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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

Clinical Risk Management Lies at the Heart of Patient Safety : Clinical Risk Management is the process of identifying and mitigating risks in a healthcare setting. Risks are inherent in a clinical or healthcare practice, as they are in any other activity. But the field of healthcare has to be doubly wary of risk management because an adverse risk can cause irreparable loss if it leads to an event such as death. To a healthcare organization or practice, a bad event can harm the name beyond repair. How is risk identified? The first step to implementing a Clinical Risk Management is identifying the risks in the practice. This can be done in a number of ways: Why do healthcare providers need to implement a Clinical Risk Management strategy? Healthcare providers need to put in place a very sound Clinical Risk Management strategy for a number of reasons: Steps to putting a good Clinical Risk Management program in place A healthcare organization can put an effective Clinical Risk Management in place through a four-step process: Click Here for More Information: http://bit.ly/1OcHFXm

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

Hospital Management : The growth and development of hospitals has led to an altogether specialized discipline -hospital management. Hospital management is about coordinating the various functions of a hospital and ensuring optimal healthcare to patients and other stakeholders. Hospital Management has come a long way from being a supplementary duty that senior doctors handled with ease, to being a full-fledged specialization in itself. Hospital management is an altogether fully developed specialist profession whose managers are well qualified. Many institutions today offer courses on hospital management. The relationship of hospital management to the area of management rather than to the medical field can be understood from the fact that many hospital managers are from a purely management background, and have little knowledge of medical science. Many hospital management institutions offer an MBA. They also offer courses on specialized subunits of hospital management, such as hospital financial management, healthcare system management, hospital human resources management, etc. This is because hospitals have evolved over time. They are now ultra-specialist healthcare providers that use the latest technologies. A hospital could use anything from billing software to highly sophisticated technology used in its medical devices. A hospital management specialist needs to be not only aware of these uses; she also needs to be/have all these: A good administrator who handles staff; A deep knowledge of the information systems; A good grip on all the systems that need to be coordinated thoroughly if the hospital needs to function smoothly without any hassles; Dealing with facilities for patients. Hospital Management can thus be understood as being the facilitator between a healthcare setting and those who need these services. It is about ensuring that all the administrative elements of a healthcare setting function in unison to ensure provision of accountable healthcare.

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

What is HIPAA ? Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is a core requirement of the stakeholders involved in health information. HIPAA has prescribed standards with which to protect critical data relating to patients. Electronic Health Records (EHRs) are important documents that contain sensitive patient data, and are thus considered Protected Health Information (PHI). Since this data is accessible to a number of players involved in the field of healthcare; it extremely important to set regulatory guidelines aimed at ensuring that patient information remains protected. HIPAA compliance is essentially about staying in compliance with these guidelines. Measures needed to show compliance with HIPAA HIPAA requires a healthcare organization dealing with PHI to implement all of the following measures and comply with them: Physical measures Network measures, and Process security measures The role of HIPAA Privacy Rule and HIPAA Security Rule HIPAA has set out two important rules that pertain to compliance. These are the HIPAA Privacy Rule and the HIPAA Security Rule. While the Privacy Rule relates to how the medical information of a patient is saved, accessed and shared; the Security Rule is about how to implement national security safeguards for protecting electronic PHI, or ePHI. Who all need to be HIPAA compliant? Since the aim of HIPAA compliance is to ensure complete safety of patient data, it has requirements for every stakeholder in the EHR process. These stakeholders comprise: Covered Entities (CE): Anyone involved in the treatment, payment and operations in healthcare Business Associates (BA): Any person who has access to patient information and is involved in supporting treatment, payment or operations. These include third-party administrators and private sector vendors Those with whom BA's work, or those that are called subcontractors Hosting providers. These typically include healthcare software pro

