Chapter 6 - Medical Affairs
Because without medical affairs, life in Pharma would be pretty boring.
- 1.
Medical Affairs often serves as the internal ___________ between the research and commercial sides of a pharma company.
- A.
Obstacle
- B.
Bridge
- C.
Road
- D.
Hurdle
Correct Answer
B. BridgeExplanation
Medical Affairs often serves as the internal bridge between the research and commercial sides of a pharma company. This means that Medical Affairs plays a crucial role in connecting and facilitating communication and collaboration between these two important departments within the company. They help bridge the gap and ensure that the research findings and insights are effectively translated into commercial strategies and decisions. This collaboration is essential for the successful development and commercialization of pharmaceutical products.Rate this question:
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- 2.
Which consideration (question) is NOT a driver for medical affairs activities?
- A.
What services will generate the maximum amount of profits in the long run based on the company's current level of penetration of a specific therapeutic area.
- B.
What services are of high value, given the degree of innovation represented by company products, the cost and complexity of care regimens, and the nature of the target disease states?
- C.
What services can products in the portfolio "afford", given the revenue potential?
- D.
What services does the company have the internal capabilities to execute effectively?
Correct Answer
A. What services will generate the maximum amount of profits in the long run based on the company's current level of penetration of a specific therapeutic area.Explanation
The question is asking for a consideration that is NOT a driver for medical affairs activities. The correct answer is "What services will generate the maximum amount of profits in the long run based on the company's current level of penetration of a specific therapeutic area." This consideration is not a driver for medical affairs activities because medical affairs activities are primarily focused on providing scientific and medical support, education, and communication to healthcare professionals and stakeholders. While profitability is important for a company, it is not the primary focus of medical affairs activities.Rate this question:
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- 3.
What is the primary purpose of the medical information center?
- A.
Responding to customer concerns, specifically dosing information
- B.
Responding to calls from healthcare professionals, specifically product related inquiries.
- C.
Responding to internal concerns regarding specific products
- D.
Providing medical information to the external community
Correct Answer
B. Responding to calls from healthcare professionals, specifically product related inquiries.Explanation
The primary purpose of the medical information center is to respond to calls from healthcare professionals, specifically regarding product related inquiries. This means that the center is responsible for providing information and guidance to healthcare professionals who have questions or concerns about specific products. They may provide information about dosing, usage, side effects, or any other product-related inquiries that healthcare professionals may have. The center is not primarily focused on responding to customer concerns or internal concerns, but rather on serving the needs of healthcare professionals.Rate this question:
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- 4.
What is not required by Medical Affairs to ensure that information disseminated by the Medical Information Center is clear and accurate?
- A.
Standardized operating procedures
- B.
Experience with the development of the product
- C.
Robust systems and tools
- D.
Intensive training
Correct Answer
B. Experience with the development of the productExplanation
Experience with the development of the product is not required by Medical Affairs to ensure that information disseminated by the Medical Information Center is clear and accurate. While experience with the product development can provide valuable insights, it is not a necessary requirement for ensuring the clarity and accuracy of the information. Instead, standardized operating procedures, robust systems and tools, and intensive training are more important in ensuring that the information is clear and accurate. These factors help in establishing consistent processes, reliable systems, and well-trained staff to handle medical information effectively.Rate this question:
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- 5.
What role does Pharmacovigilance play in Medical Affairs?
- A.
The Robin Hoods of the Pharma world.
- B.
Dealing with negligent behavior during clinical drug trials.
- C.
Dealing with the enforcement of restrictions by the FDA during clinical trials.
- D.
Dealing with reports of adverse events in patients during clinical trials.
Correct Answer
D. Dealing with reports of adverse events in patients during clinical trials.Explanation
Pharmacovigilance plays a crucial role in Medical Affairs by dealing with reports of adverse events in patients during clinical trials. This involves monitoring and evaluating the safety of pharmaceutical products, identifying and assessing potential risks, and taking appropriate measures to ensure patient safety. Pharmacovigilance aims to detect, assess, understand, and prevent adverse effects or any other drug-related problems, contributing to the overall benefit-risk assessment of medications. By actively monitoring and reporting adverse events, Pharmacovigilance helps in improving patient care, ensuring drug safety, and making informed decisions regarding the use of pharmaceutical products.Rate this question:
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- 6.
