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.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
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.
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
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.
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
Just to remind you that registrations for our 18th Pharmacovigilance 2019 event, which is taking place at The Pestana Chelsea Bridge Hotel in London, UK on 27-28th Feb are closing soon.For more details email to dinesh@virtueinsightsummits.com
Dr. Samuel Dyer will be moderating the 2nd Annual Medical Affairs Leaders Forum Asia in Hong Kong on August 5th-6th, 2014.
Dr. Samuel Dyer will also be speaking at the event and will represent the Medical Science Liaison Society.
Preparing for a New Time in Medical Literature MonitoringCovance
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
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.
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
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.
Assignment Steps Resources Tutorial help on Excel® and Word fun.docxlynettearnold46882
Assignment Steps
Resources: Tutorial help on Excel® and Word functions can be found on the Microsoft® Office website. There are also additional tutorials via the web offering support for Office products.
Scenario: Imagine you are a business consultant to a firm of your choice. You have been asked to analyze, advise, and create recommendations on how the firm can ensure its future success in its current market.
Work with your instructor to choose a firm that matches the following criteria: a publicly-traded company operating in the U.S. market. Note: A publicly-traded company is a private-sector firm owned by its shareholders/stock holders.
Prepare a minimum 1,050-word analysis of economic data and business data to explain how the core economic principles impact the sustainability of the firm and what actions the firm can take to ensure success.
Address the following:
· Identify the market structure your chosen firm operates in, analyze your chosen firm's current market share, and identify the firm's local/global competitors. Analyze the barriers to entry in this market to illustrate the potential for new competition and its impact on your firm's future in the market. Hints: Be sure you review the barriers to entry discussed in the course text. You might consider presenting the data graphically.
· Identify and explain trends in current macroeconomic indicators for last three years including:
· Current stage of the business cycle.
· Real gross domestic product (GDP).
· Inflation as measured by the consumer price index (CPI).
· Unemployment rate.
· Federal funds rate.
· Current rate for borrowing funds such as the so-called "prime rate." Note: A requirement of the Week 1 Influence of Economics on Household Decision Making report was to gather data on the CPI, GDP, and interest rates, so you should consider reviewing the feedback you received on the Week 1 report.
· Evaluate trends in demand over last three years and explain their impact on the industry and the firm. Include quarterly (last two quarters) and annual sales (last three years) figures for the product your firm sells. Create business strategies by analyzing information and data related to the demand for and supply of your firm's product(s) to support your recommendation for the firm's actions. Remember to include a graphical representation of the data and information used in your analysis.
· Examine available, current data and information, such as pricing and the availability of substitutes, and explain how you could determine the price elasticity of demand for your firm's product. Assess how the price elasticity of demand impacts the firm's pricing decisions and revenue growth.
· Apply the concepts of variable and fixed costs to your firm for informing its output decisions. For instance, analyze how different kinds of costs (labor, research and development, raw materials) affect the firm's level of output.
· Based on the data gathered and analysis performed for this report write a .
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.
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.
VAERS Explorer https://www.aretezoe.com/vaers-explorer
You can follow VAERS Explorer on social media:
Facebook: https://www.facebook.com/VAERSExplorer/
LinkedIn: https://www.linkedin.com/showcase/vaers-explorer/
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Parler: https://parler.com/VAERSExplorer
YouTube: https://www.youtube.com/playlist?list=PLB6cShh65rNpo1dHiAQJ3-QEHyyM9zSJ1
Rumble: https://rumble.com/user/VAERSExplorer
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
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention
First published April 2017
Part of test scenarios for implementation of new sepsis guidelines
buy old yahoo accounts buy yahoo accountsSusan Laney
As a business owner, I understand the importance of having a strong online presence and leveraging various digital platforms to reach and engage with your target audience. One often overlooked yet highly valuable asset in this regard is the humble Yahoo account. While many may perceive Yahoo as a relic of the past, the truth is that these accounts still hold immense potential for businesses of all sizes.
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
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Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfthesiliconleaders
In the recent edition, The 10 Most Influential Leaders Guiding Corporate Evolution, 2024, The Silicon Leaders magazine gladly features Dejan Štancer, President of the Global Chamber of Business Leaders (GCBL), along with other leaders.
