commission

question

_____ are the most popular form of regional economic integration, accounting for almost 90 percent of regional agreements.

answer

Correct Free trade agreements

question

_____ refers to the pact among Argentina, Brazil, Paraguay, and Uruguay that originated in 1988 to establish a free trade area.

answer

Correct Mercosur

question

Which of the following is the economic level corresponding to the least integration?

answer

Correct A free trade area

question

The _____, which has 754 members as of 2012, is directly elected by the populations of the member-states.

answer

Correct European Parliament

question

The _____ refers to an attempt to establish a free trade area between Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

answer

Correct Association of Southeast Asian Nations

question

_____ occurs when higher-cost external producers are replaced by lower-cost external producers within the free trade area?

answer

Correct Trade creation

question

The agreement of the member-states of the Central American Common Market joined by the Dominican Republic to trade freely with the United States is known as _____.

answer

Correct Central American Free Trade Agreement

question

Which of the following organizations, established in 1951, was the forerunner of the European Union?

answer

Correct European Coal and Steel Community

question

Which of the following is true of the Court of Justice?

answer

Correct It is the supreme appeals court for European Union law.

question

Which of the following is true with regard to an economic union?

answer

Correct It involves the free flow of products and factors of production among member-countries.

question

Which of the following is a feature of a common market?

answer

Correct Allows free movement of factors of production between member nations

question

Which of the following was a change proposed by the Single European Act?

answer

Correct Apply the principle of "mutual recognition" to product standards

question

Which of the following countries has adopted the euro as its currency?

answer

Correct France

question

A(n) _____ is defined as a group of countries committed to removing all barriers to the free flow of goods and services between each other, but pursuing independent external trade policies.

answer

Correct free trade area

question

Which of the following is the aim of the Central America Free Trade Agreement?

answer

Correct Lowering of trade barriers between the United States and the Central American Common Market countries

question

Which of the following is true of the East African Community (EAC)?

answer

Correct Their program includes cooperation on immigration, road and telecommunication networks, investment, and capital markets.

question

Which of the following changes were proposed by the Single European Act?

answer

Correct Open public procurement to nonnational suppliers

question

Which of the following is a benefit of adopting the euro?

answer

Correct The adoption of a common currency makes it easier to compare prices across Europe.

question

A key advantage of adopting the euro is that it:

answer

Correct lowers foreign exchange and hedging costs in Europe.

question

_____ refers to agreements among countries in a geographic region to reduce and ultimately remove tariff and nontariff barriers to the free flow of goods, services, and factors of production between each other.

answer

Correct Regional economic integration

question

The European Community became the European Union in 1993 following the ratification of the _____.

answer

Correct Maastricht Treaty

question

Which of the following is a factor that resulted in the establishment of the European Union (EU)?

answer

Correct The devastation of Western Europe during two world wars and the desire for a lasting peace

question

Which of the following is true of the provisions of the North American Free Trade Agreement?

answer

Correct It seeks the removal of most barriers on the cross-border flow of services.

question

Suppose the country of Ceria and Lithinia imposed tariffs on imports from all countries, and then they set up a free trade area, scrapping all trade barriers between themselves but maintaining tariffs on imports from the rest of the world. Now, Ceria begins to import sugar from Lithinia. However, Ceria had previously been importing sugar from another country, Cadnia, which produced sugar more cheaply than Ceria or Lithinia. This is known as _____.

answer

Correct trade diversion

question

Which of the following principles did the Single European Act propose to apply to product standards?

answer

Correct The principle of "mutual recognition"

question

Which of the following is true regarding the establishment of the euro?

answer

Correct By adopting the euro, the European Union has created the second most widely traded currency in the world after that of the U.S. dollar.

question

Which of the following supports the economic case for regional economic integration?

answer

Correct Coordination and policy harmonization problems are largely a function of the number of countries that seek agreement.

question

The right of foreign truckers to pick up and deliver goods within another member-state's borders is known as _____.

answer

Correct cabotage

question

Which of the following is true of the political case for regional economic integration?

answer

Correct Countries can enhance their political weight in the world by grouping their economies.

question

Which of the following is true about the European Parliament?

answer

Correct It is directly elected by the populations of the member-states.

question

Which of the following institutions has a monopoly in proposing European Union legislation?

answer

Correct European Commission

question

Which of the following is considered to be the ultimate controlling authority within the European Union?

answer

Correct European Council

question

Which of the following is true of Alexander Yeats' criticism of the Andean Pact?

answer

Correct He pointed out that Mercosur countries were insulated from outside competition by tariffs that run as high as 70 percent of value.

question

The _____ refers to a permanent bailout fund, worth about €500 billion, set up by the euro zone nations to restore confidence in the euro.

answer

Correct European Stability Mechanism

question

Which of the following is an example of concerns over national sovereignty acting as an impediment to regional economic integration?

answer

Correct Great Britain refusing to adopt the common currency of the European Union, the euro

question

Which of the following are significant trade blocs in Europe?

answer

Correct The European Union and the European Free Trade Association

question

Concerns about _____ arise because close economic integration demands that countries give up some degree of their control over such key policy issues as monetary policy, fiscal policy, and trade policy.

answer

Correct national sovereignty

question

The movement toward regional economic integration has been most successful in _____.

answer

Correct Europe

question

The Andean Community now operates as a _____.

answer

Correct customs union

question

Which of the following is true with regard to regional economic integration?

answer

Correct Regional economic integration is good for consumers because it lowers prices.

question

Which of the following is true of the theoretically ideal free trade area?

answer

Correct No discriminatory tariffs, quotas, subsidies, or administrative impediments are allowed to distort trade between members.

STUDY

Business Management European Free Trade Association Free Trade Area International Business

IB Chapter 9 – Flashcards 15 terms

Joseph Fraser

15 terms

Preview

IB Chapter 9 – Flashcards

question

A _____ has no barriers to trade among member-countries, includes a common external trade policy, and allows factors of production to move freely among members, but does not have a common currency.

answer

Common market

question

The ultimate controlling authority within European Union is the European Commission.

answer

false

question

Regional economic integration and the consequent increase in increased dependence on each other creates incentives for political cooperation between the neighboring states and reduces the potential for violent conflict.

answer

true

question

Which feature of an economic union differentiates if from a common market?

answer

Harmonization of tax rates of member-countries

question

Collectively, the member-states of the _____ account for about 55 percent of the world's GNP, 49 percent of world trade, and much of the growth in the world economy.

answer

The Asia-Pacific Economic Cooperation

question

Which of the following is an argument against economic integration?

answer

It reduces degree of control over certain issues such as monetary and fiscal policy.

question

In addition to NAFTA, the only other significant trade bloc in the Americas is Free Trade Area of the Americas (FTAA).

answer

true

question

Two countries, Cadmia and Palladia, have formed a free trade agreement. This has resulted in Cadmia importing sugar from Palladia which it previously did from another country at a lower cost. This agreement has led to:

answer

trade diversion.

question

The lowering of barriers to trade and investment among countries has led to decreased price competition throughout the EU and NAFTA.

answer

false

question

Which of the following trade pact collapsed due to a war?

answer

Central American Common Market

question

Free trade agreements are the most popular form of regional economic integration, accounting for almost 90 percent of regional agreements.

answer

true

question

Which of the following is true with regard to NAFTA?

answer

Many observers credit NAFTA with helping to create the background for increased political stability in Mexico.

question

Which treaty committed EC members to adopting a common currency by January 1, 1999?

answer

The Maastricht Treaty

question

Which feature of a customs union differentiates it from a free trade area?

answer

Adoption of a common external trade policy

question

Identify the correct sequence of economic integration starting from the least integrated to the most integrated.

answer

Free trade area, Customs Union, Common Market, Economic Union, and Political Union.

