WK 8 DQ 1
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Operating Margins" Please respond to the following:
- Imagine you work for a hospital where the operating margins have been
consistently below national norms for the past three (3) years. Discuss one (1)
key driver of the below average performance. Suggest one (1) strategy to improve
the future management of the driver that you’ve discussed. - Suppose you work for a hospital that was denied a contract with an HMO last
year. Legal counsel believes there was a breach of contract and wishes to bring
suit against the HMO for damages. The chief executive officer has asked you to
work with the controller to develop a defensible measure of the damages
experienced during the last year. Create an argument for the reimbursement of
damages in which you indicate the denial’s resulting impact to patient care.
Provide support for your argument.
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MBchB study guide
Abnormal uterine bleeding includes abnormal menstrual bleeding and bleeding due to other causes such as pregnancy, systemi ...
MBchB study guide
Abnormal uterine bleeding includes abnormal menstrual bleeding and bleeding due to other causes such as pregnancy, systemic disease, or cancer.
RGA 6212 Northeastern University Week 3 Drug Approval Package Pharmacology Question
ASSIGNMENT AVAILABLE: Week 3ASSIGNMENT DUE: ASSIGNMENT LENGTH:o 5-7 written pages including references but NOT Including ...
RGA 6212 Northeastern University Week 3 Drug Approval Package Pharmacology Question
ASSIGNMENT AVAILABLE: Week 3ASSIGNMENT DUE: ASSIGNMENT LENGTH:o 5-7 written pages including references but NOT Including figures or tables, double- spacedDELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #1Assignment description:In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:Demonstrate an understanding of the basic principles of what encompasses safety science with respect to drug/biologics developmentDemonstrate an ability to extract and interpret safety-relevant information form the publicly available FDA Drug Approval Package InformationDemonstrate an ability to describe/analyze safety information for an approved drug/biologic/deviceFor this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new, inhaled treatment for Parkinson’s Disease. Your company is very small and inexperienced and so far, none of the nonclinical safety testing or clinical testing of this new drug has begun. As your team members prepare to start nonclinical safety testing and then clinical testing of the drug, it is your task to provide your colleagues with a summary of how nonclinical and clinical data is used to inform the development of safety information about your new Parkinson’s disease drug. You also need to provide your colleagues with background information on the regulatory aspects of safety monitoring, using the safety guidance provided by FDA and ICH.During your research to learn more about drugs that treat Parkinson’s, you discover that there is already a marketed product for Parkinson’s that is also administered by inhaler. The already approved drug is called Inbrija (also known as CVT-301 – the research code name). This is great news! You can use this similar, already-approved drug as a comparison for your investigational inhaled therapeutic for Parkinson’s.There is a lot of information your company can learn about how to safely develop your planned novel Parkinson’s therapeutic by studying the FDA’s published NDA approval information located on the FDA’s database of approved products: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209184Orig1s000TOC.cfm (Links to an external site.). Specifically,you can learn a lot about the safety information that was included in the NDA for Inbrija by reviewing information contained in the following FDA Application review Files:Your task is to provide the following information to your colleagues (incorporation of figures and graphs HIGHLY encouraged):1. Part 1: Background information:Overview of Safety Basics: A description of the basic principles of generating safety information about drugs/biologics (see Module 2/Week 2 Lecture and related materials) from nonclinical and clinical studies that are relevant to a drug’s development. You may wish to include a description of why safety monitoring is a critical component of nonclinical and clinical development of a drug so that your colleagues fully understand the importance.Regulatory information: Describe for your colleagues the different ICH and FDA guidance documents that are available to help you navigate the regulatory requirements with respect to safety monitoring from the nonclinical and clinical development perspectives. The ICH’s M3(R2) (Links to an external site.)(see week 1 reading) is a useful tool that you can describe for your colleagues to help them understand nonclinical safety requirements that must be completed prior to and during clinical testing of the drug. You can also navigate to the FDA’s Safety Reporting requirements for INDs (Links to an external site.)(see week 3 reading) and describe some of the requirements for clinical safety2. Part II: Pulling out relevant examples from the Inbrija FDA approval packageNonclinical safety information: Using the “Pharmacology Review” file for Inbrija’s NDA approval package, describe what kinds of safety pharmacology and general toxicology studies that were run. You can describe the number of studies in each nonclinical safety category as well as what species they were run in and the basic results/findings of these studies. You are encouraged to include tables and figures from the Pharmacology Review in your written summary, just be sure to includeClinical safety information: Using the “Medical Review” file, describe some of the safety information that was generated as part of the clinical trials that were implemented when Inbrija was being developed. You should include a brief list/description of all the clinical trials that werePart III: Conclusions: This section should be at least one paragraph and should work to summarize next steps for your company with respect to developing the nonclinical and clinical safety program for your novel Parkinson’s diseaseWe will review this assignment in weeks 1,2, and 3 and I am available by email to answer any questions you have regarding the assignment.The entire assignment should be 5-7 pages of content (including references). Any graphs or figures that you choose to include must be properly cited and do not count against your page count. Please submit your assignment through the link provided in Canvas. Please remember that this assignment is worth 15.0% of your final grade for the course. Late submissions will not be accepted without prior permission of the Instructor.PreviousNext
NHSFP6004 Capella Activities and Materials Needed for Telehealth Training Paper
Overview Develop a training plan for one of the role groups in the organization that will be responsible for implementing ...