What is the role of Medical Affairs in Preclinical Research?
- A.
Medical Affairs controls all Preclinical Research
- B.
Medical Affairs provides value perspective/vision based on its understanding of alternative products and unmet medical needs
- C.
Medical Affairs acts as the liaison between the Regulatory Department and the Discovery team to ensure that the two divisions are working together to meet the strategic needs of the company.
- D.
Medical Affairs plays no role in Preclinical Research.
Correct Answer
B. Medical Affairs provides value perspective/vision based on its understanding of alternative products and unmet medical needsExplanation
Medical Affairs plays a crucial role in Preclinical Research by providing a value perspective and vision based on its understanding of alternative products and unmet medical needs. This means that they contribute to the decision-making process by evaluating the potential value and impact of the research in relation to other available products and the current medical needs. Their input helps guide the direction and focus of the research, ensuring that it aligns with the company's strategic goals and addresses important medical gaps.Rate this question:
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- 7.
What role does Medial Affairs play in registrational clinical trials?
- A.
Medical Affairs is consulted when the trial is moving between the phases to provide strategic planning advice.
- B.
Medical Affairs is in charge of everything related to registrational clinical trials.
- C.
Medical Affairs plays no role in registrational clinical trials.
- D.
Limited primarily to the recruitment of trial investigators.
Correct Answer
D. Limited primarily to the recruitment of trial investigators. -
- 8.
What role does Medical Affairs typically have in non-registrational clinical trials?
- A.
Medical Affairs plays no role in non-registrational clinical trials.
- B.
Medical Affairs assumes responsibility for all post approval studies.
- C.
Medical Affairs plays a limited governance role in post approval trials.
- D.
Medical Affairs is on-call and provides assistance when necessary in post approval trials.
Correct Answer
B. Medical Affairs assumes responsibility for all post approval studies.Explanation
Medical Affairs typically assumes responsibility for all post approval studies, which includes non-registrational clinical trials. They are involved in designing, conducting, and monitoring these trials to gather additional data on the safety and efficacy of the approved medication or treatment. Medical Affairs also ensures compliance with regulatory requirements and provides support to investigators and study sites throughout the trial process.Rate this question:
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- 9.
What are Phase IIIb trials?
- A.
Studies that are a necessary component of the application for regulatory approval.
- B.
Additional studies that piggy back onto the normal phase 3 trials that cropped up due to significant reports of adverse events.
- C.
Studies conducted after a submission to regulators for marketing approval but before that approval is actually granted.
- D.
Phase 3 studies that are being repeated due to the discovery on an off-label usage of the product.
Correct Answer
C. Studies conducted after a submission to regulators for marketing approval but before that approval is actually granted.Explanation
Phase IIIb trials are studies conducted after a submission to regulators for marketing approval but before that approval is actually granted. These trials are conducted to gather additional data on the safety, efficacy, and optimal use of a drug or medical device. They provide further evidence of the product's benefits and risks, and help regulators make informed decisions regarding its approval. These trials are important in ensuring the safety and effectiveness of the product before it is made available to the general public.Rate this question:
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- 10.
Which is NOT a reason to conduct non-registrational trials?
- A.
To increase local market presence and experience
- B.
To evaluate product use in a variety of "real-world" settings
- C.
To evaluate off-label usage of the product
- D.
To enhance product differentiation
- E.
To gather additional safety information
Correct Answer
C. To evaluate off-label usage of the productExplanation
Non-registrational trials are conducted for various reasons, such as increasing local market presence and experience, evaluating product use in real-world settings, enhancing product differentiation, and gathering additional safety information. However, evaluating off-label usage of the product is not a reason to conduct these trials. Off-label usage refers to the use of a drug or medical device for a purpose not approved by regulatory authorities. While off-label usage may be explored in other types of studies, non-registrational trials typically focus on other objectives.Rate this question:
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- 11.
