Chapter 1 - Introduction To The Industry
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Which best describes the Pharma industry?
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Low risk, high reward
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Low risk, low reward
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High risk, high reward
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High risk, low reward
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In the olden days people mostly chose to be farmers or miners but with the introduction of industries people moved to get job in cities which tended to grow with the introduction of new companies. What do you know about the manufacturing industry within your region? Take up the test below and see if you understood the basics from chapter See moreone on introduction to the industry. All the best of luck!
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- 2.
Which are the organizations that fall under the Food and Drug Administration (FDA)?
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Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Device & Radiology/Vet Medicine/Food Safety Centers, Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development
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Drug Enforcement Agency (DEA), Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Center for Biologics Evaluation and Research (CBER)
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Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product Development, Office of the Inspector General, Federal Trade Commission (FTC)
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Drug Enforcement Agency (DEA), Office of the Inspector General (OIG), Federal Trade Commission (FTC)
Correct Answer
A. Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Device & Radiology/Vet Medicine/Food Safety Centers, Office of Regulatory Affiars/Center for Toxicological Research/Office of Orphan Product DevelopmentExplanation
The organizations that fall under the Food and Drug Administration (FDA) include the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Device & Radiology/Vet Medicine/Food Safety Centers, and the Office of Regulatory Affairs/Center for Toxicological Research/Office of Orphan Product Development. These organizations are responsible for evaluating and regulating biologics, drugs, medical devices, radiology, veterinary medicine, food safety, toxicological research, and orphan products within the FDA.Rate this question:
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- 3.
The most powerful and influential pharma association designed to develop/regulate industry-wide guidelines is:
Correct Answer
Explanation
The most powerful and influential pharma association designed to develop/regulate industry-wide guidelines is likely the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the leading pharmaceutical research and biotechnology companies in the United States. It plays a crucial role in shaping policies and regulations that govern the pharmaceutical industry, advocating for innovation, patient access to medicines, and ethical business practices. With its extensive membership and influence, PhRMA has the capacity to drive industry-wide guidelines and standards, making it the most powerful and influential pharma association in this context.Rate this question:
- 4.
Due to the nature of Americans and the American health insurance system, health care has become very expensive. Its costs must somehow be controlled. What is the most common form of health insurance cost-control in this country?
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Indemnity-type coverage plans
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Restricted access to products/services
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Reduced level of service to patients depending on level of patient health insurance
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Increase the cost of most commonly use products
Correct Answer
A. Restricted access to products/servicesExplanation
The most common form of health insurance cost-control in the United States is restricted access to products/services. This means that health insurance plans often have limitations on which healthcare providers and services are covered, requiring individuals to seek care within a network or obtain referrals for specialized treatments. This approach helps insurance companies negotiate lower rates with specific providers and manage costs by limiting the options available to policyholders.Rate this question:
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- 5.
In the United States, what type of company dominates the pharmaceutical industry?
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Multi-national corporations
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Public, not-for-profit companies
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For-profit, private companies
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M Squared Life Sciences Practice
Correct Answer
A. For-profit, private companiesExplanation
For-profit, private companies dominate the pharmaceutical industry in the United States. These companies are driven by profit-making motives and are privately owned, meaning they are not publicly traded on the stock market. They have the ability to control pricing, research and development, and production of pharmaceutical drugs. This dominance allows them to prioritize financial gain over other considerations, potentially affecting access to affordable medications and the overall direction of the industry.Rate this question:
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- 6.
Which statement best describes the worldwide pharmaceutical industry?
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A giant, unethical body of greedy people
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Scientists without borders
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Drugs and lots of them
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A complex amalgam of science and business
Correct Answer
A. A complex amalgam of science and businessExplanation
The given answer, "A complex amalgam of science and business," best describes the worldwide pharmaceutical industry. This industry involves the combination of scientific research and development with business operations. It requires a deep understanding of scientific principles, drug discovery, clinical trials, and regulatory compliance, while also operating within a competitive market and aiming for profitability. The pharmaceutical industry is not solely driven by greed but rather a complex interplay between scientific advancements and commercial considerations.Rate this question:
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- 7.
Why does "Big Pharma" turn to smaller pharmaceutical companies?
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They are smaller so they carry less inherent risk making them a safer investment.
