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Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

Cancer is a disease caused when cells divide abnormally and uncontrollably and spread into surrounding tissues, which results in formation of a mass called tumor. Head and neck cancer refers to various malignant tumors that develop in or around the mouth, sinuses, nose, larynx, and throat. Moreover, head and neck cancer begin in squamous cells that line moist surfaces such as those inside the throat, nose, and mouth. Infection with human papillomavirus (HPV), excessive alcohol consumption, and chewing tobacco increases the risk of head and neck cancer. Other factors such as hereditary causes, Epstein barr virus infection, radiation exposure, occupational exposure, oral health, salted or preserved foods, excessive consumption of paan also increases the risk of head and neck cancer. Factors such as rise in government initiatives, surge in research and development activities, rise in health care infrastructure, and increase in the patient population are expected to propel the head and neck cancer market. Worldwide, head and neck cancer is the sixth-most common cancer, with around 630,000 people diagnosed every year, resulting in more than 350,000 deaths, according to the National Center for Biotechnology Information. Moreover, tens of millions of individuals are diagnosed with cancer each year and more than half of the patients eventually die from it. Moreover, cancer ranks the second most common cause of death in many countries, following cardiovascular diseases. Read more @ https://sachinbhombe.blogspot.com/2021/03/insights-on-salicylic-head-and-neck.html

Continuous peripheral nerve block catheter is a new technology of using catheters for intravenous insertion into the upper and lower extremities. As a result, this new technology is being used worldwide in various health care facilities for various procedures including cardiac catheterization, nerve blockage, and venous stasis ulceration. As such, there are many medical centers and hospitals that offer a wide variety of advantages offered by continuous peripheral nerve block catheters. As mentioned above, there are many benefits offered by a continuous peripheral nerve block catheter. These are mainly due to the wide variety of reasons as stated above that include: catheter introductions with less invasive techniques; better outcomes for patients; and fewer complications experienced by catheter users. The biggest advantage of using this technique compared to other procedures is its cost-effectiveness. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/an-insight-into-continuous-peripheral.html

Rigid Knee Braces are the most popularly used orthoses for the treatment of osteoarthritis pain. In fact, they are one of the major breakthroughs in the field of orthopedic therapy and orthopedic manufacturing. Rigid Knee Braces are very simple and easy to use. Unlike the traditional braces, these braces do not have any wires or screws that have to be threaded onto the bones. They can be worn at any time. The wires used here are made up of rubber. This helps to prevent the wires from creating discomfort to the bones of the knee. Furthermore, the wire used in these braces also prevents the fluid formation that is common in traditional braces. These braces help in exercising the stabilizers, tendons, and muscles that surround the joint. They also help in maintaining proper alignment of the bones. The tendons and muscles get stronger when they are properly exercised. Moreover, it also increases bone density. This makes the knee more resilient to shock and pain. Another important thing about Rigid Knee Braces is that it helps in reducing the pain felt in the knee. It is due to this reason that more people suffering from osteoarthritis are opting for these braces. The kind of osteoarthritis knee brace which can be used by a person depends on the severity of his or her problem. In general, there are two kinds of braces that are available. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/an-insight-into-how-innovative-rigid.html

Unlock the capability of efficient revenue cycle management in healthcare with professional insights on cardiology billing offerings and urology medical billing. Learn strategies to streamline procedures and enhance financial consequences. Fax:- 9179607960

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

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Overview: The idea of providing health care treatments and insurance coverage according to "medical necessity" determinations seems eminently reasonable. Its obvious ethical thrust is to discourage unnecessary, wasteful or fraudulent practices. As practically implemented, however, "medical necessity" regulations and determinations have proven remarkably controversial and elusive. First of all, the language connected with medical necessity is inherently vague. Language to the effect that a treatment is medically necessary if it is "likely to achieve a significant practical improvement," is "realistic," or "reasonable" will predictably cause disputes between payors and providers of care. Second, the persistence of these disputes calls into question whether evidence based practices have evolved to a point where they are all that reliable and useful. Third, medical necessity determinations incur problems as to who should ultimately make them: payors, health providers or the courts. Obviously, whoever controls the definition of medical necessity controls the flow of health care dollars. While ethical theory can offer important insights about our moral obligations, it remains unable to reliably translate its theoretical principles and rules bearing on harms, benefits and justice into informing medical necessity determinations. Thus, resolving disputes over medical necessity have taken a procedural approach that looks to the interpretation of contractual language in insurance policies, often at the bench of an administrative law judge. This presentation will advance a reasonable set of strategies whereby a convincing case can be made for certain care interventions qualifying as "reasonable and necessary." Why should you Attend: Despite their central importance as a locus for determining reimbursement, "medical necessity" regulations and determinations have proven remarkably controversial and vexing for at least the last 20 years. Yet, whoever controls the definition

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

"""Pancreatic Cancer Drug Pipeline Analysis""Pancreatic Cancer Drug Pipeline Analysis" by PNS Pharma gives comprehensive insight on the various drug profiles being developed for the treatment of Pancreatic Cancer. "

Ovarian Cancer Pipeline Analysis" by PNS Pharma gives comprehensive insight on the various drug profiles being developed for the treatment of Ovarian Cancer. Research report covers all the ongoing drug development in various phases.