True or False: The term "off-label' can encompass any change to regulator-approved language regarding use of a product up to the examination of an entirely new indication.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The term "off-label" refers to the use of a medication or medical device for a purpose that has not been approved by regulatory authorities. This can include any change to the approved language regarding the use of a product, ranging from minor modifications to completely new indications. Therefore, the statement that "off-label" can encompass any change to regulator-approved language regarding use of a product up to the examination of an entirely new indication is true.Rate this question:
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- 12.
True or false: In the event an "off-label" study seems promising, Medical Affairs usually assumes responsibility of the necessary Phase 2 and 3 clinical studies required for approval of that off label usage.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
Medical Affairs does not assume responsibility for conducting Phase 2 and 3 clinical studies required for approval of off-label usage. The responsibility for conducting these studies lies with the pharmaceutical company or the sponsor of the study. Medical Affairs may provide support and guidance in terms of scientific and medical expertise, but they do not take on the responsibility of conducting the clinical studies.Rate this question:
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- 13.
True or False: Companies are required to market/promote the information gathered during off label non-registrational trials when it becomes available.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
Companies are not required to market or promote the information gathered during off-label non-registrational trials when it becomes available. Off-label use refers to the use of a drug for a purpose not approved by regulatory authorities. Non-registrational trials are conducted to gather additional data on the safety and efficacy of a drug. While companies may choose to share this information with healthcare professionals or the scientific community, there is no legal obligation to market or promote it to the public. Therefore, the statement is false.Rate this question:
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- 14.
Why can't the company who created the initial product be involved in any way in the actual conduct of an investigator-initiated trial?
- A.
The conclusions drawn from the trial must be the independent judgment of the investigating physicians.
- B.
Affiliation with the company who created the product would bias the reputation of the study.
- C.
The company is only allowed to be involved with the actual conduct of the trial if they are supplying the test material.
- D.
A and C
- E.
B and C
Correct Answer
A. The conclusions drawn from the trial must be the independent judgment of the investigating physicians.Explanation
The company who created the initial product cannot be involved in any way in the actual conduct of an investigator-initiated trial because the conclusions drawn from the trial must be the independent judgment of the investigating physicians. If the company were involved, it could introduce bias and compromise the integrity of the study. The independence of the investigating physicians ensures that the trial results are objective and reliable.Rate this question:
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- 15.
What is an investigator-initiated trial?
- A.
A type of phase 4 clinical trial.
- B.
A company-sponsored study.
- C.
A study to investigate a new application of an approved drug without submission of an IND.
- D.
A study regarding a different use of the product conducted by a competitor under the approval of the original product owner.
Correct Answer
A. A type of phase 4 clinical trial.Explanation
An investigator-initiated trial refers to a type of phase 4 clinical trial. Phase 4 trials are conducted after a drug has been approved and made available to the public. These trials are initiated by independent investigators, usually researchers or physicians, who propose and conduct the study. Unlike company-sponsored studies, investigator-initiated trials are not funded or controlled by pharmaceutical companies. Instead, they are driven by the curiosity and expertise of the investigators who aim to explore new applications or evaluate the effectiveness and safety of approved drugs in real-world settings.Rate this question:
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- 16.
What is the name for the studies Medical Affairs performs involving financial and quality of life impacts of a disease; the limitations of other therapies, including the existing standard of care; and the different characteristics of a company product in terms of cost and patient outcomes?
- A.
Pharmacoeconomics
- B.
Pharmacovigilance
- C.
Health economics and outcomes studies
- D.
Cost-benefit ratio in financial terms
Correct Answer
C. Health economics and outcomes studiesExplanation
Health economics and outcomes studies refer to the studies conducted by Medical Affairs to assess the financial and quality of life impacts of a disease, the limitations of other therapies, including the existing standard of care, and the different characteristics of a company product in terms of cost and patient outcomes. These studies help in evaluating the economic value and effectiveness of a treatment or intervention, providing valuable information for decision-making in healthcare. Pharmacoeconomics focuses specifically on the economic evaluation of pharmaceutical products, while pharmacovigilance deals with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Cost-benefit ratio in financial terms is a general concept used to assess the financial viability of an intervention or investment.Rate this question:
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- 17.