FIA officials brutally tortured innocent and snatched 200 Bitcoins of worth 4...jamalseoexpert1978
Farman Ayaz Khattak and Ehtesham Matloob are government officials in CTW Counter terrorism wing Islamabad, in Federal Investigation Agency FIA Headquarters. CTW and FIA kidnapped crypto currency owner from Islamabad and snatched 200 Bitcoins those worth of 4 billion rupees in Pakistan currency. There is not Cryptocurrency Regulations in Pakistan & CTW is official dacoit and stealing digital assets from the innocent crypto holders and making fake cases of terrorism to keep them silent.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
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3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Pharmaceutical Supply Chain Integrity and Security (2016)
1. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
COURSE SYLLABUS
Course Title: Pharmaceutical Supply Chain Integrity and Security
Instructor: Arete-Zoe
Delivery method: Indirect (Internet)
Length: 6 hours and 40 minutes of video content
Estimated study time: 1 month
CPE credits: n/a
Catalog Description:
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.
Instructor comments:
Each chapter contains a Study Guide with assigned readings (mandatory) and suggested readings
(recommended) and a list relevant databases and registries. Understanding the terminology is essential
to appreciate the differences in concepts that shape national and supra-national regulatory policies.
Students are encouraged to explore and review provided suggested readings to appreciate complexity
and extent of the topic in question. All selected materials are available in public domain free of charge.
For Interactive case studies, students are asked to conduct own research into examples of
pharmaceutical supply chain disruptions and vulnerable shipping routes. Quiz is included in each chapter
to facilitate understanding and knowledge retention.
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
1 of 14
2. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
BROAD COMPETENCIES AND TERMINAL OBJECTIVES:
Explain driving forces and influences that shape regulatory environment and policy in regions most
relevant to global pharmaceutical supply chain.
Describe operational environment in pharmaceutical industry as defined by national and supra-
national standards in the U.S., EU, Japan, India, and China.
Compare operational environment in major pharma manufacturing countries and regulated markets
with that in Russia, Middle East, Latin America and sub-Saharan Africa.
Describe main changes and principles introduced by new legislation in the U.S. and in Europe relating
to traceability and authentication of medicinal products throughout the whole supply chain.
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 pharmaceutical product counterfeiting and intellectual property
infringements.
Appreciate the disparity between national enforcement systems and global nature of pharmaceutical
industry, as well as FDA enforcement efforts at home and abroad
Become familiar with information available in databases and registries.
Explain structural change and consolidation of pharmaceutical industry since the 1990s
Discuss geographical realities of current operational environment of pharmaceutical manufacturing,
shipping and consumption
Analyze trends in maritime piracy, describe methods used and explain financial consequences
Discuss characteristics of Chinese market and manufacturing, barriers to entry, enforcement
challenges and recent efforts to improve the country’s product safety record
Explain the nature of pharmaceutical supply chain vulnerabilities, namely sole source supply chain,
lean operations, internal and external interdependencies, and increase in complexity
Understand the nature of threats such as compliance failures, accidents, incompetence, corruption,
business competition, criminal interest, severe weather and civil disruption
Discuss drug shortages and diversion, their causes and measures taken to tackle them
Discuss the role of leadership in awareness of vulnerabilities and threats and the importance of
clearly defined priorities such as PIR, KPI, R&R and relationships
Discuss pharmaceutical cargo thefts, high-risk areas, methods and countermeasures, monitoring and
reporting, direct and indirect losses, and public health implications of resale of stolen drugs
Describe U.S. and international programs implemented to protect cargo shipped by air
Summarize measures taken in the U.S. to tackle drug shortages as defined in the EO 13588 of 2011
and Title VII and X of FDASIA and discuss current shortages and related price gauging
Explain how drug supply chain information management systems bridge disparate systems
Discuss how data breaches affect pharmaceutical supply chain
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
2 of 14
3. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
Course Material List:
Required: None, all necessary materials are linked to each chapter. 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: Suggested 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.
