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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

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

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: 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: In this webinar, Hope will present the lessons she's learned over her career as a grant writer and editor in medical research. By identifying simple solutions to common problems, participants will learn tools to improve their ability create competitive grant applications and increase their academic and research productivity. To write compelling grant applications, this webinar will cover: How your choice of words will help you stay within page limits without compromising the science How to minimize abbreviations to improve readability and respect reviewer time constraints How to use Microsoft Word efficiently to improve page layout and readability How to manage references by enlisting online databases and reference management software How and when to stop developing the content to meet both grantor and institutional deadlines Why should you Attend: Many Grant Writing workshops do not teach writing per se. Though useful for beginning grant writers, most focus on understanding the application process and the various sections of a grant. For participants wanting to learn to actually write a grant, they are often left to figure out the technique for themselves. In addition, funding opportunity applications (FOAs) have changed quite rapidly in the past few years and require more focused writing in fewer pages. Competition has increased as budgets have shrunk, and knowing how to make the most out of both the time and the length of a grant project can prove challenging and extremely stressful. This webinar is for both new and experienced grant writers, either scientists and principal investigators or writers and other support staff. By using common resources (MS Word, EndNote, PubMed), the webinar content is designed to help grant-writing teams increase their efficiency in the writing process and also meet the requirements of the FOAs. Plus, plain language and good writing practices taught in this webinar will ensure straight-forward, content-rich, and well

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

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

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Cancer Research UK has announced a £56m research network to transform the UK into a global hub for radiotherapy study. By leveraging the use of the latest techniques, such as FLASH radiotherapy and artificial intelligence (AI), the network aims to accelerate the development of advanced radiotherapy.

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

A 3D cell culture is basically an artificial environment where biological cells are allowed to grow or interact naturally in all three dimensions, similar to how they do in vivo. Unlike 2D cultures, a 3D culture allows living cells in vitro to adopt all possible growth directions, much like how they would in the real world. This is ideal for treating diseases that involve multiple organ systems. In medicine, this is known as organo-evolution. Here are some advantages of 3D cell cultures: Unlike before, it is now possible to culture different kinds of cells such as blood, sperm, and stem cells in vitro. This was made possible by the introduction of new equipment called the culture chamber, which is used to manipulate cells in culture. Before, only two types of cells were possible to culture, monoclonal (which are typically the type found in bodily tissue) and plating (which are typically found in muscle and blood cells). In addition, the 3D cell culture can be controlled, making it more useful. For instance, researchers can use different types of media on different cells at the same time; this can help them investigate cell culture in more detail. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/3d-cell-culture-allow-researchers-to.html

Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity.

The global veterinary CRO market was valued at $577.20 million in 2020 and is projected to reach $1,175.72 million by 2030 registering a CAGR of 7.7% from 2021 to 2030. Contract research organizations (CROs) are companies that help assist in research & development and/or other services related to newer products for sponsor companies.

Proteomics - Technologies, Markets and Companies"describes and evaluates the proteomic technologies that will play an important role in drug discovery, molecular diagnostics and practice of medicine in the post-genomic era - the first decade of the 21st century. http://www.bharatbook.com/market-research-reports/healthcare-market-research-report/proteomics-technologies-markets-and-companies.html

The Physician Payment Sunshine Act: The Physician Payment Sunshine Act, also called Physician Payments Act, is a piece of legislation passed by the American Congress in 2010. It came to be enacted along with the Affordable Care Act, or Obamacare. The purpose of this legislation is to ensure transparency in the financial relationships that exist between the pharmaceutical industry, teaching hospitals, and physicians. What the Sunshine Act requires is this: Manufacturers of drugs and medical devices, and organizations that purchase in groups (Group Purchasing Organizations or PGO's) have to report payments or their equivalent that they make to physicians and teaching hospitals. Items that are considered equivalent to money payments, transfers of which have to be reported are clearly mentioned. These include the following: Meals Honoraria or grants Gifts Entertainment Speaking fees Writing services, such as research papers or manuscripts Travel reimbursements Purchase of items such as teaching materials and journals, which are paid either directly to physicians or teaching hospitals, supplied either directly or through a third party Funding for research Another core reporting requirement: Another requirement of the Sunshine Act is that when manufacturers of drugs and medical devices and group purchasing organizations have physicians who have a stake in some or another form in their organizations; this has to be reported to the Centers for Medicare and Medicaid Services (CMS). These reporting requirements apply to all kinds of physicians, who are either specialists or are general practitioners. However, the following are excluded from reporting by the Sunshine Act: Nurses Support and office staff Residents Medical students Physicians assistance Advance practice nurses Physicians need not report: The Sunshine Act requires information about these payments and transfers to be made by the paying medical device and drug companies, and not by physicians.

pepgra is dedicated to providing the highest quality scientific editing service available in research and academia. Our specialized English- and non-native English-speaking editors help you in preparing documents for publication in top academic journals. We have a team of 200+ professional, experienced editors in Science, Technology, and Management, who edited research documents in more than 170 specializations. While editing your documents, we ensure the critical documents are polished and ready for publication. Our scientific editors can proofread and format your scientific documents, create tables and figures, and embed images and make your presentation an appealing one. pepgra provides unparalleled flexibility with unlimited editing service levels and services in both UK and US English. Journal ready formatting is applicable based on the level of editing chosen, and a journal pre-check is included based on the request at all of our service levels Contact us at : UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690 info@pepgra.com www.pepgra.com

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

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