The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.
Pharmaceutical Supply Chain Integrity and Security (2016)Arete-Zoe, LLC
The course material serves many interests by facilitating understanding of environment, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the first four chapters, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. In chapter “Enforcement”, we will introduce national enforcement systems in the context of globally operating pharmaceutical industry, and present major initiatives and events. Industry trends such as consolidation, outsourcing of key operations, and shift of manufacturing to Asia determine operational environment. Limited sourcing options, and increasing complexity and distance, affect vulnerability to disruption. Track and trace requirements introduced new vulnerabilities especially in the information management domain.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
This document discusses redesigning post-market drug safety surveillance. It proposes developing an integrated commercial off-the-shelf post-market surveillance platform to analyze real-world data on prescribing, patient outcomes, and adverse events in a standardized way. This could provide valuable insight into drug safety and efficacy using real-world evidence from clinical practice settings. Currently, post-market surveillance relies on voluntary reporting which results in underreporting and limited data for analyzing trends. The proposed platform aims to address these limitations through consistent analysis of real-world data sources.
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Availability of essential medicines in Hungary (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in Hungary. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern. Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines.
Pharmaceutical Supply Chain Integrity and Security (2016)Arete-Zoe, LLC
The course material serves many interests by facilitating understanding of environment, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the first four chapters, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. In chapter “Enforcement”, we will introduce national enforcement systems in the context of globally operating pharmaceutical industry, and present major initiatives and events. Industry trends such as consolidation, outsourcing of key operations, and shift of manufacturing to Asia determine operational environment. Limited sourcing options, and increasing complexity and distance, affect vulnerability to disruption. Track and trace requirements introduced new vulnerabilities especially in the information management domain.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
This document discusses redesigning post-market drug safety surveillance. It proposes developing an integrated commercial off-the-shelf post-market surveillance platform to analyze real-world data on prescribing, patient outcomes, and adverse events in a standardized way. This could provide valuable insight into drug safety and efficacy using real-world evidence from clinical practice settings. Currently, post-market surveillance relies on voluntary reporting which results in underreporting and limited data for analyzing trends. The proposed platform aims to address these limitations through consistent analysis of real-world data sources.
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
Avoidable Patient Harm and Resulting Liability Arete-Zoe, LLC
Avoidable Patient Harm and Resulting Liability
What would it take to improve our insight into the cost of avoidable patient harm?
Medications are the most frequent cause of adverse events in clinical settings.
Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage.
The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
Availability of essential medicines in Hungary (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in Hungary. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern. Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines.
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
This document discusses several topics relating to medical ethics, including patient confidentiality, autonomy, and beneficence. It notes that patient confidentiality is highly regulated by law in countries like the US, UK, and EU. Violations can result in civil, administrative, or criminal liability. The principle of patient autonomy means respecting a patient's right to make their own medical decisions, and violating that through actions like performing procedures without consent can constitute battery. However, doctors also have a duty of beneficence to act in the patient's best interests. The document examines some of the complex ethical dilemmas that can arise when balancing these duties.
Arete-Zoe is a consulting firm that provides services related to risk management in the pharmaceutical industry. They help clients address issues in clinical research, healthcare systems, and public health. Arete-Zoe analyzes vulnerabilities and provides recommendations to improve organizational effectiveness, business resiliency, and safety. Their services include assessing risks from manufacturing and supply chain issues, inspections, clinical trials, and other factors that can undermine the pharmaceutical industry.
Measuring the Relationship between Innovative Drugs and AE_2015Jonathan Bryan
This study used logistic regression to analyze the relationship between drug innovation classes and reported adverse events. It utilized a previous study's classification of 645 drugs from 1987-2011 into first-in-class, advanced-in-class, or addition-to-class based on FDA review designations. Adverse event data was obtained from FAERS reports from 2004-2014. The results found that total adverse events per drug followed a power law distribution, with most drugs having few events but some outliers with many. Logistic regression found a weak relationship between adverse events and innovation classes, except for more advanced-in-class drugs having higher lifetime adverse event totals. This highlights the need for more systematic drug outcome data to develop better models of drug
The document is a presentation about orphan drugs given by Dr. Atul Rajpara. It defines orphan drugs as those intended for the treatment of rare diseases or disorders. It discusses how rare diseases are defined in various countries and notes that over 7,000 rare diseases have been identified worldwide. The presentation outlines the Orphan Drug Act of 1983 in the US and its impact in incentivizing orphan drug development. It also discusses the orphan drug designation process and provides some examples of orphan drugs and their manufacturers. The presentation concludes by noting challenges to improving access to orphan drugs in India like affordability and a lack of incentives for drug developers.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
The Office of Orphan Products Development (OOPD) at the FDA promotes the development of treatments for rare diseases and conditions. There are more than 6,800 known rare diseases affecting an estimated 25-30 million Americans. The Orphan Drug Act of 1983 provides financial incentives like tax credits, user fee waivers, and exclusive marketing rights for 7 years to encourage development of treatments for rare diseases. The OOPD oversees programs that grant orphan drug designation, provide funding for clinical trials and natural history studies, and award priority review vouchers for rare pediatric diseases.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
This document discusses strategies for conducting clinical trials for rare diseases and orphan drugs. It begins with definitions of rare diseases and an overview of legislation related to orphan drugs. It then discusses considerations for site selection, recruitment, study execution, and monitoring that are unique to rare disease trials due to small patient populations and specialized needs. Key approaches include partnering with advocacy groups, using patient registries, minimizing patient burden, and providing tailored training and support to investigators and sites. The goal is to connect patients to trials and facilitate fast-track drug approval to meet significant unmet medical needs.
This document discusses the supply chain management of the pharmaceutical industry in Ghana and consumer perceptions of Ernest Chemists Limited as a pharmaceutical provider. It finds that Ernest Chemists Limited has an effective supply chain system that makes medicines available and affordable. However, the emergence of substandard drugs in Ghana is due to issues with distribution and quality standards. The study recommends that the Ghanaian government encourage local drug manufacturing by reducing taxes on ingredients to improve access and healthcare.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
‘Orphan drugs’ future growth potential for indian pharmaceutical marketNitin Patel
This document discusses orphan drugs and their potential in the Indian pharmaceutical market. It defines orphan drugs as those developed for rare diseases affecting less than 8% of the population. The US was the first to pass orphan drug legislation in 1983 to incentivize development of these drugs. Similar laws now exist in other countries and provide benefits like 7 years of market exclusivity. While initially developed for small populations, some orphan drugs like Rituxan have become very profitable blockbusters. The global orphan drug market was worth $50 billion in 2011 and is growing faster than other drug markets. Several Indian companies are now developing or manufacturing orphan drugs for rare diseases.
This document provides information about an upcoming conference on orphan drugs that will take place on October 18-20, 2016 in London. It includes details about the interactive workshops on the first day and key sessions over the two main conference days that will discuss topics such as regulatory challenges, developing treatments for rare diseases, pediatric orphan drug development, and partnerships in the orphan drug field. Information is provided on registering for the event and sponsorship opportunities.
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
Presentation at Advanced Intelligent Systems for Sustainable Development (AISSD 2021) 20-22 August 2021 organized by the scientific research group in Egypt with Collaboration with Faculty of Computers and AI, Cairo University and the Chinese University in Egypt
Literature screening for pharmacovigilance 190818Marnix Wieffer
This document discusses challenges in literature screening for pharmacovigilance and potential solutions. The key challenges are the high volume of scientific literature, poor signal-to-noise ratio, compliance risks for audits and inspections, duplicate articles, and increased workload from regulatory requirements. Technology solutions like automation, prioritization, text mining and machine learning can help address these challenges by improving workflow efficiency and compliance. Outsourcing literature screening services can also help reduce costs and resources needed while maintaining oversight and accountability.