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
3 of 14
4. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
COURSE BREAKDOWN
Contents
COURSE SYLLABUS......................................................................................................................................... 1
BROAD COMPETENCIES AND TERMINAL OBJECTIVES: ................................................................................. 2
COURSE BREAKDOWN................................................................................................................................... 4
INTRODUCTION ............................................................................................................................................. 5
REGULATIONS IN THE U.S.............................................................................................................................. 6
REGULATIONS IN THE EU............................................................................................................................... 7
REGULATIONS IN MAJOR ASIAN ECONOMIES............................................................................................... 8
INTERNATIONAL STANDARDS ....................................................................................................................... 9
ENFORCEMENT............................................................................................................................................ 10
GLOBALIZATION........................................................................................................................................... 11
SUPPLY CHAIN INTEGRITY AND SECURITY................................................................................................... 12
CASE STUDIES .............................................................................................................................................. 13
SUMMARY ................................................................................................................................................... 14
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
4 of 14
5. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
INTRODUCTION
Pharmaceutical supply chains are becoming more and more complex due to globalization, shift of
manufacturing and business operations to Asia, and due to complex relationships between vendors and
supply chain partners. Good distribution practices are an important part of the whole system of
appropriate supply chain management. Recently introduced legislation in the U.S. and in Europe brings
major changes in the management of pharmaceutical supply chains, increasing the level of control over
all parts of the process, eventually leading to the creation of repositories, complex identification and
authentication systems, and introduction of interoperable track-and-trace systems. Introductory chapter
outlines regulations and guidelines that govern the industry in the U.S., European Union, and in major
Asian economies such as Japan, India and China. Russia is included to explain its unique approach to
pharmaceutical supply chain security. Differences between major markets and jurisdictions include lack
of consensus on the definition of counterfeit, misbranded, adulterated or falsified drug, thresholds for
their detection, identification requirements, and track-and-trace methods and obligations.
Chapter Activities:
Brief video presentation outlines content of the course and summarizes main talking points for each
chapter in order to facilitate orientation throughout the course.
Reading Assignment: n/a
Further Readings: n/a
Evaluation: n/a
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
5 of 14
6. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
REGULATIONS IN THE U.S.
The U.S. regulatory environment evolved into its current form due to accidents, political battles over
new laws and court decisions that often overturned the legislators’ intent. Brief historical excursions are
included to illustrate how the system came into existence. Overview of the U.S. regulatory system starts
with the Drug Importation Act of 1848 and continues with the early 20th
century battles over the 1906
and 1938 legislation, and changes forced by legal battles and major incidents. The introduction of major
changes, such as the Federal Anti-Tampering Act of 1982 and the Prescription Drug Marketing Act
(PDMA) of 1987 is presented in the context of situations these new laws were supposed to resolve.
Major changes in the U.S. system of control of pharmaceutical supply chain were introduced after the
9/11 terrorist attacks. Significant attention is devoted to Good Distribution Practice guideline USP 1083
and key piece of the current legislation, Title II of the Drug Quality and Security Act (DQSA) of 2013, the
Drug Supply Chain Security Act.
Chapter Objectives:
By the end of this chapter, students will be able to:
Describe the first attempts to stop influx of adulterated and bogus drugs in the U.S.
Compare public awareness and priorities of major stakeholders during drafting and arguing
legislative changes in in 1906 and 1938.
Explain the impact of Elixir sulfanilamide disaster on introduction of the Federal Food Drug and
Cosmetics Act of 1938, and describe how and on what grounds the product was recalled
Discuss the origin of the Federal Anti-Tampering act of 1983
Elaborate on measures designed to discourage the sale of counterfeit pharmaceuticals as
introduced by the PDMA, and explain what situation this law was supposed to resolve
Describe main principles of good distribution practice defined in the USP guideline <1083>
Define risks to the integrity of products entering the supply chain
Formulate key steps of a response to suspected presence of counterfeit products.
Outline critical steps to build a system defined in the DSCSA
Discuss anti-terrorism legislation and programs that affect pharmaceutical supply chain.
Module Activities:
The chapter material contains 12 short video presentations, glossary of essential terminology, and a
Study Guide. Assigned readings include full text of the relevant legislation, relevant summary articles,
and links to resources and databases and other relevant materials. Comprehension quiz is part of the
chapter.
Reading Assignment: See Study Guide
Further reading: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
6 of 14
7. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
REGULATIONS IN THE EU
European system was designed to facilitate the establishment of European internal market without
internal frontiers. It also accommodates experiences from events that occurred in the individual member
states, in the United States and elsewhere. The first piece of legislation at EU level, Directive 92/25/EEC,
introduced the definition of wholesale distribution and public service obligation of wholesalers. Directive
2001/83/EC, amended by the Falsified Medicines Directive of 2011, is the core piece of pharmaceutical
legislation in the European Union. Obligations include the need to exercise control over the entire chain
of distribution, to limit distribution only to medicinal products authorized in the EU, and to ensure their
traceability. Regulation 726/2004 then adds provisions on parallel distribution. The current version of
Good Distribution Practice guidelines of 2013 is discussed in detail to provide thorough understanding of
the current requirements on the distribution of pharmaceuticals in the European Union. The long
awaited Delegated Act of 2015 describes safety features on pharmaceutical packaging and future means
of verification of authenticity of unique identifiers.