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

Overview:  Emotionally difficult or painful conversations are very common in health care. Consequently, it is quite remarkable that health care training programs do not spend more time teaching future health professionals the kinds of emotional and relational skills that are often required in these kinds of patient-provider interactions. This presentation will discuss the architecture of the painful conversation by examining : Its effect on the professional's sense of self and especially his or her need to preserve self-esteem The critical role of feelings and emotions, and The nature and value of empathy. The latter half of the presentation will consist of various strategic and practical recommendations so that emotionally challenging conversations might be conducted artfully, especially with "difficult" or "impossible" patients. Areas Covered in the Session: By the end of this presentation, learners will be able to: Relate the painful conversation to their construction of their professional "self"; Explain how an ability to control one's feelings can influence the success or failure of an emotionally difficult conversation; List a number of empathic responses that are useful in conducting difficult conversations Who Will Benefit: Any health professional who has to communicate with others. Speaker Profile John D. Banja is a Professor in the Department of Rehabilitation Medicine and a medical ethicist at the Center for Ethics at Emory University. He also directs the Section on Ethics for the Atlanta Clinical and Translational Science Institute at Emory. Dr. Banja received a doctorate degree in philosophy from Fordham University in New York and has taught and lectured on topics in medical ethics throughout the United States. He has authored or coauthored over 200 publications and has delivered over 800 invited presentations at regional, national, and international conferences. He currently serves as the Editor of the American Journal

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

Clinical information: Clinical informatics is the new exciting kid on the block. With the right mix of aptitude and attitude, professionals can look forward to many opportunities and challenges in the field. An understanding of the coining of the term "clinical informatics" gives an idea of what it is. Clinical informatics is a combination of two words, "clinical" and "informatics". Together, these relate to the knowledge of how information technology works in the healthcare sector. It is very important for clinicians to understand the functioning of IT into its domain, because with the advent of IT; there has been a major need to integrate clinical practices with it. A clinician who understands the way IT impacts the workings on in her industry is a better equipped professional when it comes to handling IT-related issues in the clinical setting. A clinical informatics professional should have a clear idea of the following approaches to IT: Analysis Design Implementation Assessment of information and communication that enhance the quality of clinical informatics Single approach to multiple health areas: One important element that needs to be understood about clinical informatics is that given the scope and breadth of the area of clinical informatics; professionals from any discipline of health -be it pathology, pharmacy, dentistry, radiology, dermatology, etc. -apply the same principles of clinical informatics to optimize the use of IT in healthcare. This requires constant coordination and cooperation with professionals and practitioners of all these areas. Clinical informatics is thus an area which is interspersed with all these other specializations and can be used and applied in any of these areas. What should a clinical informatics professional ensure? The aim of clinical informatics is to use this discipline to coordinate with nearly all the areas of medicine to provide optimal outcomes in patient care that delivers and ens

In the business world as well as in the healthcare field growth is good. However, with growth comes a unique challenge; which may or may not be solved. Even though an evolving or growing medical facility services may not change, the internal processes related to claims submission, income cycle, billing and coding and revenue cycle management need a serious overhaul in order to stay efficient and sustainable as they scale up the operation.

Scientific medical writing involves writing detailed information about the basic medical sciences, drugs and latest technological innovation in the field of medicine for a range of audiences including medical specialists and health care professionals. This scientific information is written for publication in the medical journals, medical news, and regulatory documents. Contact us at : IND:+91 8754446690 US:+1-972-502-9262 UK:+44-1143520021 info@pepgra.com www.pepgra.com

Olive health & travel clinic ilford, London provide quality medical services in different fields like Private BCG london, Slimming jab, InterVax, Mobile phlebotomy, BCG NHS, Umrah vaccination, Ear irrigation, Hajj vaccination, BCG Injection. We also provide Travel vaccinations and antimalarials, Health Immunisations such as BCG, Shingles, HPV, Meningitis, Hepatitis B etc., Blood tests, Mobile phlebotomy (blood tests at home), Ear wax removal by irrigation method, Weight loss clinic (Saxenda), DNA/Paternity tests, and a range of health checks including STI testing.

Botulinum toxin is one of the most important substance to hit the field of facial rejuvenation.