The document discusses safety issues with the class of antibiotics known as fluoroquinolones (FQ) in Pakistan. It notes that FQ usage in Pakistan is 10 times higher than in other countries and reports of side effects are 100 times lower, indicating overuse and underreporting. The US FDA has issued multiple warnings about side effects of FQ including tendon rupture, peripheral neuropathy, low blood sugar, and aortic aneurysm. However, in Pakistan FQ are widely available without prescription and appropriately supervision, leading to unnecessary costs and burden on the healthcare system from preventable side effects. Public awareness efforts are needed to reduce this issue.
This report analyzes the US in vitro diagnostics industry, forecasting demand to reach nearly $25 billion by 2016. Clinical chemistry and immunoassay products are expected to remain the top sellers. Molecular diagnostic products will see the fastest growth due to advantages in detecting infectious diseases and cancer. Diabetes testing will also see gains due to increased blood glucose monitoring. The report profiles major industry players and provides historical data and forecasts by product type, application, and market through 2021.
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
This document discusses post-marketing surveillance of drugs. Post-marketing surveillance is important to identify undesirable drug effects that were not detected in pre-market clinical trials due to limited sample sizes. Several methods are used for post-marketing surveillance including spontaneous reporting, cohort studies, and case-control studies. The key goals of post-marketing surveillance are to obtain additional safety and efficacy information on drugs used in real-world settings and to detect rare or long-term adverse effects.
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
This document discusses several topics relating to medical ethics, including patient confidentiality, autonomy, and beneficence. It notes that patient confidentiality is highly regulated by law in countries like the US, UK, and EU. Violations can result in civil, administrative, or criminal liability. The principle of patient autonomy means respecting a patient's right to make their own medical decisions, and violating that through actions like performing procedures without consent can constitute battery. However, doctors also have a duty of beneficence to act in the patient's best interests. The document examines some of the complex ethical dilemmas that can arise when balancing these duties.
Arete-Zoe is a consulting firm that provides services related to risk management in the pharmaceutical industry. They help clients address issues in clinical research, healthcare systems, and public health. Arete-Zoe analyzes vulnerabilities and provides recommendations to improve organizational effectiveness, business resiliency, and safety. Their services include assessing risks from manufacturing and supply chain issues, inspections, clinical trials, and other factors that can undermine the pharmaceutical industry.
Measuring the Relationship between Innovative Drugs and AE_2015Jonathan Bryan
This study used logistic regression to analyze the relationship between drug innovation classes and reported adverse events. It utilized a previous study's classification of 645 drugs from 1987-2011 into first-in-class, advanced-in-class, or addition-to-class based on FDA review designations. Adverse event data was obtained from FAERS reports from 2004-2014. The results found that total adverse events per drug followed a power law distribution, with most drugs having few events but some outliers with many. Logistic regression found a weak relationship between adverse events and innovation classes, except for more advanced-in-class drugs having higher lifetime adverse event totals. This highlights the need for more systematic drug outcome data to develop better models of drug
The document is a presentation about orphan drugs given by Dr. Atul Rajpara. It defines orphan drugs as those intended for the treatment of rare diseases or disorders. It discusses how rare diseases are defined in various countries and notes that over 7,000 rare diseases have been identified worldwide. The presentation outlines the Orphan Drug Act of 1983 in the US and its impact in incentivizing orphan drug development. It also discusses the orphan drug designation process and provides some examples of orphan drugs and their manufacturers. The presentation concludes by noting challenges to improving access to orphan drugs in India like affordability and a lack of incentives for drug developers.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
The document summarizes the Orphan Drug Act of 1983 and its impact. It provides incentives like 7 years of marketing exclusivity and tax credits to stimulate development of drugs for rare diseases defined as affecting fewer than 200,000 people. Since 1983, over 1000 designations and 200 product approvals have occurred. While the Act has met its objectives, concerns around the high costs of orphan drugs and determining appropriate access and reimbursement are discussed.
The Office of Orphan Products Development (OOPD) at the FDA promotes the development of treatments for rare diseases and conditions. There are more than 6,800 known rare diseases affecting an estimated 25-30 million Americans. The Orphan Drug Act of 1983 provides financial incentives like tax credits, user fee waivers, and exclusive marketing rights for 7 years to encourage development of treatments for rare diseases. The OOPD oversees programs that grant orphan drug designation, provide funding for clinical trials and natural history studies, and award priority review vouchers for rare pediatric diseases.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
This document discusses strategies for conducting clinical trials for rare diseases and orphan drugs. It begins with definitions of rare diseases and an overview of legislation related to orphan drugs. It then discusses considerations for site selection, recruitment, study execution, and monitoring that are unique to rare disease trials due to small patient populations and specialized needs. Key approaches include partnering with advocacy groups, using patient registries, minimizing patient burden, and providing tailored training and support to investigators and sites. The goal is to connect patients to trials and facilitate fast-track drug approval to meet significant unmet medical needs.
This document discusses the supply chain management of the pharmaceutical industry in Ghana and consumer perceptions of Ernest Chemists Limited as a pharmaceutical provider. It finds that Ernest Chemists Limited has an effective supply chain system that makes medicines available and affordable. However, the emergence of substandard drugs in Ghana is due to issues with distribution and quality standards. The study recommends that the Ghanaian government encourage local drug manufacturing by reducing taxes on ingredients to improve access and healthcare.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
‘Orphan drugs’ future growth potential for indian pharmaceutical marketNitin Patel
This document discusses orphan drugs and their potential in the Indian pharmaceutical market. It defines orphan drugs as those developed for rare diseases affecting less than 8% of the population. The US was the first to pass orphan drug legislation in 1983 to incentivize development of these drugs. Similar laws now exist in other countries and provide benefits like 7 years of market exclusivity. While initially developed for small populations, some orphan drugs like Rituxan have become very profitable blockbusters. The global orphan drug market was worth $50 billion in 2011 and is growing faster than other drug markets. Several Indian companies are now developing or manufacturing orphan drugs for rare diseases.
This document provides information about an upcoming conference on orphan drugs that will take place on October 18-20, 2016 in London. It includes details about the interactive workshops on the first day and key sessions over the two main conference days that will discuss topics such as regulatory challenges, developing treatments for rare diseases, pediatric orphan drug development, and partnerships in the orphan drug field. Information is provided on registering for the event and sponsorship opportunities.
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
Presentation at Advanced Intelligent Systems for Sustainable Development (AISSD 2021) 20-22 August 2021 organized by the scientific research group in Egypt with Collaboration with Faculty of Computers and AI, Cairo University and the Chinese University in Egypt
Literature screening for pharmacovigilance 190818Marnix Wieffer
This document discusses challenges in literature screening for pharmacovigilance and potential solutions. The key challenges are the high volume of scientific literature, poor signal-to-noise ratio, compliance risks for audits and inspections, duplicate articles, and increased workload from regulatory requirements. Technology solutions like automation, prioritization, text mining and machine learning can help address these challenges by improving workflow efficiency and compliance. Outsourcing literature screening services can also help reduce costs and resources needed while maintaining oversight and accountability.
The document discusses safety issues with the class of antibiotics known as fluoroquinolones (FQ) in Pakistan. It notes that FQ usage in Pakistan is 10 times higher than in other countries and reports of side effects are 100 times lower, indicating overuse and underreporting. The US FDA has issued multiple warnings about side effects of FQ including tendon rupture, peripheral neuropathy, low blood sugar, and aortic aneurysm. However, in Pakistan FQ are widely available without prescription and appropriately supervision, leading to unnecessary costs and burden on the healthcare system from preventable side effects. Public awareness efforts are needed to reduce this issue.