How does Medical Affairs impact product messaging?
- A.
Medical Affairs has nothing to do with product messaging.
- B.
Medical Affairs is in charge of product messaging.
- C.
Medical Affairs can impact the brand messaging by offering medical and scientific insights.
- D.
Medical Affairs defines the promotional product messages.
Correct Answer
C. Medical Affairs can impact the brand messaging by offering medical and scientific insights.Explanation
Medical Affairs can impact the brand messaging by offering medical and scientific insights. This is because Medical Affairs teams are responsible for ensuring that the messaging around a product is accurate, scientifically sound, and compliant with regulatory guidelines. They provide medical and scientific expertise to help shape the messaging and ensure that it effectively communicates the value and benefits of the product to healthcare professionals and patients. By offering these insights, Medical Affairs can play a crucial role in shaping the brand messaging and ensuring its credibility and effectiveness.Rate this question:
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- 18.
Which is NOT a consideration that would normally be addressed in outcomes studies?
- A.
Incidence and intensity of adverse effects
- B.
Adherence to the recommended drug regimen.
- C.
What the cost-benefit equation is in financial terms.
- D.
Overall quality of life.
Correct Answer
C. What the cost-benefit equation is in financial terms.Explanation
In outcomes studies, various factors are typically considered to evaluate the effectiveness of a treatment or intervention. These include the incidence and intensity of adverse effects, adherence to the recommended drug regimen, and overall quality of life. However, the consideration of what the cost-benefit equation is in financial terms is not typically addressed in outcomes studies. This is because outcomes studies primarily focus on the clinical outcomes and patient-related outcomes rather than the financial implications of the treatment.Rate this question:
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- 19.
Within Medical Affairs, what is the role of Medical Communications?
- A.
Medical Communications is responsible for disseminating information that supports the positive outcomes of the company's products.
- B.
Medical Communications acts as a relay center between Medical Affairs and the outside world, performing triage and routing calls from healthcare professionals and patients.
- C.
Medical Communications is responsible for the brand messaging and marketing materials for a new product.
- D.
Medical Communications is responsible for communicating unbiased non-promotional information the company's products.
Correct Answer
D. Medical Communications is responsible for communicating unbiased non-promotional information the company's products.Explanation
Medical Communications is responsible for communicating unbiased non-promotional information about the company's products. This means that their role is to provide accurate and balanced information to healthcare professionals, patients, and the public, without any promotional bias. They act as a reliable source of information, ensuring that the dissemination of information is accurate and evidence-based. Their goal is to educate and inform rather than promote the company's products, ultimately supporting the transparency and integrity of the organization.Rate this question:
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- 20.
What is the primary matter addressed by Publication Planning?
- A.
How to brand and market a new product.
- B.
Determining when and where to publish information about a product.
- C.
When articles are published about a product, how to use the peer-reviewed literature to the advantage of a drug.
- D.
The overall plan of the NDA application submitted to the FDA.
Correct Answer
B. Determining when and where to publish information about a product.Explanation
Publication planning primarily addresses the process of determining when and where to publish information about a product. This involves strategically planning the timing and location of publications to maximize the product's exposure and reach the target audience effectively. It includes identifying suitable journals, conferences, and other platforms for dissemination, considering factors such as the product's stage of development, target market, and key messages. By carefully planning the publication of information, companies can ensure that their product receives the desired attention and recognition in the scientific community and among potential customers.Rate this question:
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- 21.
What piece of material do the Medical Writers NOT play a role in creating?
- A.
The package insert.
- B.
Journal articles.
- C.
Summaries of published articles, or abstracts.
- D.
Oversized summaries of preliminary trial results, or posters.