NHSFP6004 Capella Activities and Materials Needed for Telehealth Training Paper
Overview Develop a training plan for one of the role groups in the organization that will be responsible for implementing practice guidelines under the new organizational policy you presented in Assessment 3. Prepare an agenda for a two-hour workshop, and summarize your strategies for working with this group, the expected outcomes of the training, and why you chose this group to pilot the change. Note: Each assessment in this course builds on the work you completed in the previous assessment. Therefore, you must complete the assessments in this course in the order in which they are presented. Training and educating those within an organization who will be responsible for implementing and working with changes in organizational policy is a critical step in ensuring that prescribed changes have their intended benefit. A leader in a health care profession needs to be able to apply effective leadership, management, and educational strategies to ensure that colleagues and subordinates will be prepared to do the work that is asked of them. This assessment offers you an opportunity to develop and implement such strategies. By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria: Competency 2: Analyze relevant health care laws and regulations and their applications and effects on processes within a health care team or organization. Describe changes to policy or practice guidelines to be implemented in an organization. Competency 3: Lead the development and implementation of ethical and culturally sensitive policies that improve health outcomes for individuals, organizations, and populations. Identify training activities and materials that support learning and skill development and prepare a specific group to successfully apply a new policy or practice guidelines to its work. Justify the importance of an institutional policy or practice guidelines to improve the quality of care or outcomes related to a specific group. Competency 5: Develop strategies to work collaboratively with policy makers, stakeholders, and colleagues to address environmental (governmental and regulatory) forces. Develop strategies for engaging with a specific group to ensure buy in, support, and preparedness to implement changes in policy and practice guidelines. Advocate for the importance of the role a specific group will play in implementing changes in policy and practice guidelines. Competency 6: Apply various methods of communicating with policy makers, stakeholders, colleagues, and patients to ensure that communication in a given situation is professional, clear, efficient, and effective. Interpret complex policy considerations or practice guidelines for a specific group with respect and clarity. Write clearly and logically, with correct use of grammar, punctuation, and spelling. Integrate relevant sources to support arguments, correctly formatting citations and references using current APA style.
Chamberlain College Ethical Path of Conduct Religion and Ethics Case Study
InstructionsReview the following ethical dilemmas:John Doe has decided to clone himself. He is sterile. He cannot find any ...
Chamberlain College Ethical Path of Conduct Religion and Ethics Case Study
InstructionsReview the following ethical dilemmas:John Doe has decided to clone himself. He is sterile. He cannot find anyone to marry him. He wishes to have children. He knows that he will not be able to love a child that is adopted or not connected directly to him biologically. He will be making use of a new procedure that involves taking his skin cells to produce a twin. The twin starts out as an embryo and grows into a child. The child in this case will have the same genetic information as John Doe. John Doe and his child will be twins.Jane Doe is eighteen. For as long as she can remember she has been sexually attracted to other females. Her parents belong to a religion that has a religious text stating that God forbids one to be a lesbian. This religion goes on further to say that lesbians will be punished in the afterlife. Jane Doe is debating whether she should tell her parents about her sexual attraction. She has not yet decided if she should come out to her parents and live as a lesbian now that she is a legal adult.Joe and Mary are a couple. Before becoming sterile, they had a child. This child died of a rare disease. Joe and Mary miss their child terribly. They have heard that there is a new IVF procedure that can ensure that they can have another child. However, their religion forbids using IVF. Use the resources assigned for this week and additional research,InstructionsSelect two of the situations above and then address 2 of the following:What is the relation between ethics and religion? Formulate and investigate the relation.For each case, determine the ethical path of conduct. Then, determine what paths of conduct would be unethicalFor each case, what would an emotivism say to appraise what you determine is the ethical form of conduct?For each case, would a natural law ethicist agree with what you say is the ethical form of conduct? Why or why not?Articulate, explain, and evaluate in each case an approach that makes use of divine command ethics.Writing Requirements (APA format)Length: 2-3 pages (not including title page or references page)1-inch marginsDouble spaced12-point Times New Roman fontTitle pageReferences page (minimum of 2 scholarly sources)
9 pages
Strategic Plan For Allina Health
The SWOT analysis conducted in the previous stage revealed several issues currently facing Allina Health Inc. The facility ...