Chapter Objectives:
By end of this chapter, students will be able to:
Explain how EU level legislation applies in individual Member States.
Describe the most important drivers in implementation of new EU pharmaceutical legislation.
Explain how incidents that occurred outside Europe such as the 1982 Tylenol murders or the
2008 Heparin incident triggered changes in European pharmaceutical legislation.
Describe main principles of pharmaceutical distribution introduced by Directive 2001/83/EC as
amended by the Falsified Medicines Directive of 2011.
Describe main principles defined in the Good Distribution Practice Guideline of 2013
Describe what information is available in EudraGMDP, and define limitations of this database.
Compare public service obligations of pharmaceutical wholesalers in the U.S. and in Europe.
Compare availability of pharmaceutical products in online pharmacies in the U.S. and in Europe.
Compare rules on pharmaceutical advertising in the U.S. and in Europe.
Explain the principle of parallel imports of medicinal products within the EU.
Explain changes introduced by the Delegated Act of 2015
Module Activities:
The chapter material contains 16 short video presentations, glossary of essential terminology, and a
Study Guide with links to assigned and further readings. Assigned readings include full text of the
relevant legislation, relevant summary articles, and links to resources and databases and other relevant
materials. Comprehension quiz is included.
Reading Assignment: See Study Guide
Further reading: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
7 of 14
8. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
REGULATIONS IN MAJOR ASIAN ECONOMIES
Major Asian economies, such as China, India and Japan, have a unique role in the global pharmaceutical
supply chain. Japan is a party to the International Conference on Harmonization (ICH), and adopts its
standards as approved by the Tripartite. Five of the top 25 global brand manufacturers come from Japan.
India, as a major pharmaceutical manufacturer, adopted WHO guideline on good distribution practices
with minimum changes. Major share of Indian Pharma products is exported to highly regulated markets.
In January 2013, Chinese Ministry of Health published the revised Good Supply Practice for
Pharmaceutical Products. The guidelines are very detailed and follow the same principles as other
comparable standards. The FDA is very active in enforcing compliance of plants that import
pharmaceuticals to the U.S. Patent and copyright law and policies in India and China are a good example
of substantial differences in understanding of the definition of counterfeit, falsified, misbranded and
substandard products. Before the war in Ukraine, Russia was still one of the emerging markets. Russia
is a major market for counterfeit pharmaceuticals that are available through online pharmacies. New
Russian legislation criminalized pharmaceutical counterfeiting as well as the distribution of fake and
adulterated medicines.
Chapter Objectives:
By the end of this chapter, students will be able to:
Describe the regulatory environment in Japan.
Compare pharmaceutical manufacturing in Japan, India and China.
Define share of total volume of pharmaceuticals produced in India and China in global context.
Identify the main source countries of counterfeit pharmaceuticals
Discuss legislation that governs distribution of pharmaceuticals in India
Discuss legislation that governs distribution of pharmaceuticals in China
Explain why India, China and Russia are included on the IPR Priority Watch List
Compare Russian regulatory environment with that of other major markets.
Explain how the FDA enforces quality standards of imported pharmaceuticals.
Module Activities:
The chapter material contains 7 short video presentations, glossary of essential terminology, and a Study
Guide. Assigned readings include relevant legislation, summary articles, and links to resources and
databases and other materials. Comprehension quiz is part of the chapter.
Reading Assignment: See Study Guide
Further reading: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
8 of 14
9. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
INTERNATIONAL STANDARDS
The global regulatory environment in good distribution practice and supply chain integrity and security is
very complex and continuously evolving. The provided overview of regulations and guidelines in the U.S.,
European Union, Japan, India, China and Russia, as well as international standards, illustrates complexity
of the international regulatory environment, and constant need to keep up with all the changes and
amendments. Every country has a set of national legally binding rules, which need to be translated into
corporate internal procedures without hindering the overall effectiveness of the system. Challenges
relating to trademark counterfeiting, traceability capabilities and consistency of regulatory response and
enforcement may be local, but the impact on supply chain integrity and security is always global.
Understanding of Intellectual property rights and patent law differs significantly around the globe.
Countries such as India and China are often associated with infringement of intellectual property rights
and trademark counterfeiting.
Chapter Objectives:
By the end of this chapter, students will be able to:
Describe the main areas covered by the WHO good distribution practice guidelines
Define the origin and purpose of taskforce IMPACT
Explain the applicability of WHO guidelines at national level
Explain the purpose and scope of the Medicrime Convention
Module Activities:
The chapter material contains 3 short video presentations, glossary of essential terminology, and a Study
Guide with links to assigned and further readings. Assigned readings include legislation, summary
articles, and links to resources and databases and other relevant materials. Comprehension quiz is part
of the chapter.