STUDY

Business Law European Free Trade Association Free Trade Area Free Trade Association International Business Mergers And Acquisitions

MGT 302 Ch. 9 – Flashcards 84 terms

Marie Florence

84 terms

Preview

MGT 302 Ch. 9 – Flashcards

question

Regional economic integration involves agreements among countries in a geographic region to reduce, and ultimately remove, tariff and non tariff barriers to the free flow of goods, services, and factors of production between each other. TRUE or FALSE

answer

TRUE

question

The movement toward regional economic integration has been most successful in Asia. TRUE or FALSE

answer

FALSE

question

In a customs union, trade barriers are eliminated among member countries, and each country maintains its own external trade polices with nonmember countries. TRUE or FALSE

answer

FALSE

question

A common market has no barriers to trade between member countries, includes a common external trade policy, and allows factors of production to move freely between members. TRUE or FALSE

answer

TRUE

question

A common market entails even closer economic integration and cooperation than an economic union. TRUE or FALSE

answer

FALSE

question

The European Union is an example of a perfect economic union. TRUE or FALSE

answer

FALSE

question

Coordination and policy harmonization problems are largely a function of the number of countries that seek agreement. TRUE or FALSE

answer

TRUE

question

Linking neighboring countries economically and making them interdependent creates incentives to increase political cooperation as well. TRUE or FALSE

answer

TRUE

question

Because of the fact that everyone benefits from economic integration, it is easy to achieve and sustain. TRUE or FALSE

answer

FALSE

question

A major impediment to economic integration is the loss of sovereignty it entails. TRUE or FALSE

answer

TRUE

question

Trade diversion occurs when higher-cost external producers are replaced by lower-cost external producers within the free trade area. TRUE or FALSE

answer

FALSE

question

In theory, WTO rules should ensure that a free trade agreement results in trade diversion. TRUE or FALSE

answer

FALSE

question

A regional free trade agreement will benefit the world only when the amount of trade it creates exceeds the amount of trade it diverts. TRUE or FALSE

answer

TRUE

question

There are two main trading blocs in Europe, the European Union and the European Free Trade Association. TRUE or FALSE

answer

TRUE

question

The Treaty of Rome, signed in 1957, established the European Free Trade Association. TRUE or FALSE

answer

FALSE

question

A central reason for the establishment of the EU was the devastation of Western Europe during two world wars and the desire for a lasting peace. TRUE or FALSE

answer

TRUE

question

The Council of the European Union is responsible for proposing EU legislation, implementing it, and monitoring compliance with EU laws by member states. TRUE or FALSE

answer

FALSE

question

The ultimate controlling unit within the EU is the European Council. TRUE or FALSE

answer

TRUE

question

The European Parliament is primarily a consultative rather than legislative body. TRUE or FALSE

answer

TRUE

question

The judges of the European Court of Justice are required to act as representatives of national interests, rather than as independent officials. TRUE or FALSE

answer

FALSE

question

The establishment of the euro required participating countries to give up their monetary policy. TRUE or FALSE

answer

TRUE

question

The Single European Act committed EU countries to adopting a common currency by January 1, 1999. TRUE or FALSE

answer

FALSE

question

Establishment of the euro created the largest currency zone in the world, replacing the position the U.S. dollar had held for decades. TRUE or FALSE

answer

FALSE

question

Great Britain, Sweden, and France have led the push toward adopting the euro. TRUE or FALSE

answer

FALSE

question

A key benefit resulting from the adoption of the euro is the ability to compare prices across member markets. TRUE or FALSE

answer

TRUE

question

The implied loss of national sovereignty to the ECB underlies the decision by Great Britain, Denmark, and Sweden to stay out of the euro zone for now. TRUE or FALSE

answer

TRUE

question

Since its establishment, the euro has had a stable trading history. TRUE or FALSE

answer

FALSE

question

On average, studies indicate that NAFTA's overall impact has been small but positive. TRUE or FALSE

answer

TRUE

question

The governments of both Canada and the United States are keen on adding other Latin American countries to NAFTA. TRUE or FALSE

answer

FALSE

question

The Andean Pact is a highly successful common market modeled after the EU. TRUE or FALSE

answer

FALSE

question

According to Alexander Yeats, the trade diversion effects of Mercosur outweigh its trade creation effects. TRUE or FALSE

answer

TRUE

question

The Free Trade Area of the Americas that was established in 2005 has thus far proven to be a success. TRUE or FALSE

answer

FALSE

question

The bulk of intra-ASEAN trade consisted of goods whose tariffs had been reduced through an ASEAN preferential trade arrangement. TRUE or FALSE

answer

TRUE

question

The Asia-Pacific Economic Cooperation was established to increase multinational cooperation in view of the economic rise of the Pacific nations and the growing interdependence within the region. TRUE or FALSE

answer

TRUE

question

Political turmoil in several African nations has persistently impeded any meaningful progress in economic integration. TRUE or FALSE

answer

TRUE

question

The East African Community (EAC) has been a successful integration effort in Africa during the last three decades. TRUE or FALSE

answer

FALSE

question

To exploit the opportunities presented by the EU, non-EU firms must establish EU subsidiaries. TRUE or FALSE

answer

TRUE

question

A benefit to companies of economic integration is the opportunity to centralize their production and reduce costs. TRUE or FALSE

answer

TRUE

question

Once barriers to trade and investment are removed, companies can treat a group of integrated countries like the EU as a single market and produce standardized products for it. TRUE or FALSE

answer

FALSE

question

The emerging role of the European Commission in competition policy suggests the EU is increasingly willing and able to intervene and impose conditions on companies proposing mergers and acquisitions. TRUE or FALSE

answer

TRUE

question

From least integrated to most integrated, the levels of economic integration are: A. a common market, a free trade area, an economic union, a customs union, and a political union. B. a free trade area, a customs union, a common market, an economic union, and a political union. C. a customs union, a free trade area, a common market, a political union, and an economic union. D. a common market, an economic union, a customs union, a free trade area, and a political union.

answer

B. a free trade area, a customs union, a common market, an economic union, and a political union.

question

Which level of economic integration eliminates trade barriers between member countries and adopts a common external trade policy? A. Political union B. Customs union C. Common market D. Economic union

answer

B. Customs union

question

Country X and Country Y reach an agreement to boost bilateral trade. They agree to remove all barriers to the trade of goods and services. They, however, are free to determine their own trade policies with regard to nonmembers. Which level of economic integration is this an example of? A. A customs union B. An economic union C. A common market D. A Free trade area

answer

D. A Free trade area

question

Which feature of a customs union differentiates it from a free trade area? A. Harmonization of members' tax rates B. A common currency C. A common external trade policy toward nonmembers D. Ability of factors of production to move freely between members

answer

C. A common external trade policy toward nonmembers

question

A _____ has no barriers to trade between member countries, includes a common external trade policy, and allows factors of production to move freely between members. A. common market B. customs union C. free trade area D. bonded market

answer

A. common market

question

Three countries agree to remove barriers to trade between member countries and adopt a common external trade policy toward nonmembers. They also agree to allow people and other factors of production to move freely across their borders. Which level of economic integration is this an example of? A. Bonded market B. Customs union C. Free trade area D. Common market

answer

D. Common market

question

Which feature of a common market differentiates it from a customs union? A. Harmonization of members' tax rates B. A common currency C. A common external trade policy toward nonmembers D. Ability of factors of production to move freely between members

answer

D. Ability of factors of production to move freely between members

question

A(n) _____ involves the free flow of products and factors of production between member countries, the adoption of a common external trade policy, a common currency, harmonization of members' tax rates, and a common monetary and fiscal policy. A. economic union B. common market C. customs union D. free trade area

answer

A. economic union

question

Which feature of an economic union differentiates it from a common market? A. Free flow of products and factors of production between member countries B. A common monetary and fiscal policy C. A common external trade policy toward nonmembers D. Ability of factors of production to move freely between members

answer

B. A common monetary and fiscal policy

question

Which of the following is a reason why the European Union is considered an imperfect economic union? A. Factors of production are not allowed to move freely between member countries. B. Not all members of the union have adopted the euro. C. Almost all markets are heavily regulated. D. Products and services are not allowed to move freely between member countries.

