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Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

Hepatitis and Hepatitis C are two of the most common forms of hepatitis and both are caused by different viral strains. Various companies are involved in developing a new drug for treating Hepatitis C due to the growing patient pool. The disease is caused by a virus that can be transmitted from person to person and can be acquired either through ingesting an infected person's blood or inhaling their infected air. Hepatitis is caused by a strain of the virus which is not transmitted from one person to another and is caused by a genetic defect. Hepatitis is caused by the human papillomavirus (HPV), while hepatitis C is caused by a variety of different strains of the virus called HCV. Hepatitis can be caused by a single strain of the virus, although some cases have been known to be caused by multiple strains. It is also possible for a person to contract one form of the virus, then develop a secondary infection which is caused by another form of the virus. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/hepatitis-c-drug-is-gaining-prominence.html

Opioids agonist drugs are a group of powerful and widely used drugs that alleviate the pain of moderate to severe chronic pain by reducing the impact of narcotic receptors in the brain. These include both codeine and hydrocodone, the most common opioids. Although they relieve pain, they have serious side effects that include drowsiness, respiratory depression, dizziness, nausea, and sweating. These drugs are very powerful, so overdoses are common, and death from them is even more common. This group of drugs has received heavy criticism from both patients and doctors alike for the risks involved in using them. The opioid antagonist hydrocodone works by blocking the opioid receptors in the body. Codeine is the only opioid that does this in a pure form. Because hydrocodone blocks the opioid receptors in the brain, it becomes less available to people who take it. This opioid group is popular among heroin abusers, since heroin creates a euphoric state that cannot be reproduced with hydrocodone. For this reason, heroin abusers frequently turn to other forms of treatment, such as prescription medications and methadone. Other opioids agonist drugs in this group include oxycodone, hydromorphone (Percoset), hydromorphone hydrochloride (hydrocodone), and methadone. Taking them is not without dangers though. Oxycodone has caused at least five deaths and several dozen hospital admissions in the US since 1999. In extremely rare cases, people have died of overdosing on hydrocodone. Heroin abusers also regularly take this drug, since it can suppress their desire for heroin. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/02/emergence-of-covid-19-and-increasing.html

Stomach cancer is a growth of abnormal tissues that form a tumor in the part of your abdomen. Symptoms of stomach cancer often include persistent abdominal pain, extreme heartburn, extreme vomiting, severe indigestion, abdominal swelling, and frequent diarrhea. These symptoms are common for all forms of stomach cancer but when cancer spreads to the upper part of the chest, the symptoms become far more severe and may eventually cause death. Stomach cancer has the highest survival rate of any type of cancer in the world. Crocetin (trade name Eulexin) is the first Stomach Cancer Drug that is used in the treatment of gastric cancer. It was later on approved for treating peritoneal mesothelioma but was not marketed extensively due to its negative outcomes at the beginning. The increasing prevalence of stomach cancer is expected to drive growth of the global stomach cancer drugs market during the forecast period. According to the American Cancer Society (ACS), in 2020, around 27,600 new cases of stomach cancer are expected to be diagnosed in the U.S. According to the World Cancer Research Fund, in 2018, over 1 million new cases of cancer were diagnosed across the globe. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/stomach-cancer-drugs-market-continues.html

A pharmaceutical drug is a chemical substance that is used to cure, diagnose, treat, or protect disease. Some pharmaceutical drugs are sold in pharmacies and some are sold over-the-counter or as over-the-counter medications. Prescription drugs have many different applications, including the treatment of certain illnesses, but they also come in various forms that range from capsules, tablets, liquids, and lotions. One of the most popular and major types of pharmaceutical drugs is the oral form. These are drugs that can be taken by swallowing, which means that they need to pass through the stomach into the upper intestines where they are metabolized and digested into other substances. It is important to note that a certain amount of stomach acid is normal in the intestines and it helps digest food. Another popular type of pharmaceutical drug is an injectable. These are available as intravenous fluids and can be injected into a vein or through a catheter to deliver drugs to the body. Many people opt for these drugs because of their convenience and ability to be delivered right to where they need it. There are also synthetic drugs that can be used to treat many of the problems faced by the body. These drugs are sometimes more expensive than the ones prescribed from a doctor but are considered to be safer since they do not have as many side effects. Also, some of these drugs are more reliable than the prescription medication provided by a doctor. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/emergence-of-covid-19-adversely-impacts.html