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They are more innovative and focused and can supplement the internal pipelines of their larger partners
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To help out when Big Pharma gets into trouble.
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Smaller pharmaceutical companies have less stringent regulatory standards to which they must adhere, thus bringing products to market more quickly.
Correct Answer
A. They are more innovative and focused and can supplement the internal pipelines of their larger partnersExplanation
Smaller pharmaceutical companies are more innovative and focused, allowing them to bring fresh ideas and approaches to the table. This can be beneficial for larger pharmaceutical companies as it helps supplement their internal pipelines, bringing in new drugs and therapies. By partnering with smaller companies, big pharma can tap into their expertise and benefit from their creativity and agility. This collaboration can lead to the development of more effective treatments and solutions for patients.Rate this question:
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- 8.
The two ways Pharma companies are generally structured:
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Large or small
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Research based or focused on meeting regulatory guidelines.
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Focused on meeting regulatory guidelines or maintaining high ethical standards
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Research based or focused on manufacturing
Correct Answer
A. Research based or focused on manufacturing -
- 9.
What role does Business Development play in a Pharmaceutical company?
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In-licensing, out-licensing and co-promotion
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Supply chain management, commercial manufacturing, customer service
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Legal, information technology, HR, finance and accounting
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Sales, marketing, and customer service
Correct Answer
A. In-licensing, out-licensing and co-promotionExplanation
Business Development plays a role in a Pharmaceutical company by managing in-licensing, out-licensing, and co-promotion. In-licensing involves acquiring external products or technologies to enhance the company's portfolio. Out-licensing refers to the process of granting external companies the rights to develop or commercialize the company's products. Co-promotion involves collaborating with other companies to jointly promote and sell products. These activities are essential for expanding the company's product offerings, accessing new markets, and maximizing revenue potential through partnerships and collaborations.Rate this question:
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- 10.
What three divisions/departments of a pharmaceutical company are responsible for accelerating the business, guiding the company in adhering to regulatory guidelines, and providing general administrative support?
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Research and development, marketing and sales, regulatory
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Marketing and sales, manufacturing and operations, corporate and administrative
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Marketing and sales, research and devlopment, manufacturing and operations
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Business development, regulatory, corporate and administrative
Correct Answer
A. Business development, regulatory, corporate and administrativeExplanation
The three divisions/departments of a pharmaceutical company that are responsible for accelerating the business, guiding the company in adhering to regulatory guidelines, and providing general administrative support are business development, regulatory, and corporate and administrative. Business development focuses on identifying and pursuing new opportunities to expand the company's business. Regulatory ensures compliance with regulations and guidelines set by regulatory authorities. Corporate and administrative provides general administrative support to the company's operations. This combination of divisions/departments helps the pharmaceutical company to grow, comply with regulations, and maintain smooth administrative processes.Rate this question:
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- 11.
What is the purpose of the FDA?
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Same as OSHA - to create obnoxious rules to which no one can adhere and to make nice people jump through a lot of hoops
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To prevent the production of harmful drugs, and to protect consumers against anti-competitive behavior and misleading claims
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To ensure drug safety and efficacy and to prevent misleading product claims and illicit inducements
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To regulate the distribution and use of narcotics and other controlled substances
Correct Answer
A. To ensure drug safety and efficacy and to prevent misleading product claims and illicit inducementsExplanation
The purpose of the FDA is to ensure drug safety and efficacy, meaning that they are responsible for regulating and monitoring the production, distribution, and use of drugs to ensure that they are safe and effective for consumers. Additionally, the FDA works to prevent misleading product claims and illicit inducements, meaning that they regulate the marketing and advertising of drugs to ensure that they are accurately represented and that false or misleading claims are not made.Rate this question:
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- 12.
What happens when a drug patent expires?
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Other companies are free to market drugs with the same active ingredient and equivilent efficacy.
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Other companies are free to market drugs with the same active ingredient but they must alter the efficacy so they are not creating an identical drug.
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Other companies may make drugs with an equivilent efficacy but they must contain a different active ingredient.
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A company loses its ability to market the product
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All hell breaks loose.
Correct Answer
A. Other companies are free to market drugs with the same active ingredient and equivilent efficacy.Explanation
When a drug patent expires, other companies are free to market drugs with the same active ingredient and equivalent efficacy. This means that these companies can produce and sell generic versions of the drug, which can be more affordable for consumers. However, they must still meet the same standards of quality, safety, and effectiveness as the original drug. This allows for increased competition in the market, potentially leading to lower prices and more options for patients.Rate this question:
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- 13.