answer

B. Not all members of the union have adopted the euro.

question

The move toward economic union raises the issue of how to make a coordinating bureaucracy accountable to the citizens of member nations. Which of the following offers a solution to this problem? A. A common market B. A free trade area C. A customs union D. A political union

answer

D. A political union

question

What is the most enduring free trade area in the world? A. NAFTA B. EFTA C. ASEAN D. Mercosur

answer

B. EFTA

question

Why doesn't Great Britain use the euro as its national currency? A. Would have to convert its economic structure to the euro B. Would have to relinquish control of its monetary policy to the EU C. Would have to change its financial markets operations D. Would have to obtain approval from the U.S. Federal Reserve

answer

B. Would have to relinquish control of its monetary policy to the EU

question

A political benefit of economic integration is that: A. it enables participants to achieve gains from the free flow of trade. B. it enables participants to achieve gains from the free flow of investment. C. it allow countries to specialize in the production of goods and services that they can produce most efficiently. D. it reduces the potential for violent conflict.

answer

D. it reduces the potential for violent conflict.

question

Which of the following explains why economic integration has never been easy to achieve or sustain, despite the strong economic and political arguments in support? A. No country has shown significant improvement because of economic integration. B. Countries fear a reduction of their political weight in the world because of economic integration. C. Linking neighboring economies and making them increasingly dependent on each other creates little incentives for political cooperation. D. While a nation as a whole may benefit significantly, certain groups may lose.

answer

D. While a nation as a whole may benefit significantly, certain groups may lose.

question

_____ occurs when high-cost domestic producers are replaced by low-cost producers within the free trade area. A. Trade deficit B. Trade diversion C. Trade creation D. Trade distortion

answer

C. Trade creation

question

Which of the following occurs when lower-cost external suppliers are replaced by higher-cost suppliers within the free trade area? A. Efficiency gain B. Trade diversion C. Trade deficit D. Trade creation

answer

B. Trade diversion

question

Country A and Country B entered into a free trade agreement recently. After this, Country A starts importing heavy machinery from Country B. Country A used to previously import such machinery at lower rates from another country. Which of the following has occurred in this scenario? A. Trade creation B. Efficiency gain C. Trade deficit D. Trade diversion

answer

D. Trade diversion

question

To ensure that a free trade agreement does not result in trade diversion, which of the following has to come within the scope of WTO? A. Nontariff barriers B. Services C. Energy markets D. Tax rates

answer

A. Nontariff barriers

question

The European Community was established by: A. the Treaty of Rome signed in 1957. B. the Maastricht Treaty signed in 1991. C. the Maastricht Treaty of 1994. D. the Single European Act of 1987.

answer

A. the Treaty of Rome signed in 1957.

question

The _____ is responsible for proposing EU legislation, implementing it, and monitoring compliance with EU laws by member states. A. European Parliament B. European Commission C. Council of the European Union D. Court of Justice

answer

B. European Commission

question

Why is the European Council said to be the ultimate controlling authority within the EU? A. Since it is responsible for implementing EU legislation and monitoring compliance with EU laws by member states B. Since its role in setting competition policy is becoming increasingly important to business C. Since it has the right to vote on the appointment of commissioners D. Since draft legislation from the commission can become EU law only if the council agrees

answer

D. Since draft legislation from the commission can become EU law only if the council agrees

question

Which of the following is directly elected by the populations of the member states and is primarily a consultative rather than legislative body? A. The European Parliament B. The European Commission C. The Council of the European Union D. The Court of Justice

answer

A. The European Parliament

question

Which of the following was the outcome of the Treaty of Lisbon signed in 2007? A. It established the European Community. B. It resulted in the adoption of the Euro. C. It changed the name of the European Community to the European Union. D. It increased the power of the European Parliament.

answer

D. It increased the power of the European Parliament.

question

Which of the following observations pertaining to the EU's Court of Justice is incorrect? A. It is comprised of one judge from each country. B. It is the supreme appeals court for EU law. C. Its judges are required to act as representatives of national interests. D. A member country can bring other members to the court for failing to meet EU treaty obligations.

answer

C. Its judges are required to act as representatives of national interests.

question

Which of the following observations is not true of the euro? A. It is used by all member states of the European Union. B. It required participating countries to give up their own currencies. C. It required participating countries to give up control over monetary policy. D. By adopting it, the EU created the second most widely traded currency in the world.

answer

A. It is used by all member states of the European Union.

question

Which treaty, signed in December 1991, committed EC members to adopting a common currency by January 1, 1999? A. The Maastricht Treaty B. The Treaty of Rome C. The Single European Act D. The Treaty of Lisbon

answer

A. The Maastricht Treaty

question

Which of the following is seen as a benefit of the euro? A. Governments gaining greater control over their monetary policies B. Reduced competition in most industries C. Zero interest expense for businesses D. Lower foreign exchange and hedging costs

answer

D. Lower foreign exchange and hedging costs

question

Which of the following is seen as a disadvantage of the euro? A. Higher foreign exchange and hedging costs B. National authorities losing control over monetary policy C. It becomes difficult to compare prices across Europe D. It undermines the development of a pan-European capital market

answer

B. National authorities losing control over monetary policy

question

In a(n) ____, similarities in the underlying structure of economic activity make it feasible to adopt a single currency and use a single exchange rate as an instrument of macroeconomic policy. A. optimal currency area B. unified economic area C. uniform currency zone D. monetary zone

answer

A. optimal currency area

question

Which of the following was required for new applicants to qualify for EU membership? A. Minimum economy size of €1 trillion B. Nationalization of private assets C. Deregulation of markets D. Sustained GDP growth of 10 percent for five years

answer

C. Deregulation of markets

question

Which of the following is seen to be a consequence of the size of the EU from 15 nations to 27 nations? A. Delays in the decision-making processes B. Elimination of the sovereign debt crisis C. Euro becoming the most traded currency in the world D. Huge initial impact on the overall economic welfare

answer

A. Delays in the decision-making processes

question

Which of the following is a reason why Turkey is not yet a member of the EU? A. Because only about 10 percent of Turkey's international trade is with the EU. B. Because of concerns over human rights issues in the country. C. Because the country has yet to form a customs union with the EU. D. Because of Turkey's weak economy.

answer

B. Because of concerns over human rights issues in the country.

question

How does the NAFTA seem to increase the international competitiveness of U.S. and Canadian firms? A. It gives them access to scarce natural resource hitherto unavailable. B. It increases tariff barriers making the North American market less attractive to Asian companies. C. It allows them to take advantage of lower labor costs in Mexico. D. It gives them production bases in South American markets like Brazil and Argentina.

answer

C. It allows them to take advantage of lower labor costs in Mexico.

question

What was the main objection raised by those in the United States and Canada who opposed the ratification of the NAFTA? A. Job losses B. Balance of payment problems C. Threat of competition from Asian companies D. Threat of a loss of national sovereignty

answer

A. Job losses

question

Bolivia, Peru, Ecuador, Columbia, and Venezuela are all members of: A. Mercosur. B. NAFTA. C. APEC. D. the Andean Pact.

answer

D. the Andean Pact.

question

Mercosur originated as a(n) _____ between Brazil and Argentina in 1988. A. common market B. free trade pact C. customs union D. economic union

answer

B. free trade pact

question

According to Alexander Yeats: A. the trade diversion effects of Mercosur outweigh its trade creation effects. B. the fastest growing items in intra-Mercosur trade were capital-intensive goods produced efficiently in the member countries. C. Mercosur countries will be able to compete globally once the group's external trade barriers come down. D. the customs union is becoming more perfect over time.