This report analyzes the US in vitro diagnostics industry, forecasting demand to reach nearly $25 billion by 2016. Clinical chemistry and immunoassay products are expected to remain the top sellers. Molecular diagnostic products will see the fastest growth due to advantages in detecting infectious diseases and cancer. Diabetes testing will also see gains due to increased blood glucose monitoring. The report profiles major industry players and provides historical data and forecasts by product type, application, and market through 2021.
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
This document discusses post-marketing surveillance of drugs. Post-marketing surveillance is important to identify undesirable drug effects that were not detected in pre-market clinical trials due to limited sample sizes. Several methods are used for post-marketing surveillance including spontaneous reporting, cohort studies, and case-control studies. The key goals of post-marketing surveillance are to obtain additional safety and efficacy information on drugs used in real-world settings and to detect rare or long-term adverse effects.
How To Get Your Research Published in the BMJbmjslides
The document provides guidance for researchers on publishing their work, including choosing an appropriate journal, writing different sections of a research paper, and dealing with peer review and editorial processes. It discusses what editors look for in submissions and emphasizes the importance of transparency, ethics, and properly attributing contributions and conflicts of interest.
Creating a Comprehensive Drug Development PlanCovance
This white paper provides an overview of creating an integrated drug development plan, overcoming common development challenges and devising strategies that increase the likelihood of delivering a new, approved medicine to patients.
Guide to the advanced Market Access Quiz covering today's life science and health care challenges as e.g. precision medicine, value frameworks, managed entry agreements, HTA, digital health apps, cure by gene and cell therapies, budget impact, affordability, cross border collaboration, diagnostics, DRGs and many more
The late phase research environment has become more complex due to increased regulatory demands from the FDA and EMA for comprehensive safety data. Sponsors must begin planning late phase studies earlier in the investigative process and work with strategic research partners to effectively plan studies that address therapeutic, regulatory and economic concerns. Failing to take early action can result in costly delays and failure to obtain drug approval. Effective planning is essential to navigating today's complex late phase research landscape.
4 Environmental Analysis
Charles Dharapak/Associated Press
Organisations don’t exist in a vacuum. They are intricately connected to an
outside world with a constantly changing landscape.
—The Happy Manager
Learning Objectives
After reading this chapter, you should be able to do the following:
• Describe the environmental forces that create change and can influence an HCO’s strategic planning.
• Discuss the impact of legislation on HCO operations and strategic planning.
• Identify the main forces referred to in the five forces model of industry analysis.
• Explain why an HCO should continue to assess external opportunities and threats.
• List different benchmarks that can identify an HCO’s internal strengths and weaknesses.
• Explain the connections between an HCO’s strengths, weaknesses, and distinctive competencies.
• Name the advantages of the Integrated Practice Unit (IPU) as a healthcare delivery method.
Section 4.1External Analysis of Dominant Environmental Driving Forces
Introduction
This chapter discusses the importance and the components of an environmental analysis as
part of the strategic planning process for an HCO. This chapter introduces an external analysis
that uses a PESTLE framework for identifying the elements of the external environment. This
chapter then reviews legislation and governmental initiatives, which have a dramatic impact
on HCOs. Next, “Porter’s five forces” model, which also is known as the five forces model of
industry analysis, is explained and applied to an HCO. Finally, this chapter discusses internal
and external analyses and the use of a SWOT analysis, followed by an examination of how
resources, costs, and distinctive competencies affect strategic planning efforts.
4.1 External Analysis of Dominant
Environmental Driving Forces
It is vital for an HCO to gauge the external environment within which it operates. This, in fact,
should be standard practice for all organizations. Virtually anything that can happen prob-
ably will happen, eventually. We truly have no certainty about what things will be like in the
future, in spite of our attempts to make predictions or forecasts. Still, an HCO cannot afford to
let generalized eventualities and uncertainties keep it from being active in strategic planning,
and changing in response to environmental demands.
PESTLE is an acronym to describe the elements of the external environment that impact
an HCO’s planning process. These elements require specific analysis about their current or
potential impact on the organization’s planning and operations. PESTLE stands for politi-
cal, economic, sociocultural, technological, legal and eco-environmental forces, which exert
strong influences on how an HCO crafts and executes strategic plans. Figure 4.1 shows the
elements of PESTLE.
These elements also interact with each other to create additional ramifications. Consider
medical waste. Medical waste first came to the attention of.
Application of Machine Learning in Drug Discovery and Development LifecycleAI Publications
Machine learning and Artificial Intelligence have significantly advanced in recent years owing to their potential to considerably increase the quality of life while reducing human workload. The paper demonstrates how AI and ML are used in the drug development process to shorten and enhance the overall timeline. It contains pertinent information on a variety of Machine Learning approaches and algorithms that are used across the whole drug development process to speed up research, save expenses, and reduce risks related to clinical trials. A range of QSAR analysis, hit finding, and de novo drug design applications are used in the pharmaceutical industry to enhance decision-making. As technologies like high-throughput screening and computation analysis of databases used for lead and target identification and development create and integrate vast volumes of data, machine learning and deep learning have grown in importance. It has also been emphasized how these cognitive models and tools may be used in lead creation, optimization, and thorough virtual screening. In this paper, problem statements and the corresponding state-of-the-art models have been considered for target validation, prognostic biomarkers, and digital pathology. Machine Learning models play a vital role in the various operations related to clinical trials embracing protocol optimization, participant management, data analysis and storage, clinical trial data verification, and surveillance. Post-development drug monitoring and unique industrially prevalent ML applications of pharmacovigilance have also been discussed. As a result, the goal of this study is to investigate the machine learning and deep learning algorithms utilised across the drug development lifecycle as well as the supporting techniques that have the potential to be useful.
Application of Machine Learning in Drug Discovery and Development LifecycleAI Publications
Machine learning and Artificial Intelligence have significantly advanced in recent years owing to their potential to considerably increase the quality of life while reducing human workload. The paper demonstrates how AI and ML are used in the drug development process to shorten and enhance the overall timeline. It contains pertinent information on a variety of Machine Learning approaches and algorithms that are used across the whole drug development process to speed up research, save expenses, and reduce risks related to clinical trials. A range of QSAR analysis, hit finding, and de novo drug design applications are used in the pharmaceutical industry to enhance decision-making. As technologies like high-throughput screening and computation analysis of databases used for lead and target identification and development create and integrate vast volumes of data, machine learning and deep learning have grown in importance. It has also been emphasized how these cognitive models and tools may be used in lead creation, optimization, and thorough virtual screening. In this paper, problem statements and the corresponding state-of-the-art models have been considered for target validation, prognostic biomarkers, and digital pathology. Machine Learning models play a vital role in the various operations related to clinical trials embracing protocol optimization, participant management, data analysis and storage, clinical trial data verification, and surveillance. Post-development drug monitoring and unique industrially prevalent ML applications of pharmacovigilance have also been discussed. As a result, the goal of this study is to investigate the machine learning and deep learning algorithms utilised across the drug development lifecycle as well as the supporting techniques that have the potential to be useful.
The document discusses pharmacovigilance (PV), which involves monitoring safety of drugs after approval. It notes that drug-related deaths are a leading cause of mortality in the US and India. PV aims to detect, assess, and prevent adverse drug reactions. Career opportunities in PV are growing due to requirements for post-marketing safety monitoring and large databases. Training programs provide qualifications for PV roles in pharmaceutical companies, contract research organizations, and government agencies focused on ensuring drug safety.