Why do pharmaceutical companies need M Squared?
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Because we have sexy employees. I mean, have you checked out Steve Jaben lately?
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Companies have been forced to downsize recently due to the economic downturn and so consultants supply a source of cheap, effective labor.
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Because they are too large to handle finding quality talent on their own.
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Because the requirements and market environment in the industry are so compex, pharma companies need the support of vendors who are dedicated to the industry and are well versed in its intricacies.
Correct Answer
A. Because the requirements and market environment in the industry are so compex, pharma companies need the support of vendors who are dedicated to the industry and are well versed in its intricacies.Explanation
Pharmaceutical companies need M Squared because the requirements and market environment in the industry are complex. M Squared is a vendor that is dedicated to the industry and well versed in its intricacies, providing the necessary support to navigate these complexities.Rate this question:
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- 14.
A drug with "blockbuster" status typically refers to:
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A drug with sales over $1 billion annually
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A drug with more than several hundred million dollars in sales annually
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A drug that is first to market in a novel therapeutic area
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A drug with over $100 million in investment
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A drug sold through video retail chains
Correct Answer
A. A drug with sales over $1 billion annuallyExplanation
A drug with "blockbuster" status typically refers to a drug that has sales over $1 billion annually. This means that the drug is extremely successful and generates significant revenue for the company that produces it. It is considered a blockbuster because it exceeds the expectations and sales of most other drugs on the market.Rate this question:
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- 15.
What unique regulatory framework has evolved in the pharmaceutical industry?
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Country specific regulatory requirements
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Industry-wide guidelines with input from relevant regulatory bodies
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A combination of active company and industry self-regulation with governmentally enforced standards
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Ethical guidelines for physicians adopted by pharmaceutical companies
Correct Answer
A. A combination of active company and industry self-regulation with governmentally enforced standardsExplanation
The unique regulatory framework that has evolved in the pharmaceutical industry is a combination of active company and industry self-regulation with governmentally enforced standards. This means that pharmaceutical companies and the industry as a whole have their own set of regulations and guidelines that they follow to ensure the safety and efficacy of their products. These regulations are enforced by the government to ensure compliance and protect public health. This combination of self-regulation and government enforcement helps to maintain high standards in the pharmaceutical industry.Rate this question:
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- 16.
Most pharmaceutical firms maintain several internal "watchdog" departments to oversee compliance of all functions with internal policies and regulatory mandates. Name one as listed in the book.
Correct Answer
Regulatory Affairs
QA/QC
Legal
ComplianceExplanation
The correct answer is Regulatory Affairs, QA/QC, Legal, Compliance. These departments are responsible for ensuring that all functions within the pharmaceutical firm comply with internal policies and regulatory mandates. Regulatory Affairs focuses on ensuring compliance with government regulations and guidelines, QA/QC oversees quality control processes, Legal handles legal matters and compliance ensures adherence to internal policies and external regulations.Rate this question:
- 17.
What does the acronym CRO stand for? (Use exact words for credit)
Correct Answer
Contract Research Organization
clinical research organizationExplanation
The acronym CRO stands for Contract Research Organization and clinical research organization. These organizations are involved in conducting research on behalf of pharmaceutical, biotechnology, and medical device companies. They provide services such as clinical trials, data management, regulatory support, and quality assurance to ensure the safety and efficacy of new drugs and medical treatments.Rate this question:
- 18.
What does the acronym CSO stand for? (Use exact words for credit)
Correct Answer
Contract Sales OrganizationExplanation
CSO stands for Contract Sales Organization. A Contract Sales Organization is a company that provides sales and marketing services to other businesses on a contractual basis. It helps organizations to outsource their sales activities and focus on their core competencies. By partnering with a CSO, companies can benefit from the expertise and resources of the organization to enhance their sales performance and achieve their business objectives.Rate this question:
- 19.
What does the acronym CMO stand for? (Use exact words for credit)
Correct Answer
Contract Manufacturing OrganizationExplanation
The acronym CMO stands for Contract Manufacturing Organization. This refers to a company that is hired by another company to produce goods or provide manufacturing services on their behalf. The CMO takes care of the entire manufacturing process, from sourcing raw materials to producing the final product. This allows the hiring company to focus on other aspects of their business, such as marketing and distribution.Rate this question:
- 20.