answer

A. the trade diversion effects of Mercosur outweigh its trade creation effects.

question

In early 2006, six CARICOM members and the United States established the ____, which was modeled on the EU's single market. A. Central American Common Market B. Central America Free Trade Agreement C. Caribbean Single Market and Economy D. North American Free Trade Area

answer

C. Caribbean Single Market and Economy

question

What has been the most significant impact of NAFTA? A. Its economic effects B. Its political effects C. Its psychological effects D. Its social effects

answer

B. Its political effects

question

Which of the following is true of ASEAN? A. China, India, South Korea, and Singapore are among its members. B. Collectively, the member states account for about 55 percent of world trade. C. It is slowly progressing toward establishing a free trade zone. D. It has been successful in fulfilling its basic objective of fostering freer trade between member countries.

answer

C. It is slowly progressing toward establishing a free trade zone.

question

Which of the following accounts for about 55 percent of the world's GNP and 49 percent of world trade? A. NAFTA B. APEC C. ASEAN D. EFTA

answer

B. APEC

question

Which of the following is the most frequently aired objection to free trade in Africa? A. These economies are too small for free trade to exist. B. These countries are not ready for a full-fledged political union with a common currency. C. They need to be "protected" by tariff barriers from unfair foreign competition. D. The larger nations like South Africa and Kenya stand much to lose from free trade and competition.

answer

C. They need to be "protected" by tariff barriers from unfair foreign competition.

question

The lowering of barriers to trade and investment between countries is likely to lead to _____ throughout the EU. A. higher costs of borrowing B. increase prices C. increase in hedging costs D. increased price competition

answer

D. increased price competition

STUDY

European Free Trade Association Pharmacology

CITI training – Flashcards with Answers 134 terms

Marvel Brown

134 terms

Preview

CITI training – Flashcards with Answers

question

What must you file before conducting human clinical trials with an experimental drug?

answer

IND application (Form FDA 1571)

question

During the clinical development phase of the IND process, what must sponsors do?

answer

Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports

question

this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND.

answer

Form FDA 1572

question

What is the timeline of drug development?

answer

Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV)

question

When does a sponsor submit the IND?

answer

Prior to clinical development phases (human trials). *30 day process.

question

What is the NDA?

answer

New Drug Application, submitted prior to Phase IV marketing phase.

question

How long does the NDA submission take?

answer

6 months - 2 years.

question

What is determined for a drug in the preclinical phase

answer

Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying.

question

How long does FDA have to review IND submission?

answer

30 days

question

How long is the clinical development phase (Phase 1-III) in process for IND?

answer

6-7 years.

question

Determine the trial phase: - Assess toxicity - Determine drug's PK and PD profiles - Determine doses resulting in sufficient biological level of drug

answer

Phase I

question

Determine the trial phase: - Determine drug's effectiveness (primary goal) - Determine long-term drug safety - Confirm findings

answer

Phase III

question

Determine the trial phase: - Determine drug's short-term risk (safety) (primary goal) - Examine preliminary effectiveness of drug

answer

Phase II

question

Determine the trial phase from the subject population: Controlled studies enrolling limited numbers of patients

answer

Phase II

question

Determine the trial phase from the subject population: Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers.

answer

Phase III

question

Determine the trial phase from the subject population: Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this, case patients with end-stage disease might be enrolled.

answer

Phase I

question

If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start?

answer

Yes, one of two conditions must be met. 1. 30 days elapsed since FDA received IND application and no hold as been placed. 2. Correspondence has ben received from FDA allowing the trial to start.

question

What must be provided to investigators before they beginning conducting trials at their site?

answer

Protocol and Investigator's Brochure

question

What regulation must a PI comply with in order to use an edc system for a clinical trial?

answer

21 CFR Part 11

question

21 CFR 56.115(b)

answer

question

21 CFR 312.57

answer

question

21 CFR 312.62

answer

question

21 CFR 812.140

answer

question

What happened because of the concern and confusion regarding interpretation of Part 11in 2003.

answer

FDA withdrew all the guidance documents related to Part 11, while re-examining. They then issued: Guidance for Industry: Part 11, Electronic Records; Electronic Signatures-Scope and Application (2003) and Guidance for Industry: Computerized Systems Used in Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance"

question

Development of most new drugs from discovery to marketing approval usually takes:

answer

9 years or more

question

The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 patients in each arm. Which of the following best describes the clinical phase of this study?

answer

Phase 2

question

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?

answer

Phase 3

question

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

answer

Preclinical

question

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

answer

Phase 1

question

For a Phase 1 new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?

answer

Preclinical data

question

What is ICH's more specific name?

answer

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

question

what is the goal of the ICH?

answer

to minimize redundant research. and standardize technical guidelines and requirements.

question

Define the term: an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research

answer

Legally Authorized Representative (LAR)

question

an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change.

answer

Protocol Deviation (or Violation)

question

What are the 6 regulatory and pharmaceutical industry groups that have representatives working for ICH?

answer

-European Commission (EC) -European Federation of -Pharmaceutical Industries' Association (EFPIA) -Ministry of Health, Labor, and Welfare, Japan (MHLW) - Japan Pharmaceutical Manufacturers Association (JPMA) - US Food and Drug Administration (FDA) - Pharmaceutical Research and Manufacturing of America (PhRMA)

question

How do the World Health Organization (WHO) and the European Free Trade Association (EFTA) [represented by Swissmedic, and Health Canada participate with ICH?

answer

As observers.

question

How is the ICH governed?

answer

a Steering Committee

question

Who supports the ICH?

answer

the ICH Secretariat

question

Who provides the ICH secretariat?

answer

The International Federation of Pharmaceutical Manufacturers Association (IFPMA)

question

How many seats on the Committee does each of the 6 working groups of ICH have?

answer

question

who nominates other nonvoting participants to attend ICH steering Committee meetings?

answer

The observer groups (WHO, Health Canada, and EFTA)

question

Is the ICH GCP regulation or guideline?

answer

Depends, several countries adopted it as law, but the U.S FDA adopted it only as guidance. (Federal Register, Vol. 62, MAY 9, 1997)

question

What are the four main categories covered by ICH guidelines?

answer

Q: Quality topics (chemical and pharmaceutical assurance) S: Safety topics: in vitro and in vivo preclinical research E: Efficacy topics: relating to research in human subjects M: Multidisciplinary topics: those that do not fit uniquely into one of the above categories. (QSEM)

question

What are the expert working groups responsible for?

answer

developing specific guidelines. * The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries.

question

ICH E6 guideline pertains specifically to what

answer

the conduct of clinical research to support marketing applications for drugs.

question

Provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.

answer

ICH E6 guideline for good clinical practice.

question

What are the two important goals of the ICH E6 standard?

answer

To assure that 1: The rights, well-being, and confidentiality of trial subjects are protected. 2: Trial data are credible.

question

Where do the ethical principles followed by ICH GCP guidelines originate from?

answer

the Declaration of Helsinki

question

What ethical principles stem from the Declaration of Helsinki?

answer

in notes....

question

If planning to market drugs outside the US, what guidance must a PI follow while conducting the clinical trial?

answer

ICH E-6 Good Clinical Practice.

question

Can an employee at the research site be witness to a patient's consent?

answer

No, they are involved in the trial. Witness must be "a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial"

question

What must a witness do before the consent process starts?

answer

Read the consent form and other written information provided to the participant. They must also determine whether the participant has any other questions and should sign the impartial witness signature block on the consent document.

question

If following ICH guidelines who all should sign the consent form between the subject, witness, and person obtaining consent.

answer

All of them.

question

Define: Oversee research involving human subjects to assure the protection of their rights, safety, and welfare.

answer

IRBs/IECs

question

FDA or ICH: requires the consent form to include a statement that "monitors, auditors, the IRB/IEC, and the regulatory authorities will be granted access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access

answer

ICH GCP

question

FDA or ICH: Treatment alternatives only need to be listed in the consent form

answer

FDA

question

FDA or ICH: requires that the potential benefits and risks of the alternatives should also be included in the consent form.

answer

ICH

question

What does the ICH E6 guidelines require in a consent form for treatment arms.

answer

Description of each arm, the likelihood of being assigned to each of the study arms, and an explanation of " the subject's responsibilities"

question

Does FDA require description in consent if research provides no expected benefit?

answer

No, only an explanation of expected benefits of the research?

