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FDA Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for retraining to prevent prescribing errors). The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012. Background Reporting of adverse events from the point of care is voluntary in the United States. The FDA receives some adverse event and medicati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine. VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Prescription
A prescription, often abbreviated or Rx, is a formal communication from a physician or other registered health-care professional to a pharmacist, authorizing them to dispense a specific prescription drug for a specific patient. Historically, it was a physician's instruction to an apothecary listing the materials to be compounded into a treatmentthe symbol ℞ (a capital letter R, crossed to indicate abbreviation) comes from the first word of a medieval prescription, la, Recipere (), that gave the list of the materials to be compounded. Format and definition For a communication to be accepted as a legal medical prescription, it needs to be filed by a qualified dentist, advanced practice nurse, physician or veterinarian, for whom the medication prescribed is within their scope of practice to prescribe. This is regardless of whether the prescription includes prescription drugs, controlled substances or over-the-counter treatments. Prescriptions may be entered into an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restriction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Epidemiological
Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and determinants of health and disease conditions in a defined population. It is a cornerstone of public health, and shapes policy decisions and evidence-based practice by identifying risk factors for disease and targets for preventive healthcare. Epidemiologists help with study design, collection, and statistical analysis of data, amend interpretation and dissemination of results (including peer review and occasional systematic review). Epidemiology has helped develop methodology used in clinical research, public health studies, and, to a lesser extent, basic research in the biological sciences. Major areas of epidemiological study include disease causation, transmission, outbreak investigation, disease surveillance, environmental epidemiology, forensic epidemiology, occupational epidemiology, screening, biomonitoring, and comparisons of treatment effects such as in clinical trials. E ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Biologics Evaluation And Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks (physician), Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologic medical product, biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and Cell therapy, cell, tissue, and Gene therapy, gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER). Scope * Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- Blood plasma, plasma derivatives, including intravenous immunoglobulin, immunoglobulins, Hy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Drug Evaluation And Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market. CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. The decisions on approval will often make or break a small company's stock pr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Dictionary For Regulatory Activities
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary. The first version of MedDRA was released in 1999 in English and Japanese. MedDRA is now translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. In MedDRA version 25.0, Swedish and Latvian translations were also added. In many countries/regions the use of MedD ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Professional
A health professional, healthcare professional, or healthcare worker (sometimes abbreviated HCW) is a provider of health care treatment and advice based on formal training and experience. The field includes those who work as a nurse, physician (such as family physician, internist, obstetrician, psychiatrist, radiologist, surgeon etc.), physician assistant, registered dietitian, veterinarian, veterinary technician, optometrist, pharmacist, pharmacy technician, medical assistant, physical therapist, occupational therapist, dentist, midwife, psychologist, or who perform services in allied health professions. Experts in public health and community health are also health professionals. Fields The healthcare workforce comprises a wide variety of professions and occupations who provide some type of healthcare service, including such direct care practitioners as physicians, nurse practitioners, physician assistants, nurses, respiratory therapists, dentists, pharmacists, s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Retraining
Retraining or refresher training is the process of learning a new or the same old skill or trade for the same group of personnel. Retraining is required to be provided on a regular basis to avoid personnel obsolescence due to technological changes and the individuals' memory capacity. This short-term instruction course shall serve to re-acquaint personnel with skills previously learnt (recall to retain the potentials) or to bring their knowledge or skills up-to-date (latest) so that skills stay sharp. This kind of training could be provided annually or more frequently as maybe required, based on the importance of consistency of the task of which the skill is involved. Examples of refreshers are cGMP, GDP, HSE trainings. Retraining (repetition of a training conducted earlier) shall also be conducted for an employee, when the employee is rated as ‘not qualified’ for a skill or knowledge, as determined based on the assessment of answers in the training questionnaire of the empl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Risk–benefit Ratio
A risk–benefit ratio (or benefit-risk ratio) is the ratio of the risk of an action to its potential benefits. Risk–benefit analysis (or benefit-risk analysis) is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to achieve certain benefits. For example, driving an automobile is a risk most people take daily, also since it is mitigated by the controlling factor of their perception of their individual ability to manage the risk-creating situation. When individuals are exposed to involuntary risk (a risk over which they have no control), they make risk aversion their primary goal. Under these circumstances, individuals require the probability of risk to be as much as one thousand times smaller than for the same situation under their perceived control (a notable example being the common bias in the perception of risk in flying v ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Error
A medical error is a preventable adverse effect of care (" iatrogenesis"), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment. Definitions The word ''error'' in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as human errors in healthcare. Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a healthcare provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%. The deaths that result from infections caught as a result of treatment providers ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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