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The human microbiome is comprised of archaea, eukaryotes, bacteria, and viruses that reside within anatomical sites of the human body including skin, placenta, uterus, mammary glands, lung, saliva, oral mucus, etc. There have been various attempts at understanding the mechanism of this microbiome. The U.S. National Institutes of Health (NIH) launched 'The Human Microbiome Project' to enhance the understanding of microbial flora that is involved in human health and disease. The goals of the project were to reveal the diversity of the microbial community in healthy people, to assess the impact of the environment on the microbiomes of individuals, and to identify new applications for these microbes. The microorganisms in human bodies are an important part of a balanced natural system. This project is a collection of over 100 human microbiomes that was obtained from healthy individuals of the U.S. This reference panel was then compared with the microbiomes from the same individuals' stool samples. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/human-microbiome-project-is-gaining.html

For so many years, medical science professionals have been focused on developing cost-effective and efficient methods of treatment and diagnosis. Genomics refers to the study of genetics, which covers how a single gene affects a particular disease to the entire genome. It is also an interdisciplinary field of research focusing on the genetic architecture, function, sequencing, mapping, and editing of human genomes. A human genome consists of all the genetic information that makes up a particular individual, which has resulted in many important advances in medicine and in helping scientists understand the genetic makeup of the human body and the environment in which the cells grow and multiply. One of the most significant advances in the field was the discovery of the Human Genome Diversity Project (GHD), which revealed that all people have varying degrees of genetic variation within their genomes. Moreover, the Human Genome Project also resulted in the first genome maps and maps that can help researchers determine where specific mutations have been inherited. Read More @ https://www.blogger.com/blog/post/edit/preview/9197580861156902959/8311782016390208480

In humans, a deficiency of growth hormone is caused when the pituitary gland does not include adequate concentration of human growth hormone. This deficiency is treated by injecting human growth hormone with a subcutaneous injection. Various genetic disorders such as Prader-Willi syndrome and Turner syndrome can also cause growth hormone deficiency, resulting in delayed puberty and shorter height than averages.

Cognitive computing materials refer to computer-based technologies that use machine learning algorithms to emulate how the human brain operates. Eventually, this emerging technology will facilitate the production of artificially intelligent computer systems that are capable of resolving issues without the aid of human assistance. One very exciting use for these artificially intelligent software programs is the development of new businesses. Cognitive computing is particularly useful for assisting humans in the business domain such as those in finance, supply chain management, customer service, and product development. The key challenge in implementing artificial intelligence or cognitive computing technologies is to create a system that can work without direct interaction from humans. For instance, the data analysis systems used by banks are able to operate even without the presence of bank employees. The banks have now leveraged the power of artificial intelligence to make their analytical work much faster and more efficient. In the near future, self-driving cars with artificially intelligent drivers will be seen in the streets of our cities, allowing individuals to commute safely between points. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/cognitive-computing-materials-are-being.html

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links 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 Clinical Research Coordinators Principal Investigators/Physicians 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 fu

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

Natural Killer cells are described as high, globular lymphocytes that are able to generate natural cytotoxic antibodies against cancer cells in a human body. These cells have the ability to kill even the living cells in a human body and apparently, the natural killer cells can also destroy cancer cells in a patient's body. Natural killer cells can also destroy leukemia, cancer, and lymphomas in humans. And since then, this technology has been improved to more precise results and can be applied in various experimental treatments. Increasing demand for natural killer cells for the treatment of cancer is a key factor driving the growth of the Natural Killer Cells market. According to the World Health Organization, Cancer is among the leading causes of death worldwide. In 2018, there were 18.1 million new cases and 9.5 million cancer-related deaths worldwide. By 2040, the number of new cancer cases per year is expected to rise to 29.5 million and the number of cancer-related deaths to 16.4 million. Moreover, it is also used in the treatment of other infections and liver diseases are again anticipated to augment the growth of the Natural Killer Cells market. The rise in the R&D for the development of specific antibodies for improving the activity of NK cells is further projected to accelerate the growth of the market over the forecast timeframe. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-prevalence-of-cancer-around-globe.html

"Global Human Vaccine Industry 2013-2018: Trend, Profit, and Forecast Analysis"comprises primarily human vaccine production. The annual revenue of this industry is forecast to reach an estimated $41.85 billion by 2018, with good growth over the next five years.

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Human embryonic stem cells were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman, and independently by Gail R. Martin. In 1995, the first successful culturing of embryonic stem cells from non-human primates occurred at the University of Wisconsin-Madison.

Decline birth rate worldwide has led to the increasing adoption of various human reproductive technologies. For instance, according to the World Bank, Japan's birth rate, crude (per 1,000 people) decreased from 8.413 in 2005 to 7.4 in 2018. On the other hand, the increasing population has also led to the approval and launch of contraception products. In May 2020, Evofem Biosciences, Inc. received the U.S. Food and Drug Administration (FDA) approval for Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel used to prevent pregnancy in females of reproductive potential for use as an on-demand method of contraception. As the use of human reproductive technologies advances, there is increasing concern about ethical issues surrounding these medical interventions. While the use of fertility medication has been approved by the FDA, there are still questions about how to regulate it because of the fact that it is not a prescription and because of the inherent risks associated with using the technology. The first thing that we need to recognize is that the technology of artificial insemination has been around for decades. The only difference today is that we now have the ability to use technology to assist in the process of getting pregnant. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/declining-birth-rate-and-increasing.html

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

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: 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: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analys

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analy

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

The Human Microbiome refers to the group of microorganisms that reside on skin layers, and in saliva, conjunctiva, oral mucosa and the gastrointestinal tract (GIT). It includes bacteria, archaea and fungi. Despite being parasites, these microorganisms perform tasks which are beneficial for the human host in maintaining health.

Tissue and Organ Transplantation is a complex medical procedure where an organ is transplanted from one human body to another human body, to replace a missing or damaged organ. The patient who has had their organ transplantation may not be aware of what happens during the procedure. The organ transplantation can either take place inside the patient's body, or the patient's body and organs are taken to a different location for transplantation. The transplant can also take place outside the patient's body; however, this is less common. There are two basic ways that Tissue and Organ Transplantation takes place. The first involves a person's own body being used as a donor organ, and this can be done when a person is born, during childhood, or through the age of death. The other method of organ transplantation involves a donor organ coming from another person, usually an older person who is capable of receiving a transplant. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/tissue-and-organ-transplantation-has.html