question

What does ICH require in terms of benefits in the ICF?

answer

If there is no intended clinical benefit to the subject, Section 4.8.10(h) requires that the subject be made aware. Consent form should describe the anticipated prorated payments to subjects (recommended for FDA as well)

question

Is assent required for both FDA and ICH?

answer

Yes, and the consent of the parents.

question

Define Assent

answer

The agreement of someone who cannot consent for his or herself.

question

When is there a valid reason not to require assent?

answer

question

FDA vs. ICH when enrolling an adult who is unable to consent for him or herself.

answer

ICH E6 requires assent along with permission from their LARs. Not required by FDA.

question

ICH or FDA: Only subjects who are able to consent for themselves are allowed to enroll in non-therapeutic research studies (a trial in which there is no anticipated direct clinical benefit to the subject.

answer

ICH

question

When can ICH allow subjects to be enrolled that cannot consent for themselves? (Exceptions)

answer

studies where: - the objectives cannot be met without including these subjects. the foreseeable risks to the subject are low as is the negative impact. - the study is not illegal AND The IRB/IEC has specifically agreed to include these subjects.

question

T/F: FDA requires Investigator to inform the subject's primary physician about the subject's participation in the trial if subject has a PCP and if the subject agrees to the primary physician being informed.

answer

False, this is a requirement of ICH E6 guidelines.

question

FDA or ICH requirement: IRB/IEC is required to review -written ICF and updates - trial protocols/amendments - subject recruitment procedures (advertisements) - written information to be provided to subjects - IBs Safety information Info about payments and compensation to subjects - CVs and qualifications - any other docs IRB/IEC may require to fulfill its responsibilities

answer

ICH E6 Guideline. FDA not clear in requirements for IRB/IEC review of documents.

question

Per FDA requirements, what is required of the IRB/IEC?

answer

to review the consent form (21 CFR 56.109) and to keep "copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents.

question

A primary purpose of the ICH is to: - require publication of negative trial results. - develop mandatory worldwide regulations for drug development. - require FDA registration of worldwide clinical trials. - minimize the need for redundant research

answer

Minimize the need for redundant research.

question

The ICH GCP guidelines: - set standards for the design, conduct, monitoring and reporting of clinical research. - guarantee that a submission in any ICH region will be approved for marketing. - require certification of clinical research sites and investigators - replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.

answer

Set standards for the design, conduct, monitoring and reporting of clinical research.

question

The ICH E6 GCP describes standards that apply to: -Investigators, sponsors, and IRBs. - Research sponsors only - Investigators only - IRBs only

answer

Investigators, sponsors, and IRBs.

question

In the United States, following the ICH E6 GCP is: - Voluntary for FDA-regulated drug studies. - Mandatory for studies conducted outside the United States. - Mandatory for investigational device studies. - Mandatory for drug studies.

answer

Voluntary for FDA-regulated drug studies

question

The FDA will apply: - The ICH E6 GCP standards - The Code of Federal Regulations - Local IRB requirements - State law where the sponsor's headquarters are located.

answer

The code of federal regulations

question

What is the legal status of ICH in the U.S.?

answer

It is a guideline

question

Regarding subject signature on consent forms, which is true about dates?

answer

Both the FDA and ICH require

question

ICH requires a witness when enrolling illiterate subjects, true or false?

answer

True

question

Regarding probability of assignment to trial arms in consent forms, which is true?

answer

Only ICH recommends.

question

When is there "Sponsor-investigators"

answer

Investigator-initiated trials of investigational drugs.

question

Who addresses the role of "Sponsor-investigators?"

answer

FDA

question

means in addition to producing the drug, the company also supplies the investigator with the drug for use in the study

answer

Drug Supplier/Manufacturer

question

means the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. The intent of the sponsor's IND is to allow testing for marketing approval of the drug. These are generally considered commercial or corporate INDs. Note: the sponsor is often but not always the entity that funds the clinical research.

answer

Sponsor

question

means an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational drug is being administered, used, or dispensed. The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator as outlined in the Form FDA 1572 (see the module, Investigator Obligations in FDA-Regulated Research). Usually, the intent of the sponsor-investigator trial is to gain scientific knowledge without seeking market approval for the drug. These are considered investigator-initiated or sponsor-investigator trials.

answer

Sponsor-investigator

question

Usually, the intent of the sponsor-investigator/investigator-initiated trial is to

answer

gain scientific knowledge without seeking market approval for the drug.

question

the regulation stating: exception from informed consent for emergency research

answer

21CFR 50

question

What can Investigators reference when unsure if an IND is required for a study of an approved drug?

answer

IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer OR seek opinion from FDA.

question

Form FDA ______: Statement of the Invesitgator

answer

1572

question

Form FDA ____: Investigational New Drug Application, NDA

answer

1571

question

detailed requirements for the content and format of an IND can be found in

answer

21 CFR 312

question

what can be cross-referenced when the manufacturer of an IND already has an active IND for the drug being studied?

answer

Chemistry, manufacturing, and controls (CMC) information Pharmacology and toxicology information Previous human experience with the drug

question

Form: contractual agreement between the sponsor and FDA.

answer

FDA 1571

question

21 CFR 56

answer

IRBs

question

The content for an IND for studies of marketed products is the same as the content for studies of new drugs, with the following exception:

answer

a copy of the approved labeling (including the package insert) can be provided in lieu of the Investigator's Brochure.

question

what are the three types of protocol amendments?

answer

-new sponsor protocol -a change in an existing protocol when the entire sponsor protocol is not revised - identifying and adding new investigator to a study

question

submitted when new toxicology, chemistry, or other technical information is available. Study discontinuation is also submitted as this.

answer

Information amendments

question

When do Annual Reports need to be submitted to the FDA?

answer

within sixty (60) days of the anniversary date that the IND went into effect.

question

The following are purposes of what: -The rights and well-being of human subjects are protected. -The reported trial data are accurate, complete and verifiable from source documents. -The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

answer

Trial monitoring

question

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? A. IND renewal application B. Adverse Event Summary Report, but only from unblinded portions of studies ("open-label IND safety report") C. IND report D. Marketing plan (i.e. annual updated projection of sales and profits)

answer

C. IND report

question

Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND? A. The study intends to invoke an exception from informed consent. B. The study involves a route of administration that significantly increases the risks to the patient. C. The study is not intended to be reported to FDA to support a new indication or support a labeling change. D. The study intends to involve more than 100 patients in a study.

answer

C. The study is not intended to be reported to FDA to support a new indication or support a labeling change.

question

Which of the following reports must be filed using an FDA Form 1572? A. Annual Reports B. Addition of a new investigator C. Protocol amendments

answer

B. Addition of a new investigator.

question

the tool used to record data collected during a clinical trial

answer

CRF, case report form

question

document that includes information needed for potential subjects to have sufficient info to provide informed consent to participate in a clinical trial. The FDA regulations and ICH E6 describe the information that must be included in the consent form.

answer

Informed Consent Document

question

any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. " Assure the protection of the rights and welfare of the human subjects.

answer

IRB

question

All info in original records and certified copies of original records of clinical findings ETc

answer

source data.

question

Initial documentation of data in a clinical study and includes recorded observations, laboratory reports, medical records, etc.

answer

Source Document.

question

This agreement is a contract that defines both the terms of study conduct and the financial agreements

answer

CTA (Clinical Trial Agreement)

question

When is it necessary for an investigator to complete and sign a new 1572?

answer

- when participating in a new protocol that has been added to the IND - When a new investigator is added to the study.

question

What needs to be done when there are other changes to information contacted on a signed and dated 1572? (IRB/IEC address change, addition of a clinical research lab)

answer

investigator should document the changes in the clinical study records and inform the sponsor of the changes, so that the sponsor can appropriately updated the IND.

question

ICH or FDA, requires submission of up to date curriculum with changes?

answer

ICH

question

clinical trials of drugs or devices from which the data will be submitted to the FDA to support a marketing application or relied upon by the FDA to establish effectiveness.