The document discusses improving medication adherence and the complex landscape of issues involved. It notes that non-adherence results in high healthcare costs and negative health outcomes. Pharma companies are engaging with adherence issues due to business risks from lower sales and regulatory scrutiny. The landscape is complex with many patient, stakeholder, and systemic factors influencing adherence. Human-centered design and the transtheoretical model of behavior change are recommended approaches for developing well-targeted adherence solutions. Connected health technologies also show promise if designed with privacy, costs, and usability in mind.
6 Game-Changing Tips to Deal with Risk Management and Drug Safety AuditDarwin Jayson Mariano
There are unique challenges to pharmacovigilance in Asia, including a lack of trained personnel, unrealistic expectations from regulators, safety issues around traditional medicines, and poor reporting. To effectively address these challenges, companies must establish comprehensive drug safety and risk management strategies that consider all aspects of risk identification, analysis, and response. Key elements include monitoring programs to quickly identify drug risks, periodic safety reports, careful signal analysis accounting for demographic factors, and education initiatives for healthcare providers and patients.
Navigate 2 Scenario for Health PolicyEpisode 1Policy An.docxmayank272369
Navigate 2 Scenario for Health Policy
Episode 1:
Policy Analysis and Development
Overview
In this episode, you will be in a health care policy internship program in a Senator’s office in Washington, D.C. The Senator wants to develop policy that requires all health care organizations that receive federal funds to implement the recommendations presented in the Institute of Medicine reports on quality care. You will develop a policy, so that it can become proposed legislation. You must collect data, describe the problem, solutions and related ethical issues, examine the cost-benefit analysis, identify stakeholders (such as lobbyists from American Hospital Association, health care providers, health care corporations, pharmaceuticals, insurers, etc.), and impact. Based on this information, you will create a policy description that will be the foundation for a bill. You will describe critical issues that would be in the bill such as requirements of hospitals to:
Monitor and report medical errors to the Department of Health and Human Services
Use root cause analysis on a certain percentage of errors
Track and report patient outcomes focused on the clinical problems identified in the
National Health Care
Quality Report
Integrate the 5 health care profession core competencies into staff education and track outcomes
Establish a no-blame culture
*I suggest for you to do some research on your own, and if you use outside sources to help your compile your policy description, be sure to reference them (following an APA format) at the end of your post.
Assignment
You will post a policy description to this discussion board forum. Make sure to identify a plan that addresses legal and ethical issues in a health care policy. You must also respond to 2 of your peers' posts and make sure to reference any outside sources you may have used in your recommendation.
Below are the characters from this LearnScapes scenario (LearnScapes for
Health Policy
1):
The Student (which is you), Health Care Policy Intern for Congress
The student used to work within the Bright Road Health Care System, and had a special interest in policy. The student is thinking about moving into politics, hoping to make a difference at that level. The student has just been accepted into the internship; this is the student’s first big project.
Peter Shackley, Senior Policy Staff Member
The student’s mentor, Peter, is a young and feisty staff member. In his late 20s, Pete has been interested in politics since he was President of his high school student body. He’s especially passionate about policy-making and how the process works. Pete will help guide the student through the policy-making process.
Gretchen Wilde, Senator Chief of Staff
Gretchen is in her 30s and has been the Senator’s Chief of Staff for about 2 years now. She’s very professional, and holds high expectations for everyone in the Senator’s office, including interns. Gretchen is responsible for reviewing polic.
The document discusses the importance of early clinical recruitment planning for drug development programs. It notes that delays in recruitment can significantly increase costs and impact revenue opportunities due to later market entry. Early planning allows consideration of factors like disease characteristics, enrollment population size, competition, and protocol challenges that influence feasibility. Comprehensive recruitment programs costing 1-12% of delay costs can help avoid delays and ensure timely trial completion and drug approval.
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
This study assessed the transparency of websites of Italian patient/consumer groups and pharmaceutical companies regarding funding disclosure. It found:
1) Only 29% of patient/consumer group websites and 76% of pharmaceutical websites disclosed any industry funding. Disclosure was often incomplete.
2) Of groups disclosing funding, few reported funding amounts (6%) or activities funded (54%). None reported what proportion was from industry.
3) Disclosure was more common on national/regional vs local group websites. More diabetes and cancer group websites had industry links/ads than disclosed funding.
4) Of companies disclosing funding, few detailed activities funded (31%) or amounts (15%). Disclosure varied between company home countries
CONNECTED HEALTH Thesis - Loïc RICCI ReportLoïc RICCI
This document is an abstract for a thesis paper on the potential benefits of connected health for users and society. The paper explores the growing field of connected health and its applications. The author argues that connected health, which collects health information through sensors and monitors patients remotely, has the potential to maximize human life expectancy and quality by providing constant health monitoring and early detection of health issues. However, widespread adoption of connected health also faces challenges regarding data security, technological barriers for users, impacts on the healthcare industry workforce, and determining appropriate regulations and oversight. The thesis will examine both the benefits of connected health as well as the issues that need to be addressed for its effective implementation.
NURS 6050 GCU Nursing in Florida Presentation.docxstirlingvwriters
This document discusses a presentation for NURS 6050 on nursing regulation in Florida. It provides an overview of boards of nursing and professional nursing associations. The presentation assignment requires describing differences between these groups, the board that regulates nursing in Florida, and how federal and state regulations influence nursing practice and healthcare delivery, costs, and access. Key sources on nursing organizations are also provided.
D1.2 Review of Policies of Perspectives on Real-World DataAmr Makady
This document provides a review of different stakeholders' policies and perspectives on using real-world data (RWD) for early drug development and clinical effectiveness assessment. Interviews were conducted with 19 stakeholders from 7 groups. In general, policies on RWD collection and use differ between stakeholders due to their different goals. Cultural barriers, a lack of standardization, and ambiguity in policies pose challenges to incorporating RWD. Increased collaboration is needed to develop common understandings and address issues regarding governance, evidence requirements, and research methods.
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdfArete-Zoe, LLC
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)Arete-Zoe, LLC
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populationsArete-Zoe, LLC
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...Arete-Zoe, LLC
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward Arete-Zoe, LLC
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745 Arete-Zoe, LLC
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
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Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)Arete-Zoe, LLC
JB, a 23-year-old female, presented to the emergency department with fever, chills, nausea and abdominal pain. She was diagnosed with sepsis and treated initially with antibiotics and IV fluids. Her condition deteriorated after being transferred to a non-emergency ward, as key safety parameters like hypotension and elevated lactate were missed during handover. By Sunday, her symptoms met the criteria for septic shock, including low blood pressure, increased heart rate, and elevated lactate levels, indicating critical organ dysfunction from sepsis.
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Comparing Stability and Sustainability in Agile SystemsRob Healy
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
Employment PracticesRegulation and Multinational CorporationsRoopaTemkar
Employment PracticesRegulation and Multinational Corporations
Strategic decision making within MNCs constrained or determined by the implementation of laws and codes of practice and by pressure from political actors. Managers in MNCs have to make choices that are shaped by gvmt. intervention and the local economy.
Enriching engagement with ethical review processesstrikingabalance
New ethics review processes at the University of Bath. Presented at the 8th World Conference on Research Integrity by Filipa Vance, Head of Research Governance and Compliance at the University of Bath. June 2024, Athens
Make it or Break it - Insights for achieving Product-market fit .pdfResonate Digital
This presentation was used in talks in various startup and SMB events, focusing on achieving product-market fit by prioritizing customer needs over your solution. It stresses the importance of engaging with your target audience directly. It also provides techniques for interviewing customers, leveraging Jobs To Be Done for insights, and refining product positioning and features to drive customer adoption.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
12 steps to transform your organization into the agile org you deservePierre E. NEIS
During an organizational transformation, the shift is from the previous state to an improved one. In the realm of agility, I emphasize the significance of identifying polarities. This approach helps establish a clear understanding of your objectives. I have outlined 12 incremental actions to delineate your organizational strategy.