Correct Answer
A. The package insert.Explanation
Medical writers play a role in creating journal articles, summaries of published articles, and oversized summaries of preliminary trial results. However, they do not play a role in creating the package insert. The package insert is typically created by regulatory affairs professionals or medical affairs teams, who compile information about the drug or medical device, including its indications, contraindications, dosing instructions, and safety information. Medical writers may provide input or review the package insert for accuracy and clarity, but they are not primarily responsible for its creation.Rate this question:
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- 22.
Why is it important for a pharma company to enlist the expertise of KOLs in the development of a new drug?
- A.
The KOL's are plugged into the industry and understand where gaps are for the pharma company to exploit.
- B.
The opinion of a KOL carries much weight with the community and can influence healthcare officials with prescribing power around them.
- C.
KOL's will be more apt to prescribe a drug that they helped develop.
- D.
Pharma companies can use the expertise of KOL's to help refine their lead series to formulate a more promising compound.
Correct Answer
B. The opinion of a KOL carries much weight with the community and can influence healthcare officials with prescribing power around them.Explanation
Enlisting the expertise of Key Opinion Leaders (KOLs) in the development of a new drug is important because their opinions carry significant influence within the medical community. KOLs have a deep understanding of the industry and can identify gaps that the pharma company can exploit. Their endorsement of a drug can sway healthcare officials with prescribing power to support its use. Additionally, KOLs are more likely to prescribe a drug they helped develop, which can lead to increased adoption and success in the market. Therefore, involving KOLs in the drug development process can enhance the drug's credibility, market potential, and overall success.Rate this question:
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- 23.
Who, within Medical Affairs, is responsible for cultivating long term relationships with external KOL's?
- A.
The head of Medical Affairs
- B.
The most famous/prominent scientists on staff at the particular pharma company.
- C.
The Medical Liaison
- D.
Internal KOL's
Correct Answer
C. The Medical LiaisonExplanation
The Medical Liaison is responsible for cultivating long-term relationships with external Key Opinion Leaders (KOLs) within Medical Affairs. They act as a bridge between the company and the KOLs, providing scientific and medical information, building trust, and establishing collaborative partnerships. The Medical Liaison plays a crucial role in understanding the needs and perspectives of the KOLs, representing the company's interests, and ensuring effective communication and engagement with external stakeholders.Rate this question:
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- 24.
Which is NOT a primary reason that KOL's important to pharma companies?
- A.
KOL's may educate fellow physicians about therapeutic options they consider the best.
- B.
KOL's can offer insights into treatment issues and unmet needs inside the therapeutic area.
- C.
KOL's may provide disease-state education to their fellow physicians/build awareness
- D.
KOL's run the external continuing education programs as a representative of the sponsoring pharma company.
- E.
KOL's may agree to serve as investigators on clinical trials thereby increasing the impact of such trials on the perception of other healthcare professionals.
Correct Answer
D. KOL's run the external continuing education programs as a representative of the sponsoring pharma company.Explanation
KOL's are important to pharma companies because they can educate fellow physicians about therapeutic options, offer insights into treatment issues and unmet needs, provide disease-state education, and serve as investigators on clinical trials. However, the statement that KOL's run the external continuing education programs as a representative of the sponsoring pharma company is not a primary reason for their importance.Rate this question:
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- 25.
What makes a Medical Liaison successful in securing access to KOL's and AMC's (Academic Medical Centers)
- A.
A large supply of alcohol, hot girls, money, and other niceties that are good to have on hand when trying to influence KOLs.
- B.
A smooth, sales-guy persona who can sell ice to an eskimo.
- C.
Their access to the board of governors at the target AMC to influence the prescribing physicians from the top down.
- D.
Their demonstrated mastery of the latest research related to a therapeutic area, disease state, and drug.
Correct Answer
D. Their demonstrated mastery of the latest research related to a therapeutic area, disease state, and drug.Explanation
The correct answer is "Their demonstrated mastery of the latest research related to a therapeutic area, disease state, and drug." This answer suggests that a Medical Liaison's success in securing access to KOLs and AMC's is based on their knowledge and expertise in the specific field of medicine. By having a deep understanding of the latest research, they can effectively communicate and engage with key opinion leaders and academic medical centers, establishing credibility and trust. This expertise allows them to provide valuable insights and support to healthcare professionals, ultimately influencing prescribing decisions.Rate this question:
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- 26.