answer

"covered clinical studies"

question

For purposes of financial disclosures, the term (blank) includes anyone who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the (blank).

answer

Investigator

question

21 CFR 54

answer

Financial Disclosure by Clinical Investigators

question

The investigator's financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation is reported directly to the FDA by: A) The investigator's institution B) The investigator C) The IRB D) The sponsor

answer

D. The sponsor

question

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: A) Maintain a contract with the sponsor B) Maintain records indefinitely C) Report to the FDA any adverse events that occur. D) Conduct or supervise the investigation personally

answer

D. Conduct or supervise the investigation personally.

question

Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: A) Subjects B) Sponsor C) FDA D) IRB

answer

C) FDA

question

The investigator must report adverse events to the: A) Subject B) Sponsor C) FDA D) IRB only

answer

B) Sponsor

question

When must the investigator update the IRB about the progress of a trial? A) During the conduct of the study and at termination B) During the conduct of the study only C) Never D) At study termination only

answer

A) During the conduct of the study and at termination

question

Which of the following is an investigator's commitment to the sponsor? A) Submit documents to sponsor for yearly approval to continue the study B) Retain study documents for 3 years after study completion at the site C) Provide the financial disclosure document directly to FDA D) Submit a new FDA form 1572 to sponsor as needed

answer

D) Submit a new FDA form 1572 to sponsor as needed

question

"...any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries"

answer

Biological Product (Biologic)

question

"...a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use" (ICH GCP E6 Section 1.33).

answer

Investigational Drug

question

"...a new drug, antibiotic drug, or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes" (21 CFR 312.3).

answer

Investigational New Drug (IND)

question

Which of the following is an important component of drug accountability? A) Environmental controls B) Drug shipping and disposition records C) Patent expiration date D) Manufacturer's compounding procedures

answer

Drug shipping and disposition records

question

Who has ultimate responsibility for an investigational product?

answer

Investigator

question

Investigational product dispensing or administration info for the sponsor is recorded on the:

answer

Case Report Form

question

The packaging of investigational drugs should ideally A) look like a marketed product B) allow subjects to identify placebo pills C) be designed to help with subject compliance D) be attractive so the study coordinators will use it

answer

be designed to help with subject compliance

question

Where is info on storage requirements for the investigational product usually found? A) on the product code-breaker label B) In the CRF directions C) In the drug accountability log D) In the study protocol

answer

in the study protocol

question

A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

answer

Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug

question

Which of the following statements in a consent form is an example of language that appears to waive a subject's rights?

answer

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

question

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:

answer

The investigator and another physician who is not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

question

Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

answer

The study is minimal risk.

question

Which of the following should take place during periodic site visits?

answer

Identification of protocol violations

question

Which of the following best describes when the majority of CRF data are verified against source record information?

answer

Periodic site visits.

question

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?

answer

Site initiation visit.

question

The FDA requires retention of investigational drug study records for:

answer

At least 2 years after the investigational drug's approval by the FDA.

STUDY

Central And Eastern Europe European Countries European Free Trade Association Free Trade Agreement Global Marketing Strategy International Marketing Principles Of Marketing

Global Marketing Test Questions – Flashcards 20 terms

Patsy Brent

20 terms

Preview

Global Marketing Test Questions – Flashcards

question

A fundamental difference between regular marketing and global marketing is:

answer

the scope of activities

question

Starbucks is building on its loyalty card and rewards program in the United States with a smartphone app that enables customers to pay for purchases electronically. The app displays a bar code that the barista can scan. This is an example of

answer

Market Penetration

question

The essence of marketing worldwide is to surpass the competition in creating perceived value, which can be represented as

answer

Benefits/Price

question

According to Michael Porter, a global industry is one in which ________ can be achieved by integrating and leveraging operations on a worldwide scale.

answer

competitive advantage

question

The decision to enter one or more particular markets outside the home country depends on all of the mentioned factors

answer

threats, company's resources, company's managerial mind-set, nature of opportunities.NOT companies age

question

Coca-Cola achieved success in the Japanese market primarily b

answer

global localization

question

Measured by national income, the United States represents the world's largest single market for goods and services. Roughly what percentage of world income is found outside the U.S.?

answer

75%

question

The cell phone divisions of Toshiba, Sharp, and other Japanese companies prospered by focusing on the domestic market. When handset sales in Japan slowed a few years ago, the Japanese companies realized that Nokia, Motorola, and Samsung already dominated key world markets. Atsutoshi Nishida, president of Toshiba, noted, "We were thinking only about Japan. We really missed our chance." This example illustrates:

answer

ethnocentric orientation

question

Transnational companies, such as Toyota and Honda, have characteristic features that includ

answer

a. being in both global markets and utilizing global supply chains. b. using both localized and standardized elements in marketing programs. Incorrect c. decisions made on the basis of ongoing research. d. characterized by a mind-set of being "stateless." ANSWER=ALL OF THE ABOVE

question

In the United States, some people believe that globalization has depressed the wages of American workers and resulted in the loss of both blue-collar and white-collar jobs. This is an example of

answer

globaphobia

question

During the past two decades, the world economic environment has become increasingly dynamic. To achieve success, executives and marketers must take into account all of the following realities

answer

a.capital movements have replaced trade as the driving force of the world economy. b.production has become "uncoupled" from employment. d. the growth of e-commerce diminishes the importance of national barriers. e.the world economy dominates the scene. NOTc. the struggle between capitalism and socialism continues

question

Market capitalism is an economic system in which:

answer

individuals and firms allocate resources and production resources that are privately owned

question

Low-income countries have a GNI per capita of less than $996. The general characteristics shared by countries at this income level include all of the following

answer

a. high agricultural population. c. high birth rates. d. heavy reliance on foreign aid. e. political unrest. NOT . high literacy rates.

question

The majority of the world's population is included in the following economic category

answer

. lower-middle-income countries.

question

Upper-Middle-income countries are also know as:

answer

Industrializing countries

question

Nike produces only a small portion of its output in China, but when the firm refers to China as a "two-billion-foot market," it is referring to the fact tha

answer

China is a potential future market

question

Product and market opportunities in a postindustrial society are more heavily dependent upon new products and innovations than in industrial societies. An example of this would be

answer

New e-commerce markets for interactive forms of electronic communication

question

The term "Expanded Triad" includes all of the following countries or region

answer

a.Japan c. Mexico d. United States e. Canada NOT RUSSIA

question

To the extent that a country sells more goods and services abroad than it buys, there will be:

answer

a greater demand for its currency

question

When countries or regions experience currency and/or economic stress, all of the following events can take place

answer

a. new profit opportunities. b. cancellation of aircraft equipment sales.. d. increased exposure to certain risks. e. bad debts occur. NOT lower local currency financing costs

STUDY

European Free Trade Association Free Trade Area Free Trade Association Regional Economic Integration Single European Act

Global 9,10,11 – Flashcards 67 terms

Ray Collins

67 terms

Preview

Global 9,10,11 – Flashcards

question

A regional free trade agreement will benefit the world only if:

answer

The amount of trade it creates exceeds the amount it diverts

question

A(n) ____ has no barriers to trade between member countries, includes a common external trade policy, and allows factors of production to move freely between members.

answer

Common market

question

An agreement between countries in a geographic region to reduce tariff and nontariff barriers to the free flow of goods, services, and factors of production between each other is referred to as:

answer

Regional economic integration

question

All of the following were objectives of the Single European Act EXCEPT:

answer

Increasing the powers of the European Commission in matters of competitive policy

question

Bolivia, Chile, Ecuador, Colombia, and Peru signed an agreement in 1969 to create the:

answer

Andean Pact

question

In 1990, the MERCOSUR pact was expanded to include:

answer

Paraguay and Uruguay

question

The most enduring free trade area in the world is the:

answer

European Free Trade Association

question

The principle argument of those who opposed NAFTA centered on the fear that ratification would result in:

answer

Mass exodus of jobs from the United States into Mexico

question

The two main reasons that have made regional economic integration difficult to achieve are:

answer

Concerns about costs and national sovereignty

question

There are now two trade blocs in Europe. These are the:

answer

European Union and European Free Trade Association

question

What was the objective of the Single European Act?