Sethurathnam Ravi: A Legacy in Finance and LeadershipAnjana Josie
Sethurathnam Ravi, also known as S Ravi, is a distinguished Chartered Accountant and former Chairman of the Bombay Stock Exchange (BSE). As the Founder and Managing Partner of Ravi Rajan & Co. LLP, he has made significant contributions to the fields of finance, banking, and corporate governance. His extensive career includes directorships in over 45 major organizations, including LIC, BHEL, and ONGC. With a passion for financial consulting and social issues, S Ravi continues to influence the industry and inspire future leaders.
Integrity in leadership builds trust by ensuring consistency between words an...Ram V Chary
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
Public Speaking Tips to Help You Be A Strong Leader.pdfPinta Partners
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
1. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 1 of 19
1334 E Chandler Blvd # 5 A-19
Phoenix 85048, AZ, USA
T: +1-480-409-0778
COURSE SYLLABUS
ARETE-ZOE, LLC
Course Title: Global Pharma Primer CPE credits: n/a
Course Number: Length: 10 weeks
Instructor: Arete-Zoe Estimated study time; 6-10 hours a week
Delivery method: Indirect (Internet)
Catalog Description:
The material included in these modules serves many interests by facilitating understanding of construct,
dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately
determine access, availability, and effectiveness of pharmaceutical products. In the following modules
we will introduce and describe the highly specialized and often disconnected components of
pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and
practices, and use case studies to qualify the relative effectiveness of safeguards to prevent
harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected
both aspects of public concern within a global context because transnational interests influence national
circumstances.
Instructor comments:
All essential support materials for this course are provided as assigned readings. Students are
encouraged to submit a brief profile, detailing their background and professional experience and
interests. The information will remain confidential but will be used to refine course scenarios and
themes in order to establish relevant entry points for participants. It is recommended that students
establish, at their expense, an account with on-line library service. Although not essential for the
completion of this course, students are encouraged to explore and review provided further readings to
appreciate complexity and extent of the topic in question. Full texts of academic papers, rather than
mere abstracts which are available from free libraries such as PubMed, provide better understanding
what kind of information can be and cannot be obtained from published biomedical literature.
2. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 2 of 19
Broad competencies and terminal objectives:
Explain how risk to patients and trial subjects is identified, measured, and communicated in
pharmaceutical industry, and define limitations of such approach
Define operational environment in pharmaceutical industry: datascape, process timeline, and
participants, and describe availability of these datasets to other stakeholders
Explain the most important differences in enforceability of international standards, and the role of
national regulators and extraterritorial FDA in globalized pharmaceutical industry
Discuss the legal justification for major criminal and civil settlements in explain how compensation
for Adverse Drug Events (ADEs) relate to civil litigation
Discuss landmark cases in pharmaceutical industry and their impact
Describe main trends in pharmaceutical industry and their impact on resiliency against disruptions
Define how pharmaceutical industry fits into national critical infrastructure in the U.S., EU, India and
China, and what these nations do to gain/maintain self-sufficiency/competitive advantage
Interpret main issues in intellectual property infringements
Discuss human factors as a contributing cause in the cumulative sector dysfunction
Course Material List:
Required: None, all necessary materials are linked to each module. References and
informational extracts and factsheets derive from non-commercial publications,
information available from regulatory agencies, news coverage, and publicly
accessible databases. Assigned readings are required for completion of the
course.
Recommended: Further readings expand on the topic and provide context and depth of
understanding of the topic. These materials are not essential for completion of
the course.
Required software: No specialized software required.
This course consists of five modules. Each module correlates to a two-week period and includes assigned
readings and a corresponding comprehension quiz. Additionally, within each module, students will
conduct a practical exercise based upon case study or write an opinion piece in the group discussion on a
topic posted by the instructors. Authors will defend/argue their position in instructor-facilitated group
discussion. Chat sessions will be scheduled for live collaborative exchanges. Selected contributions from
participating students will be presented in Bonus lecture in the end of the course.
Evaluation:
Students will respond to scheduled quizzes designed to help students assess their understanding of
items of particular importance. The final grade will be determined by the quizzes, practical exercises and
opinion pieces/case studies, final exam, and collaborative participation.
3. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 3 of 19
Final Grade:
Comprehension quizzes 25% of the final grade
Practical exercises, opinion pieces, case studies 25% of the final grade
Collaborative participation in discussions 25% of the final grade
Final exam 25% of the final grade
Course breakdown
Contents
Broad competencies and terminal objectives:.......................................................................................... 2
Course breakdown................................................................................................................................... 3
MODULE I – HUMAN CRISIS ................................................................................................................. 4
MODULE II – OPERATIONAL ENVIRONMENT......................................................................................... 6
MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES........................................... 8
MODULE IV – LEGAL BATTLES............................................................................................................. 11
MODULE V – GLOBALIZATION ............................................................................................................ 13
BONUS LECTURE ................................................................................................................................ 14
Course Road Map……………………………………………………………………………………………………………………………………15
4. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 4 of 19
MODULE I – HUMAN CRISIS
Overview: Human crisis, patient casualties
Significant and persistent harm is inflicted, because of process failures and vulnerabilities. Harm includes
injury and death to trial subjects and to patients after drug approval. Harm is also inflicted by failure to
treat conditions for which safe and effective treatment is available, inappropriate medication, and failure
to develop and approve safe and effective medications for major public health problems. Significant and
persistent harm is inflicted on patients because patient casualties are the only driver of change toward a
safer system. Unlike in engineering in which risk can be identified without actual death/injury through
the assessment of systemic controls, in pharmaceutical industry actual death or injury is the only way to
prove there is a risk to patients. Pharmacovigilance system is based on active reporting of ADRs by
healthcare professionals and patients to drug license holders and/or regulators. Although drug license
holders have the obligation to disclose reports they received to regulators in a timely manner, this does
not always occur. Because of inability to independently verify true performance of the drug on the
market, hazard identification and risk communication largely depend on industry’s voluntary disclosure.
Adverse Drug Events (ADEs) are an important public health issue, namely because of additional costs of
disability/incapacity to the system and to the individuals. Module I explains causes of harm to trial
subjects and to patients after drug approval and basic concepts used in the industry to identify hazards
and communicate risks. Public health implications of unidentified/unmitigated hazards are analyzed,
including estimated human toll and monetary costs of adverse effects of medicines and medication
errors as well as under-treatment. Challenges in individual assessment of risk are also discussed.
Module Objectives:
By the end of this module, the student will be able to:
Explain basic concepts of identification of drug-related hazards and risk communication in
pharmaceutical industry
Discuss public health implications and system/individual costs of adverse drug events and reactions
Differentiate predictable and preventable ADEs from those unforeseen and non-preventable
Estimate probability of occurrence of adverse effects based on information they can find in product
labels.
Module Activities:
Directed readings orient on hazard identification concepts in pharmaceutical industry, both in clinical
research and in post-approval use explained on historical examples which triggered systemic change.
Students will extrapolate from assigned readings and presentations to locate relevant information in
publicly available sources and evaluate its content.
Reading Assignment:
View presentation: Human crisis
View presentation: Assignment Guide
o FDA: A History - Pre 1906 (2008)
o Fast The Latest News: The Tragic Death of President James Garfield
5. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 5 of 19
o Shuster, Evelyne. Fifty Years Later: The Significance of the Nuremberg Code
o World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research
Involving Human Subjects
o Winerip, Michael. The Shadow of the Thalidomide Tragedy
o IMNG: FDA Panels Revisit Rosiglitazone’s Cardiovascular Safety
o FDA. Sulfanilamide Disaster: Taste of Raspberries, Taste of Death The 1937 Elixir
Sulfanilamide Incident
o Allison Dnamap. Pharmacogenetics (PGx)/Pharmacogenomics Thorough Introduction.