Reading Assignment: See Study Guide
Further reading: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
9 of 14
10. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
ENFORCEMENT
Recently introduced legislation in the U.S. and in Europe brings major changes in the management of
pharmaceutical supply chains. These measures also introduce new vulnerabilities especially in the
information management domain. Profound changes in the pharma industry, such as consolidation,
globalization, and outsourcing, together with shift of business-critical operations to Asia create multiple
systemic vulnerabilities. Pharmaceutical products from India and China account for vast majority of
counterfeit products. Drug counterfeiting is highly profitable, with low penalties compared to trafficking
narcotics. The counterfeit drug problem has worsened over the last decade, due to larger, more complex
supply chains; more customers reachable through the Internet; international nature of these crimes; and
the expansion of counterfeiting from lifestyle drugs into therapeutic medicines.
Chapter Objectives:
By the end of this chapter, students will be able to:
Appreciate the disparity between national enforcement systems and global nature of
pharmaceutical industry, as well as reliance of regulated markets on their partners in Asia
Find information on FDA inspections at home and abroad and locate wholesaler registries
Explain the origin and purpose of IWG on Import Safety and mention major operations
Appreciate the difference in penalties for trafficking narcotics and selling counterfeit medicines
Discuss 2005 and 2014 Congressional hearings on counterfeit drugs and illegal supply chains
Explain the differences between perception of counterfeit drugs by the public and reality
Discuss relevant findings from the 2014 EU Customs report on IPR enforcement
Analyze information available in the EudraGMDP database, namely issued Wholesale
Distribution Authorizations, Good Distribution Practice Certificates, and non-compliance reports
Explain what information can be found in EDQM databases and use EDQM Certification database
Discuss incidents of counterfeit prescription drugs such as the Lipitor recall and Canada Drugs
Explain the nature and purpose of operation Pangea
Explain the difference between foreign-sourced and foreign-made drugs and discuss why
exclusive production of these drugs in India and China becomes a security concern
Summarize most important steps taken by China to improve product safety and fight corruption
Describe challenges experienced by poor countries on the example of Afghanistan
Describe the role of DEA with regards to diversion of controlled substances
List UN Drug Control Conventions and relevant international treaties
Describe precautions prescribers should take to prevent diversion of Rx drugs for illicit purpose
Chapter Activities:
Watch 17 brief video presentations
Reading Assignment: See Study Guide
Further Readings: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
10 of 14
11. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
GLOBALIZATION
Pharmaceutical industry is global in nature. Corporate operations typically span multiple jurisdictions and
several continents. Pharmaceutical supply chains are becoming more and more complex due shift of
manufacturing and business operations to Asia, and because of outsourcing. The distance between
manufacturing sites and markets, as well as complexity of the entire operation, creates numerous
vulnerabilities with potentially high impact for organizations and their customers. The current geography
of pharmaceutical manufacturing and markets is the result of long-term trends. Companies are growing
in size due to acquisitions and mergers. Corporations take advantage of lower prices in developing
countries and outsource their operations to low-cost countries to achieve better return on investment.
Location of manufacturing centers and major markets determines which shipping routes are used, and
which piracy hotspots are likely to become an issue.
Chapter Objectives:
By the end of this chapter, students will be able to:
Describe how trends in the shipping industry affect long-distance transport of pharmaceuticals
Find sea routes used for shipping of APIs and drugs and locate relevant choke points and straits
Discuss location of major markets and manufacturing centers
Describe FDA enforcement efforts abroad
Analyze available data on value and volume of pharmaceuticals including market segments
Define major causes of supply chain disruptions
Explain most important characteristics of European pharmaceutical market such development of
trade balance, insurance payments, registered foreign manufacturers and parallel trade
Describe what makes Chinese market so attractive and what are the barriers to entry
Explain structural change and consolidation of pharmaceutical industry since the 1990s
Describe long-term and latest trends in pharmaceutical mergers and acquisitions
Explain what makes pharmaceutical supply chains so vulnerable to disruptions
Define most relevant drivers of outsourcing of key operations
Discuss current drug shortages in the U.S. and in Europe
Discuss the impact of big industrial accidents such as the one in Tianjin, China
Discuss trends in the shipping industry such as vessel size, accident rate and manning
Analyze trends in maritime piracy, describe methods used and explain financial consequences
Describe the causes of main supply chain disruptions such as drug shortages and diversion
Chapter Activities:
Watch 8 brief video presentations
Reading Assignment: See Study Guide
Further Readings: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
11 of 14
12. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
SUPPLY CHAIN INTEGRITY AND SECURITY
Risks of administrative, civil or criminal action resulting from non-compliance are not the only risks
enterprises involved in pharmaceutical supply chain face. Other vulnerabilities, such as internal and
external interdependencies, sole source supply chain, personnel turbulence, over-specialization and lean
operations also create an opportunity for exploitation by threat actors. Compliance failures are only one
category of such threat. Accidents, incompetence and corruption, business sector competitors, criminal
interest, civil disruption, severe weather and natural disasters, and war can all affect enterprises one way
or the other. Adverse consequences include loss of litigation, denial of market access, consumer
rejection, compromised intellectual property or data breach.