High purity alumina (HPA) is a high-purity form of aluminum oxide. It is majorly used in production of synthetic sapphire, LED lighting, lithium ion batteries, plasma display screen, photovoltaic cells, sodium lamps, phosphor, and optical lenses. It is homogeneous crystal in structure and is obtained by aluminum alkoxide hydrolysis process. There are three grades of alumina. One of these is called "high purity alumina", and it can be manufactured using different methods. In fact, the most commonly used alumina is the "super alumina". This is produced in a high pressure process using steam under a pressure of 2.7 bar. This type of alumina is extremely tough as it is made from pure alumina powder. Another type of alumina is "low-pressure alumina and "high-pressure alumina". This type is very strong and requires high pressure in order to get its properties. It is usually formed in a separate high pressure furnace. It is very strong and can withstand corrosion and rust. There are many benefits of alumina. It is very suitable for a wide range of applications. It can withstand corrosion and is very easy to clean and maintain. All these factors make alumina a perfect choice for a wide range of industrial uses. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/increasing-adoption-of-smartphones-to.html

The process of sterilization and disinfection has always been crucial in maintaining optimum hygiene in any given setting. However, the ongoing COVID-19 pandemic has heightened the importance of these processes. Sterilization refers to any process that removes, eradicates, or kills all forms of life particularly, fungi, bacteria, viruses, spores, etc. Sterilization equipment and disinfectants are crucial in modern medical care as patients come in contact with syringes, surgical tools, and bandages all time. These medical devices eliminate any foreign particles, pus, blood, and dirt left behind that could create complications for the next patient requiring surgery. Besides, it decreases bioburden and prevents corrosion of expensive and highly precise tools. There are different sterilization processes performed including steam sterilizing, flash sterilizing, low-temperature sterilizing, hydrogen peroxide gas plasma, ethylene oxide gas sterilization, peracetic acid sterilization, etc. Many regulatory authorities have issued guidelines on how to sterilize medical equipment. The hospitals refer to it as a germ warfare strategy and it is done in a specific order. The first step is cleaning followed by disinfection which involves using liquid chemicals to kill non-spore-forming bacteria. The final step is sterilizing where several methods are employed to kill disease-causing microorganisms and also eradicate transmissible agents such as spores and bacteria. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/sterilization-equipment-and.html

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

Do you have anything that is less fattening; you see I'm on a diet. This is a classic statement most of the dieters say. Dieting has become a rage in this era of health consciousness. People unlike before have become very particular about their calorie intake, food they eat and the amount of fat that they consume. Diet is a regulated selection of foods usually done due to medical or cosmetic reasons. Dieting is a form of losing weight by cutting down the fat content in the daily food consumption.

Understanding Medical Identity Theft and ways of preventing it Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry. medicalIdentityTheft The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to impersonate and manipulate data. Why do crooks steal medical data? Medical Identity Theft happens mainly because hackers and mischief-makers access protected data to lay hands on confidential information about patients, using which they obtain medical care on behalf of the person/s whose records they steal or purchase expensive medicines. In many cases, a Medical Identity Theft is detected only after one gets a bill for a purchase or service that was never made. medicalIdentityTheft Medical Identity Theft is also committed to buy drugs and obtain fake bills that are then submitted to Medicare in the name of the original holder of the medical record. These acts can significantly dent a person's credit rating. More importantly, when wrong information or fictitious diagnosis is made into the medical record, it can lead to dangerous consequences. Ways of protection of medical data The Office of the Inspector General (OIG), which comes under Health and Human Services (HHS), realizing the gravity of the problem of Medical Identity Theft, has formulated the "3D" approach to protect medical data and prevent Medical Identity Theft. These are: Deter: One of the ways of protecting medical data is to prevent Medical Identity Theft. Users should be cautious about parting with information to anyone who claims, over phone, to have a new scheme whose enrolment requires the Social Security Number. Detect:Many fraudsters accost people at accessible public places to announce supposedly "new" medical schemes. Governm

What is Corporate Governance? In a broad sense, corporate governance can be defined as a set of processes by which corporations are run and administered. These are a collective function of the critical, core decision makers in the organization, such as Directors, CEO, managers, investors, stakeholders, shareholders, creditors, auditors and others. Corporate Governance sets out the methods and rules for making rules that govern corporate entities. Although business is the main concern and task of an organization, Corporate Governance occupies as important a position, because while the financial aspect of a business is all about profits, the Corporate Governance aspect is primarily about its integrity, values and reputation. Corporate Governance takes into consideration all aspects of the governance of the organization from critical standpoints such as ethics, regulatory aspects, policies and mission, etc. History of the growth of Corporate Governance Although Corporate Governance has been around for a number of decades in some or another form, it came to acquire proper shape and direction of late, following the collapse of very big multinationals such as Enron, WorldCom and others. It was felt that their shady dealings, which led to huge losses for their stakeholders and eventually to the businesses collapse, could have been averted if a proper regulatory framework of Corporate Governance were in place. This is the feeling that led to the passing of the Sarbanes Oxley Act, or SOX in the early 2000's. One of the core principles enunciated in SOX related to Corporate Governance. Elements of Corporate Governance As a result of the SOX Act and other legislations in other developed countries, such as the Cadbury Report of the UK and other legislations in the OECD nations; Corporate Governance is now administered through a well-defined set of principles. As a result of these legislations, Corporate Governance is now concerned with the following: Problems areas of Co

Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

Food Safety and Security are two faces of the coin : Food safety and security are two different, but closely related concepts. Although part of the same aspect, they vary in their application and meaning. Both are equally important in ensuring that populations of the world get food that is sufficient and nutritious. Food safety and security are complete without each other. Food safety complements food security, and vice versa. Food safety : Food safety is essentially about the safety of the ingredients that go into food. If food is being sourced from a farm, the food makers have to ensure that the farm has ensured safety standards in producing this food. Food safety is concerned about the amount of chemicals and fertilizers used in production of food. It is also concerned with how much residual pesticide, which could cause harm to humans when the food that is grown using it, is left in the final product, and so on. Food safety is related to and is dependent on factors such as demographics, inputs that go into the cultivation and production of food, availability of water for production of safe food, the use of energy sources in the safe production of food, climate change, etc. Now, food security : Food security, on the other hand, is about more about the food supply chain. When food arrives from the producer to the consumer, it goes through a complex chain that can many times span entire continents. Food may also be sourced and consumed locally. In either case, there is a need to ensure that the points that food travels in and reaches are secure. Ensuring quality throughout : The aim of food security is to ensure that food which travels through many chains and stages should be clean at all these stages. This means that security has to be ensured from rodents and other forms of disturbances at the agricultural fields in which food is produced, then at the granaries in which it is stored, at the routes that it travels, then at the location at which food is pr

Overview: The connection between the Body, its physiology and particularly biochemistry, have been linked to the mind with particular emphasis upon emotions and stress. This can be easily substantiated in common everyday situations. Anyone who has observed a facial red flush triggered by some sort of embarrassment can attest to the foregoing connection. The emotions and stress play a key role in many if not all diseases and disorders: due to the vastness of the subject, we will focus on the application of the mind/body connection(MBC) to skin. This serves as an introduction to the field of psych dermatology which, although still in its infancy in the USA, is expanding as evidence with regard to the psychological component related to the etiology of skin diseases continues to grow. Concurrently, the field of Alternative techniques IN mind/body treatments continue to grow in leaps and bounds providing effective methods for integration with conventional cosmetic and dermaceutical treatment. This provides a dual complimentary pathway both for prevention and treatment of any/most skin disorders. Expanding on this model, we have already shown how the mind influences the body as per the above example. This general proposition can be extended to include specific skin disorders such as acne rosacea psoriasis eczema and atopic dermatitis to name a few. We will concentrate on Acne for the sake of this discussion. First, focusing on the B component of the BMC model, the primary lesion associated with acne is the formation microcomodones, which are small enough to proceed undetected until larger comodones appear later in the cycle. The latter cycle is initiated by peroxidation of squalene and unsaturated fatty acids present in human sebum. This leads to the foregoing lesions and pro- inflammatory mediators such as cytokines and interleukins followed by an increase of p.acnes on the epithelial cell wall together with increased film formation of the p.acnes is the same area This

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

The emerging discipline of Hospitals Management Performance Assessments Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics to evaluate the critical functioning levels of hospitals. The topic of Hospitals Management Performance Assessments came to acquire proper shape and structure following the heavy reference the WHO made to this discipline at the WHO European Ministerial Conference on Health Systems of June 2008. The following year, it found resonance again, when it was the theme of the World Health Day. The evaluation of Hospitals Management Performance Assessments Hospitals Management Performance Assessments started to evolve primarily to provide healthcare professionals with a tool to diagnose the quality of performance of the hospitals and other healthcare settings they work in. It was felt, over time and experience, that when strict appraisals were being made in many areas of healthcare, a set of parameters to assess the level of efficiency of hospitals would go a long way in ensuring the implementation of enhanced processes, leading to better patient outcomes. Areas of concentration for Hospitals Management Performance Assessments The core disciplines in which Hospitals Management Performance Assessments sought to bring about measurable and verifiable improvements were: The PATH approach As a result of discussions and deliberations the WHO held with many countries, primarily European, a path for charting out the course of Hospitals Management Performance Assessments was concretized in the form of what the WHO called the PATH - the Performance Assessment Tool for Quality Improvement in Hospitals. A brief understanding of PATH PATH