answer

It committed member countries to work toward establishment of a single market by December 31 1992.

question

Which of the following countries are currently members of the European Free Trade Association (EFTA)?

answer

Norway, Iceland, Liechtenstein, and Switzerland

question

Which of the following is transacted when it is desirable to move out of one currency into another for a limited period without incurring foreign exchange risk?

answer

Swap

question

Which of the following is a major reason why governments limit convertibility of their currency?

answer

To preserve their foreign exchange reserves

question

How are spot exchange rates in the foreign exchange markets determined?

answer

By the relative demand and supply for different currencies

question

Which of the following is a key feature of the foreign exchange market

answer

The market never sleeps

question

Which of the following refers to the purchase of securities in one market for immediate resale in another to profit from a price discrepancy?

answer

Arbitrage

question

Assume that the yen/dollar exchange rate quoted in London at 3 p.m. is $1 = $100Yen and that the yen/dollar exchange rate quoted in New York at the same time is $1 = 120. Which profit making situation exists here?

answer

Arbitrage

question

Currency carry trade takes advantage of:

answer

Differences in interest rates between countries

question

Which of the following occurs when the quantity of money in circulation rises faster than the stock of goods and services?

answer

Inflation

question

The rapid rise in the value of the dollar on the foreign exchange market in the 1990s hurt the price competitiveness of many U.S. producers in world markets. U.S. manufacturers that relied heavily on exports saw their export volume and world market share decline. This is an example of:

answer

Economic Exposure

question

In 2002-2007, the euro rose in value against the dollar. This boosted the dollar profits of American multinationals with significant operations in Europe. Which of the following is this an example of?

answer

Translation exposure

question

A currency is said to be _____ when only nonresidents may convert it into a foreign currency without any limitations.

answer

Externally convertible

question

A U.S. company that imports laptop computers from Japan knows that in 30 days it must pay yen to a Japanese supplier when a shipment arrives. The company will pay the Japanese supplier ×150,000 for each computer, and the current dollar/yen spot exchange rate is $1 = ×110. The importer knows she can sell the computers the day they arrive for $1,600 each. However, the importer will not have the funds to pay the Japanese supplier until the computers have been sold. The importer enters into a 30-day forward exchange transaction with a foreign exchange dealer at $1 = ×105. Which of the following will happen if the exchange rate after 30 days is $1 = ×90?

answer

The importer will earn a profit of $171 per computer

question

Assume that the exchange rate between the euro and the dollar is € 1 = $1.20. A camera that retails for $300 in New York sells for € 200 in Berlin. Ignoring any transaction costs or barriers, this represents an initial arbitrage profit potential of:

answer

$60

question

You exchanged $1,000 to 105,000 yen for a trip to Japan. During your stay, you spent 50,000 yen. Also, during this period the dollar weakened against the yen to 100 to a dollar. On your return, you went to the bank to exchange the remaining yen. How many dollars did you spend on the trip?

answer

$450

question

A French company has 20 million euros it wants to invest for three months. Investing in a Thai money market account gives the company a higher return than domestic investments. Is this investment risk-free? Why or why not?

answer

No, because foreign currency movements in the intervening period can affect the profitability.

question

A _____ is the simultaneous purchase and sale of a given amount of foreign exchange for two different value dates.

answer

Currency swap

question

Assume that the dollar is selling at a premium on the 30-day dollar/euro forward market. Which of the following reflects the foreign exchange dealers' expectations about the dollar over the next 30 days?

answer

The dollar will appreciate against the euro

question

The theory of purchasing power parity (PPP) links changes in the exchange rate between two countries' currencies to:

answer

Changes in the countries' price levels

question

Which is the most important foreign exchange trading center in terms of percentage of activity?

answer

London

question

_____ refers to a range of barter-like agreements by which goods and services can be traded for other goods and services.

answer

Countertrade

question

A floating exchange rate is a system under which the exchange rate for converting one currency into another is continuously adjusted depending on the law of supply and demand.

answer

True

question

Since the Bretton Woods system of floating exchange rates collapsed in 1973, the world

answer

False

question

A dirty float is called so because the central bank of a country will intervene in the foreign exchange market to try to maintain the value of its currency if it depreciates too rapidly against an important reference currency.

answer

True

question

The Central bank is similar to a Currency board and both act as banks of last resort

answer

False

question

The Bretton Woods agreement legalized the use of devaluation as a tool of competitive trade policy.

answer

False

question

A fixed exchange rate regime imposes monetary discipline on countries, thereby curtailing price inflation.

answer

True

question

If the IMF agrees that the country's balance of payments is in "fundamental disequilibrium," the system of adjustable parities allows for the devaluation of a country's currency by more than 10 percent.

answer

True

question

One criticism of the IMF is that its traditional policy prescriptions represent "one-size-fits-all" approach to macroeconomic policy that is inappropriate for many countries.

answer

True

question

Which of the following refers to the institutional arrangements countries adopt to govern exchange rates? - International Monetary Fund - Global agreement on exchange rates - International monetary system - Bretton Woods Arrangement

answer

International Monetary System

question

When the foreign exchange market determines the relative value of a currency, the country is said to adhere to a _____ exchange rate regime.

answer

Floating

question

The voting rights within the IMF are roughly proportionate to the___________ _________made by member nations. The US has 17% of the vote followed by Japan and Germany. US, Japan and Europe together account for more than 80% of the vote in the IMF. The breakdown of the democratic process becomes clear as the Jamaican people are removed from participation in the decisions that truly affect their lives.

answer

Economic contributions

question

A free trade zone is a:

answer

Geographical area in which commerce can be conducted without tariffs being applied

question

The IMF assumes that the combination of increased interest rates and ________ ______ ________ ________ will shift resources from domestic consumption to private investment. It is further assumed that keeping the price of local labor down will be an incentive for increasing employment and production.

answer

Cutbacks in government spending

question

The central bank is government owned and not separate from the country's finance ministry

answer

False

question

One of the factors that contributed to the Mexican crisis was that the central bank began converting short term debt, denominated in pesos, into dollar- denominated bonds. This conversion resulted in an increase in foreign reserves and a decrease in debt.

answer

False

question

All of the following contributed to the Asian crisis of 1997 except:

answer

Production driven by domestic demand

question

Identify the countries worst affected by the Southeast Asian crisis of 1997?

answer

Indonesia, Thailand, and South Korea

question

The Asian meltdown began in mid-1997 in _____ when it became clear that several key financial institutions were on the verge of default.

answer

Thailand

question

Which of the following actions by the Mexican government in December 1994, exacerbated the sale of the peso and contributed to the rapid 40 percent drop in its value?

answer

Currency devaluation

question

Which of the following economies in Southeast Asia was considered relatively more stable during the crisis on 1997?

answer

Singapore

question

Which of the following was the objective of establishing the International Monetary Fund (IMF)?

answer

Maintain order in the international monetary system

question

In 2001, the WTO launched a new round of talks aimed at further liberalizing the global trade and investment framework. It was held at:

answer

Doha

question

One concern of globalization critics is that a global economy shifts economic power away from _____ and toward _____.

answer

National governments; supranational organizations

question

Many economists and business leaders believe that globalization offers several benefits including:

answer

Rising incomes of consumers

question

One of the consequences of globalization that is appreciated by people from developing countries is that:

answer

The changes that progress has brought to their standard of living

question

Opponents of outsourcing in advanced economies like the U.S. and Western Europe contend that:

answer

Falling trade barriers allow firms to move manufacturing activities to countries where wage rates are much lower.

question

Supporters of globalization insist that dislocation in the form of lost jobs is a trade-off that will ultimately lead to the economy being better off. What are they justifying in this case?