Practical exercise:
Drug label is the main document which communicates risk-benefit profile of a drug to healthcare
professionals and patients. Familiarity with the document and its format and language is essential. It also
shows that the same drug comes with different information in different jurisdictions (U.S. v. EU). Lipitor
is a well-known drug; it will be discussed again in part on litigation; and the information provided in both
versions (U.S. and U.K.) is consistent. The drug is prescription only, but there was a long debate that the
drug would be available to patients OTC (over-the-counter). Patients are expected to be able to extract
basic information from the label.
Read document online: 1 Patient Information Leaflet - UK
Read document online: 2 Summary of Product Characteristics – UK
Read document online: 3 Physician Prescribing Information – USA
Read document online: 4 Patient Product Information – USA
Further Readings:
See bibliography
Evaluation:
Comprehension Quiz
Practical exercise: Locate requested information in the provided drug labels.
6. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 6 of 19
MODULE II – OPERATIONAL ENVIRONMENT
Overview: Operational environment: Research concepts, process timeline, datascape, and participants
Solution shall be developed in sequence. The first and essential part of solution development is
accurately defined operational environment. Operational environment in pharmaceutical industry is
defined by generally accepted scientific research concepts; timeline the industry follows to produce the
data necessary to achieve its objectives; and participants and their respective commercial interests. This
module defines operational environment in pharmaceutical industry. Specifically it elucidates basic
concepts used in pharmaceutical research, explains basic types of design of clinical trials, describes the
process timeline, indicates key steps in the process of drug development and commercialization, places
these steps on a timeline, identifies datasets produced in each stage of development, lists and classifies
individual participants and stakeholders in the pharmaceutical industry, and recognizes their business
purpose in order to acknowledge their self-interest biases and predict their behavior within the system.
The module presents basic principles of Good Clinical Practice (GCP), Good Manufacturing Practice
(GMP), and Good Pharmacovigilance Practice (GPvP) and their implementation and enforceability
around the world.
Module Objectives:
By the end of this lecture, the student will be able to:
Define main components of operational environment in the pharmaceutical industry
Describe basic research concepts in pharmaceutical research and types of design of clinical trials
Explain how the industry measures performance of the drug research and development system
Indicate key steps in the process of drug development and place them on a timeline
Identify datasets produced in each stage of drug development and commercialization
List individual participants in pharmaceutical industry, and recognize their business purpose
Define availability of datasets produced by individual participants to other stakeholders
Define self-interest biases of individual participants.
Utilize publicly available registries to locate and download information on clinical trials for analysis
Match published studies to registered clinical trials to detect publication bias and multiple
publication bias
Module Activities:
Directed readings orient on operational environment in the pharmaceutical industry, basic research
concepts in pharmaceutical research including design of clinical trials, and essential guidelines in clinical
research. Students will extrapolate from assigned readings and presentations to select a trial design in
which the trial subjects are most/least likely to receive investigational product, standard treatment, or
placebo. Students will be asked to match published studies to registered clinical trials to detect
publication bias and multiple publication bias.
Reading Assignment:
View presentation: Operational environment
Familiarize yourself with key resources: Assignment Guide
7. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 7 of 19
o View video: Hamilton, G: Body parts on a chip, TED Talks
Further reading:
See bibliography
Evaluation:
Comprehension quiz
Practical exercise I: This exercise is designed to allow students to apply their knowledge of
terminology and designs of clinical trials. This is essential to practically master content of this module
and retain knowledge for future use. Informed consent is only relevant if the user understands basic
research concepts and applies the knowledge in a real situation. Research fraud will be discussed in
Module III (Systemic vulnerabilities).
Practical exercise II: This exercise is designed to guide students through the process of search,
collation, and assessment of information available on drugs under development and approved drugs
in public domain. Students will be able to utilize publicly accessible resources to obtain relevant data
from two major clinical trial registries – ClinicalTrials.gov and ICTRP, and from medical literature
database PubMed, and to compare the datasets. Approved US and EU label will be provided as a
reference material. A series of guiding questions will lead students through analysis of the datasets,
specifically to compare approved indications vs. indications under investigation, geographical origin
of data, publication bias and multiple publication bias, availability of study results, and timing of
publication of results in medical journals with respect to drug approval.
8. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 8 of 19
MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES
Overview: Systemic vulnerabilities and risk reduction measures
Module III summarizes participants’ objectives, describes system goals in its ideally balanced state, and
design requirements of a safe system and its safety constraints. Systemic hazards are identified in the
drug development process, approval and commercialization. Examples of failure to detect safety issues
using current methods of detection of drug toxicity in clinical research and post-approval use are
presented to demonstrate vulnerability of the system. The process of regulatory review and approval is
presented on a decision-tree model to show instances of correct and incorrect rejection and approval.
Differing interests and motivators of individual stakeholders and inherent systemic risks are explained on
a series of drug withdrawals adjudicated to the part of process where the system had failed. Specific
examples of drug withdrawn or severely restricted for safety reasons are broken down to demonstrate
where, how, and why the system failed to identify/address the safety concern before inflicting serious
harm to trial subjects and patients.
Module Objectives:
By end of this module, the student will be able to:
Summarize objectives of participants in drug development
Describe system goals and design requirements, and safety constraints
Define systemic hazards in the drug development process, approval and commercialization
Explain principles and methods of hazard identification and mitigation in pharmaceutical industry
Correlate cause of failure to process timeline on a series of specific examples
Module Activities:
Directed readings orient on identification of systemic hazards in the pharmaceutical industry and specific
examples of safety withdrawals as they occurred. Case studies will be adjudicated to process timeline
with explanation why and how the specific failure occurred. Students will explore publicly available
information on drug safety withdrawals and discuss why the system failed to identify/address the safety
concern before inflicting serious harm to trial subjects and patients. The students will analyze
consistency of safety measures employed around the world on a series of specific examples.
Assigned reading:
Materials included in assigned reading explain fundamental principles of assessment of toxicity of
pharmaceuticals and limitations in prediction of their adverse effects. The materials guide students
through the process in historical context which is necessary to understand why some disasters could not
be discovered in the past. Limitations of knowledge and technology at time of safety review have to be
distinguished from evidence of toxicity which was at the time of review ignored. Summary article on
differences in withdrawal between the U.S. and other countries shows inconsistent approach of
regulators globally toward the assessment of limiting toxicity. A series of examples of drugs withdrawn
for safety reasons shows where the process failed in each particular case to detect the safety problem
before the drug reached the market.
9. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 9 of 19
View presentation: Systemic vulnerabilities, risk reduction measures and specific examples
View presentation: Assignment guide
Case studies:
Materials included in assigned reading explain fundamental principles of assessment of toxicology of
pharmaceuticals and limitations in prediction of their adverse effects. The materials guide students
through the process in historical context which is necessary to understand why some disasters could not
be discovered in the past. Limitations of knowledge and technology at time of safety review have to be
distinguished from evidence of toxicity which was at the time of review ignored. Summary article on
differences in withdrawal between the U.S. and other countries shows inconsistent approach of
regulators globally toward the assessment of limiting toxicity. A series of examples of drugs withdrawn
for safety reasons shows where the process failed in each particular case to detect the safety problem
before the drug reached the market.