The US accounts for roughly _______ of the world's pharmaceutical revenues
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One quarter
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One half
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Three quarters
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80%
Correct Answer
A. One halfExplanation
The correct answer is "one half." This means that the US accounts for approximately 50% of the world's pharmaceutical revenues. This suggests that the pharmaceutical industry in the US is a significant contributor to the global market, indicating its dominance and importance in terms of revenue generation.Rate this question:
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- 21.
What is the second largest world market for pharmaceuticals?
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Japan
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Western Europe
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Eastern Europe
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Asia
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China
Correct Answer
A. Western EuropeExplanation
Western Europe is the second largest world market for pharmaceuticals because it is home to several major pharmaceutical companies and has a large population with high healthcare spending. The region also has advanced healthcare infrastructure and a strong regulatory framework, which makes it an attractive market for pharmaceutical companies to invest in. Additionally, Western Europe has a high demand for innovative and specialized drugs, contributing to its position as the second largest market for pharmaceuticals globally.Rate this question:
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- 22.
Why would a small innovative company partner with a large pharma company by giving them access to their promising chemicals and molecules? (check all that apply)
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To obtain funding
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To obtain expertise
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To exploit the product's full market potential
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To avoid regulatory burdens
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To expand their product portfolio
Correct Answer(s)
A. To obtain funding
A. To obtain expertise
A. To exploit the product's full market potentialExplanation
A small innovative company may partner with a large pharma company to obtain funding, as the large company may have the financial resources to invest in the development and commercialization of the promising chemicals and molecules. Additionally, partnering with a large pharma company can provide access to expertise, such as scientific knowledge, regulatory guidance, and commercialization strategies, which the small company may lack. Lastly, partnering with a large pharma company can help the small company exploit the product's full market potential, as the large company may have an established distribution network and marketing capabilities.Rate this question:
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- 23.
L be What is another name for unpatented drugs with the same active ingredient and equivalent efficacy as a patented drug?
Correct Answer(s)
generic
generics
generic drug
generic drugsExplanation
The correct answer is "generic, generics, generic drug, generic drugs". Generic drugs are unpatented drugs that contain the same active ingredient and have equivalent efficacy as a patented drug. They are typically cheaper than the brand-name version and are approved by regulatory authorities after the patent for the original drug expires.Rate this question:
- 24.
Most major activities of full-service pharmaceutical companies can be divided into three functional categories. These three "core functions" are:
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1. Research and Development, 2. Manufacturing and Operations, 3. Marketing and Sales.
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1. Research and Development, 2. Business Development, 3. Marketing and Sales
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1. Regulatory, 2. Manufacturing and Operations, 3. Business Development
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Marketing and Sales, 2. Corporate and Administrative, 3. Research and Development
Correct Answer
A. 1. Research and Development, 2. Manufacturing and Operations, 3. Marketing and Sales.Explanation
The correct answer is 1. Research and Development, 2. Manufacturing and Operations, 3. Marketing and Sales. This answer accurately identifies the three core functions of full-service pharmaceutical companies. Research and Development involves the discovery and development of new drugs and therapies. Manufacturing and Operations involve the production and distribution of pharmaceutical products. Marketing and Sales involve promoting and selling these products to healthcare providers and consumers.Rate this question:
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- 25.
What are the 4 common organizations with which Pharma companies often partner or outsource to?
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HMO, PPO, HSA, CRAP
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CMO, CRO, CBO, CDO
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FDA, DEA, CBA, ADA
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CSO, CRO, CPO, CMO
Correct Answer
A. CSO, CRO, CPO, CMOExplanation
Pharma companies often partner or outsource to CSO (Contract Sales Organization), CRO (Contract Research Organization), CPO (Contract Packaging Organization), and CMO (Contract Manufacturing Organization). These organizations provide specialized services and expertise in sales, research, packaging, and manufacturing respectively, allowing pharma companies to focus on their core competencies while leveraging the capabilities of these partners.Rate this question:
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Current Version
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Mar 22, 2023Quiz Edited by
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Jan 12, 2009Quiz Created by
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