Chapter Objectives:
By end of this chapter, the student will be able to:
Appreciate the nature of pharmaceutical supply chain vulnerabilities, namely sole source supply
chain, lean operations, internal and external interdependencies, and increase in complexity
Understand the nature of threats such as compliance failures, accidents, incompetence,
corruption, business competition, criminal interest, severe weather and civil disruption
Discuss the role of leadership in awareness of vulnerabilities and threats
Discuss the importance of clearly defined priorities such as priority information requirements,
key performance indicators, relationships and roles and responsibilities
Explain direct and indirect losses caused by theft of pharmaceutical cargo
Discuss the causes and consequences of underreporting cargo thefts in Europe
Pinpoint locations with the highest risk of cargo theft and discuss methods used in each area
Describe U.S. and international programs implemented to protect cargo shipped by air
Summarize measures taken in the U.S. to tackle drug shortages as defined in the EO 13588 of
2011 and Title VII and X of FDASIA
Discuss current drug shortages in the U.S. and related price gauging
Discuss WHO recommendations regarding global shortages of essential medicines
Compare measures implemented to tackle drug shortages in the U.S. and in Europe
Explain how drug supply chain information management systems bridge disparate systems and
standards adopted by different industries in multiple countries
Analyze data from DHHS Data Breach Portal and comment on data breach trends
Discuss observations described in important data breach reports published by Verizon,
Ponemon, Deloitte and Norton
Chapter Activities:
Watch 9 brief video presentations
Reading Assignment: See Study Guide
Further Readings: See Study Guide
Evaluation: Comprehension quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
12 of 14
13. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
CASE STUDIES
Interactive case studies are included to show variety of incidents that occurred in the industry and
resulted in adverse consequence. All use cases were widely publicized. Students are expected to
conduct their own research and answer questions as presented. Hints may point directly to the
source or refer to study guides, as appropriate.
Pharmaceutical Supply Chain Disruptions
Students will be asked to research and review the following incidents:
Adulterated heparin
1080 infant formula scare
Toxic capsules manufactured in China
Canada Drugs
$80 million burglary
Tianjin blast
Fake Lipitor
Cobalt 60 theft
Shipping routes
Students will be asked to research the following geographical areas:
Gibraltar
Eastern Mediterranean
The Strait of Malacca and the Singapore Strait
Horn of Africa
Panama Canal
South China Sea
Strait of Hormuz
Suez Canal
Chapter Activities:
Individual research into specific incidents of supply chain disruptions
Individual research into shipping routes
Further Readings: See Study Guide
Evaluation: Interactive quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
13 of 14
14. Pharmaceutical Supply Chain Integrity and Security
Pharma supply chain regulations in the U.S., Europe, Japan, India and China; enforcement, globalization and
pharmaceutical supply chain security and integrity.
Arete-Zoe, LLC Address: 1334 E Chandler Blvd 5A-19 Phoenix 85048 AZ, USA | T: +1-480-409-0778 | http://aretezoe.com
SUMMARY
The main takeaway points can be found in downloadable pdf summaries.
Regulations in the U.S.
Regulations in the EU
Regulations in major Asian economies
International standards
Enforcement
Globalization
Supply Chain Security & Integrity
Bibliography
Chapter Activities:
Individual research into specific incidents of supply chain disruptions
Individual research into shipping routes
Further Readings: See Summaries
Evaluation: Interactive quiz
Published: September 2016 ARETE-ZOE, LLC
Registered address: Phoenix, AZ, USA. Correspondence address: Lakewood, WA, USA
https://www.aretezoe.com/
14 of 14