TGN1412
Troglitazone
Thalidomide
Diethylstilbestrol
Triparanol
Mefloquine
Rosiglitazone
Trovafloxacin
Fen-Phen (exercise)
Assigned reading:
Speid: Lessons Learned From the TeGenero First-in-Man Phase 1 Clinical Trial
Taniguchi: Drug toxicity
FDA Clinical White Paper 2000: Hepatotoxicity
Huang: Predicting adverse side effects of drugs
Ninan: Withdrawing drugs in the U.S. v other countries
Jacobs – Hatfield: History of chronic toxicity and animal carcinogenicity studies for
pharmaceuticals
Videos:
Herbst, Arthur. 40th Anniversary of DES Paper.
Nevin, Remington. Neuropsychiatric Adverse Events Associated with Mefloquine.
O’Reilly, Rita. “RTE’s Investigations Unit Asks If the Anti-Malarial Drug Lariam Be Linked to
Suicides among Irish Defence Forces Soldiers.”
Democracy Now: WikiLeaks Cables: Pfizer Targeted Nigerian Attorney General to Undermine Suit
Further reading:
See bibliography
10. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 10 of 19
Evaluation:
Comprehension quiz
Practical exercise: Utilizing provided resources, students will define cause of failure to detect a
safety concern on the example of Fen-Phen.
11. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 11 of 19
MODULE IV – LEGAL BATTLES
Overview: Legal battles in pharmaceutical industry and why they matter
Module IV compares securities class action settlements in pharma to other industries, as well as trends
in federal and state settlements which resolved criminal and civil liabilities resulting from violations of
Food, Drug and Cosmetics Act and the False Claims Act; qui tam provision of the False Claims Act, and
the Foreign Corrupt Practices Act. Since the largest fines related to off-label promotion of approved
drugs, special attention is paid to specifics of marketing and advertising of pharmaceuticals. Landmark
cases which had major impact on pharmaceutical industry are briefly explained: Robertson v. Mc Gee
and its significance for the accountability of IRB/ECs; securities fraud cases Dura Pharmaceutical Inc. v
Broudo and Halliburton v Erica P John Fund; free speech cases Sorrell v IMS Health Inc. and U.S. v
Caronia; Wyeth v Levine as an example of successful state tort product liability claim; limitations on
liability of generic manufacturers as expressed in Pliva v Mensing and Mutual v Bartlett; and U.S. ex-rel.
Ge v Takeda as an example of unsuccessful qui-tam suit with impact on interpretation of reporting
obligations. Overall trends in personal injury lawsuits are presented and notable settlements are
discussed. This module compares and contrasts the correlations between criminal and civil settlements
and product liability lawsuits in the context of actual patient casualties, and discusses ambiguous liability
that results in rare compensation to the victims for safety failures.
Module Objectives:
By the end of this module, the students will be able to:
Compare securities class action settlements in pharma to other industries
Explain the basis for criminal and civil liability in the largest pharma settlements
Discuss the implications of off-label promotion of approved drugs
Comment on overall trends in personal injury lawsuits and discuss notable cases
Discuss landmark cases which had large impact on pharma
Discuss if and how settlements and lawsuits motivate stakeholders in pharmaceutical
industry to make pharmaceuticals safer for patients and trial subjects
Relate settlements to patient casualties
Module Activities:
Directed readings orient on grounds for prosecution and largest settlements relating to off-label
promotion of approved drugs, as the most important regulatory enforcement activity, and the impact of
landmark cases in pharmaceutical industry. Students will extrapolate from assigned readings and
presentations to comment on a series of questions posted by instructors.
Reading Assignment:
View presentation: Legal battles in pharmaceutical industry
View presentation: Resource Guide
Landmark Cases
o Robertson v McGee
o Dura Pharmaceuticals v Brouda
o Sorrell v IMS Health
12. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 12 of 19
o Halliburton v EPJ Fund
o Wyeth v Levine
o Pliva v Mensing
o Mutual v Bartlett
o U.S. v Caronia
o U.S. v ex-relator Ge v Takeda
o (GVK Biosciences scandal)
Marketing & Advertising
o FDA untitled & warning letters 2014
Federal Settlements
o Largest FDCA and FCA settlements
FCPA:
o GSK Chinese bribery scandal, 2013
Meningitis Outbreak, 2012
Personal Injury lawsuits – Notable Settlements
o Breast implants class action 1994
o Risperidal
o Vaginal meshes
o M-o-m hip implants
o Blood thinners
o Asbestos
o Lipitor, Crestor, Zocor
o Nigerian Trovan trials (ATS clause)
o EU PIP crisis
Evaluation:
Comprehension quiz
Participation in discussion: Students have to post at least 2 qualifying contributions (min. 200
words per contribution) in discussion topics posted by instructors.
13. Global Pharma Primer: Syllabus and Road Map Arete-Zoe, LLC
Date: July 2015 Page 13 of 19
MODULE V – GLOBALIZATION
Overview: Globalization in pharmaceutical industry
Module V explains the impact of globalization on resiliency of the system, starting with geolocation of
key activities around the world (big pharma and biotech headquarters, manufacturing, clinical research),
important shipping routes, namely vulnerability to disruptions and creation of strategic dependency in
commodity which is part of critical infrastructure. The module breaks down the process of drug
development, approval, and commercialization by location where these activities mostly take place, and
illustrates important trends within the industry such as consolidation, outsourcing and globalization.
Special attention is paid to globalization of enforcement activities of the FDA, its partnerships with
national regulators in India, China and Europe, and global initiatives that address counterfeiting and
intellectual property rights infringements. Human factors in cumulative sector dysfunction are discussed
as the consequence of globalization and consolidation of the industry, specifically limited cross-training
and overspecialization, creation of data, personnel and communication silos, vested interests, and
exploitation of human frailties especially during the time of global economic recession.
Module Objectives:
By the end of this lecture, the student will be able to:
Indicate geographical location where key activities in pharmaceutical industry mostly take place and
show main shipping routes
Evaluate impact of consolidation, globalization and outsourcing in pharmaceutical industry
Describe the role of national regulators and extraterritorial FDA with regards to oversight of
manufacturing of pharmaceuticals produced in India and China
Define how pharmaceutical industry fits into national critical infrastructure in the U.S., EU, India and
China, and what these nations do to gain/maintain self-sufficiency/competitive advantage
Describe main trends in pharmaceutical manufacturing and their impact on resiliency of the sector
against disruptions
Describe impact of counterfeiting on resiliency of supply chain and distribution chain
Interpret main issues in intellectual property infringements
Discuss human factors as a contributing cause in the cumulative sector dysfunction
Module Activities:
Directed readings will orient on impact of consolidation, globalization and outsourcing in pharmaceutical
industry and the role of counterfeiting and intellectual property infringements, strategic dependencies,
and vulnerability of supply chain to disruption as a consequence of these trends. Students will
extrapolate from assigned readings to discuss the roles of national regulators in this increasingly
globalized sector, and how these interdependencies and influences affect behavior of individual
stakeholders and participants to consider patient and research subject safety and well-being.
Reading Assignment:
Read provided material: Critical infrastructure in the U.S. and the EU
View presentation: Global Pharma Geography
o Review resources: Main shipping routes and maritime security incidents
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Date: July 2015 Page 14 of 19
o Read document: 2014 Special 301 Report (Counterfeiting)
o Read case study: Exubera (Human factors)
o Read document: Beijing Review. China Pledges to Speed Entry of U.S. Pharmaceuticals.
o View video: Food and Drug Administration. FDA’s Global Transformation.
o View video: PhRMA. Foreign Sourced Active Pharmaceutical Ingredients vs. Imported
Drugs.
o Read article: Poustourli, A, and Naouma, K. “Standards for Critical Infrastructure
Protection (CIP) - The Contribution of ERNCIP.”
o Read document: WTO. “Implementation of the WTO General Council Decision on
Paragraph 6 of the DOHA Declaration on the Trips Agreement and Public Health - Health
Economics and Drugs Series No. 016,” 2004.