Strategic Plan For Allina Health
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14 pages
MBchB study guide
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RGA 6212 Northeastern University Week 3 Drug Approval Package Pharmacology Question
ASSIGNMENT AVAILABLE: Week 3ASSIGNMENT DUE: ASSIGNMENT LENGTH:o 5-7 written pages including references but NOT Including ...
RGA 6212 Northeastern University Week 3 Drug Approval Package Pharmacology Question
ASSIGNMENT AVAILABLE: Week 3ASSIGNMENT DUE: ASSIGNMENT LENGTH:o 5-7 written pages including references but NOT Including figures or tables, double- spacedDELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #1Assignment description:In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:Demonstrate an understanding of the basic principles of what encompasses safety science with respect to drug/biologics developmentDemonstrate an ability to extract and interpret safety-relevant information form the publicly available FDA Drug Approval Package InformationDemonstrate an ability to describe/analyze safety information for an approved drug/biologic/deviceFor this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new, inhaled treatment for Parkinson’s Disease. Your company is very small and inexperienced and so far, none of the nonclinical safety testing or clinical testing of this new drug has begun. As your team members prepare to start nonclinical safety testing and then clinical testing of the drug, it is your task to provide your colleagues with a summary of how nonclinical and clinical data is used to inform the development of safety information about your new Parkinson’s disease drug. You also need to provide your colleagues with background information on the regulatory aspects of safety monitoring, using the safety guidance provided by FDA and ICH.During your research to learn more about drugs that treat Parkinson’s, you discover that there is already a marketed product for Parkinson’s that is also administered by inhaler. The already approved drug is called Inbrija (also known as CVT-301 – the research code name). This is great news! You can use this similar, already-approved drug as a comparison for your investigational inhaled therapeutic for Parkinson’s.There is a lot of information your company can learn about how to safely develop your planned novel Parkinson’s therapeutic by studying the FDA’s published NDA approval information located on the FDA’s database of approved products: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209184Orig1s000TOC.cfm (Links to an external site.). Specifically,you can learn a lot about the safety information that was included in the NDA for Inbrija by reviewing information contained in the following FDA Application review Files:Your task is to provide the following information to your colleagues (incorporation of figures and graphs HIGHLY encouraged):1. Part 1: Background information:Overview of Safety Basics: A description of the basic principles of generating safety information about drugs/biologics (see Module 2/Week 2 Lecture and related materials) from nonclinical and clinical studies that are relevant to a drug’s development. You may wish to include a description of why safety monitoring is a critical component of nonclinical and clinical development of a drug so that your colleagues fully understand the importance.Regulatory information: Describe for your colleagues the different ICH and FDA guidance documents that are available to help you navigate the regulatory requirements with respect to safety monitoring from the nonclinical and clinical development perspectives. The ICH’s M3(R2) (Links to an external site.)(see week 1 reading) is a useful tool that you can describe for your colleagues to help them understand nonclinical safety requirements that must be completed prior to and during clinical testing of the drug. You can also navigate to the FDA’s Safety Reporting requirements for INDs (Links to an external site.)(see week 3 reading) and describe some of the requirements for clinical safety2. Part II: Pulling out relevant examples from the Inbrija FDA approval packageNonclinical safety information: Using the “Pharmacology Review” file for Inbrija’s NDA approval package, describe what kinds of safety pharmacology and general toxicology studies that were run. You can describe the number of studies in each nonclinical safety category as well as what species they were run in and the basic results/findings of these studies. You are encouraged to include tables and figures from the Pharmacology Review in your written summary, just be sure to includeClinical safety information: Using the “Medical Review” file, describe some of the safety information that was generated as part of the clinical trials that were implemented when Inbrija was being developed. You should include a brief list/description of all the clinical trials that werePart III: Conclusions: This section should be at least one paragraph and should work to summarize next steps for your company with respect to developing the nonclinical and clinical safety program for your novel Parkinson’s diseaseWe will review this assignment in weeks 1,2, and 3 and I am available by email to answer any questions you have regarding the assignment.The entire assignment should be 5-7 pages of content (including references). Any graphs or figures that you choose to include must be properly cited and do not count against your page count. Please submit your assignment through the link provided in Canvas. Please remember that this assignment is worth 15.0% of your final grade for the course. Late submissions will not be accepted without prior permission of the Instructor.PreviousNext
NHSFP6004 Capella Activities and Materials Needed for Telehealth Training Paper
Overview Develop a training plan for one of the role groups in the organization that will be responsible for implementing ...