Insightful article about differences between ACO & Patient - Centered Medical Home

Family practice EHR check list. Insightful White Paper on Check list of EHR which should help practitioners to make informed decisions when finalizing what EHR to choose

UK-based online therapy provider Ieso Digital Health has applied deep learning to provide new insights into which aspects of psychotherapy are the most effective.

Medical transcription services are health reports that are typed out from dictated medical reports by medical professionals, such as doctors, dentists, and physicians. These reports contain vital information regarding a patient's health and are crucial to their care. This service offers data accuracy and data-driven insights for making an easy decision regarding patient treatment and care. Medical transcription services can be classified into Discharge Summary (DS), History and Physical Report (H&P), Operative Note or Report (OP), Consultation Report (CONSULTS), and Pathology Report (PATH) & Radiology Report. Continuous advancement in the medical transcription services market is expected to drive the growth. For instance, in October 2020, ETranscription, a Canadian transcription company, launched its new website and platform to expand its high-quality transcription services. The company has offered a free trial and reduced rates to help hospital streamline their workflow. Moreover, updates support a seamless online transcription process while delivering secure, accurate, and cost-effective services. This service effectively reduces clinical documentation time and enables doctors to plan the patient's treatments. Increasing adoption of technologies such as digital health, telemedicine, and EHR is further anticipated to foster the growth of the medical transcription services market in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/medical-transcription-services-has.html

eClinical solutions are used to improve the clinical development process through data analysis and management. It offers clinical and operational data by providing data management software and customized data management services, including clinical reporting, electronic data capture, data management and standardization, and clinical data repository platform, with total transparency. eClinical solutions allow users to standardize, integrate, manage, and analyze all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Moreover, eClinical software help users to comply with budgeting, investigator management, patient management, government regulations, and adverse event reporting system among others. eClinical solutions integrate electronic health records, eTechnologies, electronic consent forms, clinical data management systems, and electronic data capture. Moreover, they are helping researchers in lengthy clinical research processes through proper management. eClinical solutions have gathered substantial market proposition among pharmaceutical and biopharmaceutical companies for streamlining their clinical trials and insights discovery across various phases from I to IV. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eclinical-solutions-help-reduce-human.html

Seasonal influenza is caused by viruses known as influenza A, B, C, and D. These names refer to the four types of viruses, and each has a different way of entering the human body. For example, an A virus can be transmitted through the air, while B is most often transmitted through secretions from the nose or mouth. C is the most commonly caught form of the disease but does not usually spread from person to person. Influenza A viruses are the only influenza viruses known to cause flu pandemics, i.e., global epidemics of flu disease. High prevalence of acute respiratory infections is expected to propel growth of the seasonal influenza vaccines market. For instance, the study, 'Viral and Bacterial Etiologies of Acute Respiratory Infections among Children under 5 Years in Senegal', published in the journal Microbiology Insights, in February 2018, found that adenovirus was the most prevalent (50%) among selected virus species, followed by influenza virus, rhinovirus, enterovirus, and respiratory syncytial virus. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the seasonal influenza vaccines market. For instance, globally, as of 4:25pm CET, 2 December 2020, there have been 63,360,234 confirmed cases of COVID-19, including 1,475,825 deaths, reported to the World Health Organization. Moreover, many people are getting flu shots along with COVID testing, which is also expected to aid in growth of the market. For instance, in December 2020, Tarrant County, TX, U.S., partnered with pharmacies at Kroger and Tom Thumb to help provide free flu vaccines for uninsured residents. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/emergence-of-covid-19-to-augment-growth.html

The global metagenomics market was valued at $176 million in 2017 and is expected to reach $523 million by 2024 at a CAGR of 16.8% from 2018 to 2024. Metagenomics comprises studies that use sequencing technologies and bioinformatics tools to obtain useful insights on the diversities in the microbial community and interaction of the microbes in a community.

Scientists while performing various researches to discover new treatments for various diseases generate and analyse vast amount of information related to drugs and indications. Discovery informatics utilizes various methods and approaches to in creating such knowledge base and help analyse such huge database to derive valuable insights used in drug discovery process.