Further reading:
See bibliography.
Evaluation:
Comprehension quiz
Participation in discussion: Students have to post at least 2 qualifying contributions (min. 200 words per
contribution) in discussion topics posted by instructors.
BONUS LECTURE
Best contributions from student discussions will be presented in the form of bonus lecture, which will be
made available in the form of free preview.
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MODULE I – HUMAN CRISIS
Causes of harm to patients and trial subjects
Injury and death to trial subjects
Injury and death to patients after approval
Safety v Security
Hazard identification in engineering and computer science
Hazard identification in pharmaceutical industry
Pharmacovigilance system
Public health implications of unidentified/unmitigated risks
Individual assessment of risk
FURTHER READING ASSIGNED READING
New life science doctrine: Miasmic vs.
Germs theory
New life science doctrine: The death of
President Garfield
Early FDA history: patent medicines,
the Wiley Act, 1938 FDCA, tetanus
serum, sulfanilamide disaster
FDA history pre-1906
The Nuremberg Code: Nuremberg
Trials, informed consent before
Nuremberg
The significance of the Nuremberg Code
Thalidomide: The Kefauver-Harris
Amendment, legal aftermaths
Declaration of Helsinki
DES: timeline, use after 1971, Sindell
vs. Abbot Labs (market share approach)
The Shadow of Thalidomide
Safety vs. Security: Hacking
pacemaker, Therac 25, Panama syrup,
cybersecurity
FDA Panels Revisit Rosiglitazone’s
Cardiovascular Safety
Pharmacovigilance system: FAERS;
comparison of UK, US and German
hospitals
Sulfanilamide Disaster
Medication errors, national plan for
ADR prevention, warfarin
Pharmacogenetics and
Pharmacogenomics Thorough
Introduction.
Robertson vs. McGee: Patients injured
in a clinical trial
US Critical infrastructure
MODULE
I
MODULE
I
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MODULE II – OPERATIONAL ENVIRONMENT
Research concepts in pharmaceutical industry
o Basic concepts in pharmaceutical research
o Types of design in clinical trials
Process timeline
o Key steps in the process of drug development
o Key steps in the process of drug commercialization
o Datasets produced in each stage of drug development
Participants and their objectives and commercial interests
o List and classification of participants and stakeholders
o Business purpose of individual participants/stakeholders
o Self-interest biases and behavior
Basic principles of GCP, GMP and GPvP
o Enforceability of these principles around the world
FURTHER READING ESSENTIAL RESOURCES
Clinical trial designs: study
designs, methods and
terminology, adaptive design
Websites of major regulators:
FDA, EMA
Clinical trial process: EudraCT
Public Report, UK CT toolkit
Drug safety reporting systems:
EudraVigilance; FAERS; Yellow Card
scheme
Research Ethics: Declaration of
Helsinki, Belmont Report, CIOMS
Human Subjects
EU Public Assessment Reports
Research metrics: success rate,
cost, speed and access to new
drugs
Databases of clinical trials:
Clinical Trials.gov (NIH) and ICTRP
(WHO)
Good Manufacturing Practice:
Inspection databases, GMP
resources
EXERCISE I: Do you know which drug
you are likely to get in a clinical trial?
Labeling: Physician Labeling Rule
EXERCISE II: How can you verify industry
claims using databases and academic
libraries?
Case study: Exubera
ASSIGNED READING:
Human on a chip
MODULE
II
MODULE
II
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MODULE III – SYSTEMIC VULNERABILITIES & RISK REDUCTION MEASURES
Participants’ objectives
System goals
Design requirements
Safety constraints
Systemic hazards
Adjudicated safety withdrawals
o UN consolidated list of withdrawals
o Major safety withdrawals 1960s-1990s
o Case studies: TGN1412, mefloquine, trovafloxacin, troglitazone,
thalidomide, diethylstilbestrol, triparanol, rosiglitazone, fen-phen
FURTHER READING ASSIGNED READING
UN Consolidated list of products
withdrwan or severely restricted
by governments
Drug toxicity: Animal toxicity tests,
predicting side effects, CDER 2001
hepatotoxicity white paper, mechanisms
Protein targets
Diethylstilbestrol: Arthur Herbst’s landmark
DES paper
Leveson: The use of STAMP in
modeling healthcare system
Mefloquine: Dr. Nevin’s presentation on
mefloquine neurotoxicity
Thalidomide The Trovan scandal: WikiLeaks Cables
Diethylstilbestrol (DES)
TeGenero lessons learned
Triparanol
Drug withdrawals worldwide – a
comparison
Mefloquine
EXERCISE:
Fen-Phen: adjudication on process timeline
Trovafloxacine
Troglitazone
Rosiglitazone
TGN1412
MODULE
III
MODULE
III
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MODULE IV – LEGAL BATTLES IN PHARMACEUTICAL INDUSTRY
Overall Trends
Federal v. State Settlements
Largest Federal Settlements
False Claims Act & Qui Tam provision
Food, Drug and Cosmetics Act
Foreign Corrupt Practices Act: Globalization & Fraud
Marketing & Advertising
FDA Marketing & Advertising
Personal Injury
Generics
FURTHER READING ASSIGNED READING
Security Class Action
Settlements
DOJ and OIG Healthcare Fraud
and Abuse Control Program
Annual Report
Federal Settlements: Highest
pharmaceutical settlements (Depakote,
Aranesp, Seroquel, Aggrenox, Azor-Benicar-
Tribenzor-Welchol, Endo Pharmaceuticals,
Risperidal, Zyprexa, Vioxx, Bextra, Hyalgan);
statistics; discussion Epstein vs. Abbott
Gibson Dunn healthcare
enforcement update
DEA Controlled Substances List
National Action Plan for Adverse
Drug Event Prevention
Landmark cases in pharmaceutical
industry:
o Dura Pharmaceuticals vs. Broudo
o Halliburton vs. EPJ Fund
o Sorrell vs. IMS Health
o Robertson vs. McGee
o Pliva vs. Mensing
o Mutual Pharm. vs. Bartlett
o Wyeth vs. Levine
o U.S. vs. Caronia
o Free Speech in pharma advertising
o U.S. rel. Ge vs. Takeda
FDA letters regarding marketing and
advertising in 2014
GSK Chinese bribery scandal
Multistate outbreak of fungal meningitis
Personal Injury Suits: Asbestos, Biomet
Bone Growth stimulants, Blood thinners,
Breast implants, Risperidal, vaginal meshes,
statins and diabetes, McKesson vaccines,
MoM hip implants, Nigerian Trovan trials,
OtisMed knee replacement, Adderall
MODULE
IV
MODULE
IV
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MODULE V – GLOBAL PHARMA GEOGRAPHY
Geography
o Big pharma headquarters
o Innovation
o Clinical research
o Regulators
o Manufacturers
o Major markets
Trends
o Globalization
o Consolidation
o Outsourcing
Pharmaceutical industry as part of critical infrastructure
Vulnerabilities
FURTHER READING ASSIGNED READING
Indian patent lawsuits
Bayer vs. Natco
Gilead vs. Natco
Merck vs. Glenmark
Roche vs. Cipla
Novartis vs. Union of India
Innovation:
Special 301 Report 2014 and 2015
Case study: Exubera
Innovation:
TRIPS Amendment
Regulators:
Extraterritorial FDA
Consistency of EU safety communications
Chinese FDA
Innovation:
WTO Paragraph 6
Consolidation:
Pfizer bid on Astra Zeneca
Critical infrastructure:
Healthcare spending
Critical infrastructure: US vs. Europe
Strategic dependencies:
Foreign sourced vs. imported drugs
MODULE
V
MODULE
V