NHSFP6004 Capella Activities and Materials Needed for Telehealth Training Paper
Overview Develop a training plan for one of the role groups in the organization that will be responsible for implementing practice guidelines under the new organizational policy you presented in Assessment 3. Prepare an agenda for a two-hour workshop, and summarize your strategies for working with this group, the expected outcomes of the training, and why you chose this group to pilot the change. Note: Each assessment in this course builds on the work you completed in the previous assessment. Therefore, you must complete the assessments in this course in the order in which they are presented. Training and educating those within an organization who will be responsible for implementing and working with changes in organizational policy is a critical step in ensuring that prescribed changes have their intended benefit. A leader in a health care profession needs to be able to apply effective leadership, management, and educational strategies to ensure that colleagues and subordinates will be prepared to do the work that is asked of them. This assessment offers you an opportunity to develop and implement such strategies. By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and assessment criteria: Competency 2: Analyze relevant health care laws and regulations and their applications and effects on processes within a health care team or organization. Describe changes to policy or practice guidelines to be implemented in an organization. Competency 3: Lead the development and implementation of ethical and culturally sensitive policies that improve health outcomes for individuals, organizations, and populations. Identify training activities and materials that support learning and skill development and prepare a specific group to successfully apply a new policy or practice guidelines to its work. Justify the importance of an institutional policy or practice guidelines to improve the quality of care or outcomes related to a specific group. Competency 5: Develop strategies to work collaboratively with policy makers, stakeholders, and colleagues to address environmental (governmental and regulatory) forces. Develop strategies for engaging with a specific group to ensure buy in, support, and preparedness to implement changes in policy and practice guidelines. Advocate for the importance of the role a specific group will play in implementing changes in policy and practice guidelines. Competency 6: Apply various methods of communicating with policy makers, stakeholders, colleagues, and patients to ensure that communication in a given situation is professional, clear, efficient, and effective. Interpret complex policy considerations or practice guidelines for a specific group with respect and clarity. Write clearly and logically, with correct use of grammar, punctuation, and spelling. Integrate relevant sources to support arguments, correctly formatting citations and references using current APA style.
Chamberlain College Ethical Path of Conduct Religion and Ethics Case Study
InstructionsReview the following ethical dilemmas:John Doe has decided to clone himself. He is sterile. He cannot find any ...
Chamberlain College Ethical Path of Conduct Religion and Ethics Case Study
InstructionsReview the following ethical dilemmas:John Doe has decided to clone himself. He is sterile. He cannot find anyone to marry him. He wishes to have children. He knows that he will not be able to love a child that is adopted or not connected directly to him biologically. He will be making use of a new procedure that involves taking his skin cells to produce a twin. The twin starts out as an embryo and grows into a child. The child in this case will have the same genetic information as John Doe. John Doe and his child will be twins.Jane Doe is eighteen. For as long as she can remember she has been sexually attracted to other females. Her parents belong to a religion that has a religious text stating that God forbids one to be a lesbian. This religion goes on further to say that lesbians will be punished in the afterlife. Jane Doe is debating whether she should tell her parents about her sexual attraction. She has not yet decided if she should come out to her parents and live as a lesbian now that she is a legal adult.Joe and Mary are a couple. Before becoming sterile, they had a child. This child died of a rare disease. Joe and Mary miss their child terribly. They have heard that there is a new IVF procedure that can ensure that they can have another child. However, their religion forbids using IVF. Use the resources assigned for this week and additional research,InstructionsSelect two of the situations above and then address 2 of the following:What is the relation between ethics and religion? Formulate and investigate the relation.For each case, determine the ethical path of conduct. Then, determine what paths of conduct would be unethicalFor each case, what would an emotivism say to appraise what you determine is the ethical form of conduct?For each case, would a natural law ethicist agree with what you say is the ethical form of conduct? Why or why not?Articulate, explain, and evaluate in each case an approach that makes use of divine command ethics.Writing Requirements (APA format)Length: 2-3 pages (not including title page or references page)1-inch marginsDouble spaced12-point Times New Roman fontTitle pageReferences page (minimum of 2 scholarly sources)
9 pages
Strategic Plan For Allina Health
The SWOT analysis conducted in the previous stage revealed several issues currently facing Allina Health Inc. The facility ...
Strategic Plan For Allina Health
The SWOT analysis conducted in the previous stage revealed several issues currently facing Allina Health Inc. The facility is struggling with nurse ...
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