Technology is changing just about every industry you can think of at a rapid rate. The medical and dental fields in particular are benefiting from advancements in technology significantly

Preimplantation Genetic Diagnosis is offering to help those that aren't sure if they can have children of their own or if they will suffer from certain medical issues in the future. Pregnancy and Fertility are two other reasons why this test can be offered. The procedure is done when the couple is preparing for conception by checking for any irregularities on an ultrasound. The genetic information from the unaffected parents and the affected eggs are compared to determine if a genetic problem exists with the egg of one of the partners. The growing number of fertility clinics around the globe coupled with the advancement in the field of genetic analysis is driving the growth of Preimplantation Genetic Diagnosis Market. The increasing need for early detection of chromosomal abnormalities in the fetus is another major factor fueling the growth of Preimplantation Genetic Diagnosis Market. The advent of next-generation sequencing (NGS) is also contributing to the market growth. Furthermore, the growing prevalence of gene-related disorders is further anticipated to augment the growth of Preimplantation Genetic Diagnosis Market. Additionally, growing awareness regarding genetic diagnosis of a specific gene mutation among healthcare workers is again anticipated to foster market growth. Also, increasing maternal age and growing incidence of aneuploidy is expected to uplift the market growth in the near future. Read more @ https://sachinbhombe.blogspot.com/2021/03/promising-fertility-rate-is-escalating.html

Contract manufacturing is a complex process involved in producing vaccine products. This type of production usually involves the manufacturing of vaccines in a single step. Contract manufacturers usually produce vaccines at their facilities; however, some contract manufacturers also service the field through the provision of workspace and by taking care of the closing storage and final disposition of finished products. Some contract manufacturers specialize in the manufacture of one or few vaccines. Others manufacture vaccines for a number of diseases. Technological developments in biomanufacturing and biotechnology are expected to drive growth of the global vaccine contract manufacturing market. Biotechnology has witnessed significant growth in the recent past in both developed and emerging economies. According to the India Brand Equity Foundation (IBEF), the Indian biotechnology industry was valued at US$ 63 billion in 2019 and is expected to reach US$ 102 billion by 2025, registering a CAGR of 10.9%. Besides, key biotechnology and pharmaceutical companies are focused on launching vaccines for protection against infectious diseases. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/vaccine-contract-manufacturing-market.html

The digital genome consists of a complete digital collection of DNA material that occurs within an organism or a cell. It's a simpler method to collect genetic data concerning hereditary disorders and is used extensively by geneticists for a closer look at potential genetic illnesses. It was first intended to be a tool of diagnosis but has evolved into a powerful research tool. The growing popularity of the human genome projects is a prime factor fueling the growth of the digital genome market. According to Forbes, by 2025, it's projected that 100 million genomes will be sequenced. Increasing funding for genomics is another major factor in augmenting market growth. Moreover, growing development in the field of biotechnology due to rising healthcare needs and increasing investment by the government is again driving the market growth. Additionally, the growing demand for personalized medicines coupled with the penetration of new players and start-ups across developing economies is also projected to foster market growth. Furthermore, the increasing prevalence of chronic disease is further projected to propel the growth of the digital genome market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/digital-genome-powerful-tool-for.html

Tonometers, also known as hand-pieces, are mechanical devices that measure eye pressure and the flow of fluid through the cornea, lens and retina. They play an important role in various fields of medicine such as ophthalmology, optometry, clinical measurements, and medical lasers. The most common use of a tonometer is for measuring intraocular pressure or the pressure of the fluid within the eye, which occurs during normal vision. Other uses include in the diagnosis and treatment of certain eye diseases, for obtaining an accurate reading of the pressure of tears during the night, and to prevent or detect possible internal bleeding or infections in the eye. Tonometry is a diagnostic test primarily used to detect glaucoma, one of the leading cause of irreversible blindness worldwide. Increasing incidence or prevalence of chronic eye diseases such as glaucoma is expected to propel the tonometers market growth. For instance, according to the Centers for Disease Control and Prevention, more than 3 million people in the United States have glaucoma. It is the second leading cause of blindness worldwide after cataract. Around 50% of people with glaucoma don't know they have the disease. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/increasing-prevalence-of-chronic-eye.html

The business of providing professional services and/or/ staff augmentation to Healthcare organizations has become a fast-paced field which enables healthcare institutions to quickly learn and apply their knowledge to a variety of problems. This field requires fighting challenges that are crucial for the success of healthcare providers' clinical and commercial future, and yet are severely difficult to solve. Likewise, the pressure to consistently maintain high-quality services and performance is also affected by the occasionally shifting goals of clients.