The internal training run by Medical Affairs is largely limited to:
- A.
Education of members within the function in question, enforcing the scientific knowledge and communication skills necessary to their roles.
- B.
Cross-educational seminars to increase the overall scientific and industry awareness within a company.
- C.
Only those who have an external facing role to enhance their ability to translate internal knowledge to the outside world.
- D.
Medical Affairs is not affiliated with internal training in any way.
Correct Answer
A. Education of members within the function in question, enforcing the scientific knowledge and communication skills necessary to their roles.Explanation
The internal training run by Medical Affairs focuses on educating members within the function in question and enforcing the scientific knowledge and communication skills necessary for their roles. This training is specifically tailored to enhance the abilities of members within Medical Affairs and ensure they have the necessary skills to perform their duties effectively. It does not involve cross-educational seminars or training for those with external facing roles. Medical Affairs is actively involved in internal training and plays a crucial role in educating and developing its members.Rate this question:
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- 27.
What is a risk that is NOT addressed by formalized standards of maintaining the separation of scientific discourse from commercial objectives at external education programs?
- A.
Sales and marketing teams may make aggressive attempts to promote company products as these events.
- B.
Commercial considerations may bias the content of presentations at these events.
- C.
Prescribers may receive improper incentives to change their prescribing behavior.
- D.
The publication of literature regarding a scientific breakthrough that has potentially rippling effects within the industry
Correct Answer
D. The publication of literature regarding a scientific breakthrough that has potentially rippling effects within the industryExplanation
The risk that is not addressed by formalized standards of maintaining the separation of scientific discourse from commercial objectives at external education programs is the publication of literature regarding a scientific breakthrough that has potentially rippling effects within the industry. This risk refers to the possibility of scientific research being influenced or manipulated by commercial interests, leading to biased or inaccurate information being disseminated to the public. Formalized standards aim to prevent sales and marketing teams from promoting company products aggressively, biasing the content of presentations, and providing improper incentives to prescribers, but they may not specifically address the risk of publication bias or manipulation of scientific breakthroughs.Rate this question:
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- 28.
Why does the Medical Affairs budget and reporting relationship usually come under Drug Discovery and not Marketing?
- A.
Because the marketing budget is already a large proportion of total expenditures due to aggressive direct-to-consumer advertising.
- B.
Because drug discovery is the most important division of a R&D based pharma company.
- C.
Because drug discovery must be aligned at the very beginning with the strategic goals of the company.
- D.
Because increasing regulatory scrutiny showed the need for a separation of educational and commercial activities.
Correct Answer
D. Because increasing regulatory scrutiny showed the need for a separation of educational and commercial activities.Explanation
The reason why the Medical Affairs budget and reporting relationship usually come under Drug Discovery and not Marketing is because increasing regulatory scrutiny showed the need for a separation of educational and commercial activities. This means that there is a growing demand for a clear distinction between the educational aspects of medical affairs and the commercial aspects of marketing. This separation helps to ensure that medical information is provided objectively and independently, without any potential bias or influence from marketing activities.Rate this question:
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- 29.
What is NOT one of the three major divisions (broad groups) of a full-service Medical Affairs team?
- A.
Medical Services
- B.
Medical Communications
- C.
Medical or Science Liaisons
- D.
Medical Research
Correct Answer
B. Medical CommunicationsExplanation
Medical Communications is not one of the three major divisions of a full-service Medical Affairs team. The three major divisions typically include Medical Services, Medical or Science Liaisons, and Medical Research. Medical Communications, on the other hand, refers to the department responsible for creating and disseminating medical information to various stakeholders, including healthcare professionals, patients, and the general public. While it is an important function within a healthcare organization, it is not considered one of the core divisions of a full-service Medical Affairs team.Rate this question:
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