answer

Free trade

question

The principle argument of those who opposed NAFTA centered on the fear that ratification would result in:

answer

Mass exodus of jobs from the United States into Mexico

question

Which three countries implemented the NAFTA?

answer

Canada, Mexico, and the United States

question

When is capital flight most likely to occur?

answer

When domestic currency depreciates rapidly because of hyperinflation

question

The absence of a legal system that protects property rights and the machinery to enforce that system usually results in:

answer

A reduction in the incentive to engage in productive economic activity

question

Five of the fastest-growing economies of the past 30 years—China, South Korea, Taiwan, Singapore, and Hong Kong—had one thing in common at the start of their economic growth:

answer

Undemocratic governments

question

Peruvian development economist Hernando de Soto has argued that much of the developing world will fail to reap the benefits of capitalism until:

answer

Property rights are better defined and protected

question

What happens when governments control or dominate a national economy?

answer

Businesses are greatly restricted with the government doing most of the controlling and siphoning.

question

Is there a relationship between open markets and political freedom?

answer

It is true that some totalitarian governments can have open markets

STUDY

Business Management European Free Trade Association Free Trade Association Regional Economic Integration

Global Test 2 – Flashcards 60 terms

Aiden Boyd

60 terms

Preview

Global Test 2 – Flashcards

question

A group of nations in a geographic area undergoing economic integration is called a ________.

answer

Regional trading bloc

question

A group of fifty-three nations on the African continent joined forces in 2002 to create the ________.

answer

African Union

question

For countries to become members of the European Union, they have to meet certain demands laid down by the EU referred to as the ________.

answer

Copenhagen Criteria

question

The common currency of the European Union is known as the ________.

answer

Euro

question

The least amount of sovereignty that must be surrendered to a trading bloc occurs in a ________.

answer

Free trade area

question

Which of the following countries is a member of the North American Free Trade Agreement (NAFTA)?

answer

Canada

question

Which of the following is the lowest extent of regional economic integration?

answer

Free trade area

question

________ require that member countries concede a certain amount of their national autonomy to the supranational union of which they are a part.

answer

Economic unions

question

The Court of Justice is the ________ of the European Union.

answer

Court of appeals

question

The Free Trade Area of the Americas (FTAA) is a trade agreement ________.

answer

that has been proposed to create the largest free trade area on the planet

question

An exchange rate of ¥117.87/$ indicates ________.

answer

that 117.87 yen buys one dollar

question

An offshore financial center is usually characterized by

answer

excellent telecommunications

question

Company debt normally takes the form of ________.

answer

bonds

question

Eurobonds are popular because ________.

answer

governments of nations in which they are sold do not regulate them

question

Investors use the foreign exchange market for

answer

currency speculation

question

The absence of government regulation in the Eurobond market

answer

substantially reduces the cost of issuing a bond

question

The exchange rate at which a bank will purchase a currency is called a __________ rate

answer

buy

question

The purchase or sale of a currency with the expectation that its value will change and generate a profit is called

answer

currency speculation

question

_______ is the simultaneous purchase and sale of foreign exchange for two different dates.

answer

Currency Swap

question

Foreign bonds issued in the U.S. are called ________.

answer

yankee bonds

question

A company selling in a country with a strong currency while sourcing from a country with a weak currency ________.

answer

improves its profits

question

According to the efficient market view, future exchange rates are most accurately forecasted by ________.

answer

forward exchange rates

question

In the earliest days of international trade, ________ was the internationally accepted currency for payment of goods and services.

answer

gold

question

The calculation of each currency's par value under the gold standard was based on the concept of ________.

answer

purchasing power parity

question

The lowering of taxes in the U.S. by its government is an example of the ________.

answer

fiscal policy

question

The World Bank was created by the ________.

answer

Bretton Woods Agreement

question

To cool off an inflationary economy, a government might ________.

answer

raise interest rates

question

Today's international monetary system is considered to be a ________ system.

answer

managed float

question

When a country's currency is weak, the price of its ________

answer

exports on world markets declines and the price of its imports increases

question

Which of the following is a reason for the failure of PPP to predict exchange rates accurately?

answer

PPP assumes no barriers to international trade while predicting exchange rates

question

business-level strategy in which a company exploits economies of scale is called a ________.

answer

low-cost leadership strategy

question

A company that is selling unprofitable business units is most likely following a ________ strategy.

answer

retrenchment

question

A team of top managers from both headquarters and international subsidiaries who meet to develop solutions to company-wide problems is referred to as a ________ team.

answer

global team

question

A ________ team is one composed of employees who work at similar levels in different operative departments in an organization.

answer

cross-functional

question

An organizational structure that organizes a company's entire global operations into countries or geographic regions is referred to as a(n) ________ structure.

answer

international alrea

question

Decentralized decision making is beneficial when ________.

answer

fast-changing national business environments put a premium on local responsiveness

question

Global products are most commonly seen in industries where there is ________.

answer

significant price competition

question

Organic growth refers to an organization's corporate strategy that relies on growth ________.

answer

generated internally

question

Which of the following statements is true of objectives?

answer

Objectives become more precise at the level of individual departments

question

Which of the following statements is true of the environmental forces that affect strategy formulation?

answer

approval of the host government is almost always necessary for making direct investments

question

A designated geographic region in which merchandise is allowed to pass with lower customs duties and/or fewer custom procedures is called a(n) ________.

answer

foreign trade zone

question

A restriction on the amount of a good that can enter or leave a country during a certain period of time is called a(n) ________.

answer

quota

question

Financial assistance given to domestic producers in the form of cash payments is an example of a(n) ________.

answer

subsidy

question

In which of the following ways did the Uruguay Round of Negotiations modify the original General Agreement on Tariffs and Trade (GATT) treaty?

answer

It helped standardize intellectual property rules around the world

question

One of the main goals of the World Trade Organization is to ________.

answer

settle trade disputes among its members

question

Purposely understaffing customs offices to cause time delays, requiring special licenses that take a long time to obtain, and requiring air carriers to land at inconvenient airports are all examples of ________.

answer

administrative delays

question

The purpose of ________ is to force companies from other nations to use local resources in their production processes, particularly labor.

answer

local content requirements

question

Which of the following best describes the infant industry argument?

answer

It states that a country's emerging industries need protection from international competition during their development until they become sufficiently competitive

question

Which of the following statements is true of embargoes?

answer

an embargo may be placed on one or a few goods or may completely ban trade in all goods

question

________ refers to the unwanted cultural influence in a nation that can cause great distress and lead governments to block imports it believes to be harmful.

answer

Cultural imperialism

question

A home country encourages outflows of foreign direct investment because it ________.

answer

tends to increase the long-term competitiveness of firms

question

According to the international product life cycle theory, in which of the following stages is a good produced in the home country because of uncertain domestic demand and to keep production close to the research department?

answer

new product stage

question

Home nations discourage foreign direct investment outflows because it ________.

answer

replaces jobs in the home nation

question

The purchase of physical assets or a significant amount of ownership of a company in another country to gain a measure of management control is called ________.

answer

foreign direct investment

question

When a U.S. company buys shares of stock in a French company on France's stock market, the U.S. balance of payments records the transaction as an ________.

answer

outflow of capital with a minus sign

question

Which of the following is a major driver of foreign direct investment?

answer

globalization

question

Which of the following is used by home country governments to limit outbound foreign direct investment?

answer

differential tax rates

question

What two factors propel growth in foreign direct investment?

answer

globalization and mergers and acquisitions

question

A country's ________ is a national accounting system that records all monetary transactions to entities in other countries and all receipts coming into the nation.

answer

balance of payments

question

Scenario: Happyland Happyland is a country characterized by beautiful beaches, vast natural resources, and a highly skilled labor force. Happyland is now encouraging foreign direct investment flows. The country has been exporting textiles, computer hardware, and software programs. The net result of the trade is that Happyland exports far more goods and services and receives more income from abroad than it imports and pays abroad. If Happyland advertises its beaches and attracts tourists, the tourism-related income would be recorded in its ________ account.

answer

services

STUDY

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