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Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

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.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

This division of Ind Swift aspires to help those who cannot afford costly branded medicines. It is further divided into Agile, Maxcare and Health Care divisions which include a vast array of over 500 products from various therapeutic segments namely Antibiotic, Anti-Infectives, Anti-Cold, Nutraceuticals, Anti-Convulsants, Analgesics, Anti-Diarrhoeal, Anti-Allergics, Anti-Inflammatory and Anti-Ulcer Drugs, Hypolipidaemic Drugs, Anti Malarial, Enzyme, Expectorants, Antipsychotics & Anti-Depressants.

At AmbitPCDPharma, a leading PCD Pharma Company providing PCD Franchise in Gujarat, distributor all over India. Our companies offer pharmaceutical products which are widely appreciated for its accurate composition, effectiveness and purity in India.

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

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.

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

Metastatic osteosarcoma is one form of the disease osteoarthritis. It has been found that this disease occurs due to a problem with the cells in the spinal cord that are responsible for the proper function of the joints. The disease generally affects the aging group and those individuals suffering from other medical conditions like diabetes etc. The pain caused due to metastatic osteosarcoma can be so severe that it leads to tremendous disability to the affected person. Increasing drug pipeline for malignant bones and soft tissue cancer is expected to drive growth of the global metastatic osteosarcoma treatment market. Key biopharmaceutical and pharmaceutical companies are focused on research and development activities to synthesize novel drug treatment for soft tissue and malignant bone cancer. For instance, in September 2020, Junshi Biosciences, a major biopharmaceutical company, received the U.S. Food and Drug Administration (FDA) Orphan Drug designation to Toripalimab for the treatment of soft tissue sarcoma. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/metastatic-osteosarcoma-treatment.html

Animal depression medications are usually only prescribed for depressed behavior in animals and are usually used as a stand-alone or second-line therapy, depending upon the degree of the condition. When treating depression in humans, it is most often treated with proper prescription medications, behavioral therapy, or counseling. The other classification of animal depression refers to biological causes like genetic defects and imbalances in the brain that result in depressive disorder in animals. As of now, only a few of these causes are known such as thyroid, immune system, endocrine, neurological disorders among others. However, it is believed that in the near future, a comprehensive list of the causes of depression in animals will be known. Increasing trend of pet adoption and growing pet humanization is expected to drive growth of the global animal depression medication market. Pet adoption is rapidly increasing in both developed and emerging economies. According to the American Society for the Prevention of Cruelty to Animals (ASPCA), around 6.5 million companion animals with 3.3 million dogs and 3.2 million cats enter the U.S. animal shelters nationwide every year. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/animal-depression-medication-market.html

Gastroesophageal Reflux Disease (GERD) is a chronic condition that is characterized by the regurgitation of stomach contents into the throat. GERD is also known as acid reflux disease and it occurs in people of all ages. In milder cases, GERD can be effectively treated with simple pharmacological therapies or by altering a patient's diet. In more severe cases, esophageal surgery might be necessary to remove the troublesome esophageal sphincter and/or improve a patient's general physical condition. GERD can develop when the lower esophageal valve relaxes or becomes weakened. The diagnosis of GERD and gastroesophageal reflux disease can be done by examining the medical history and symptoms. Although acid-reflux disease typically affects the upper body, some of its symptoms can extend down the esophageal tract, making GERD particularly troubling for people who sit or stand for long periods of time. This problem has given rise to a variety of different approaches to treatment, including invasive, surgical treatments, non-surgical treatments and more novel, non-invasive therapeutic approaches. The latest treatment option on the table involves using pharmaceuticals, such as selective serotonin reuptake inhibitors (SSRIs), to help reduce the effects of GERD. There are a number of advantages to this strategy. For starters, SSRIs are believed to have numerous side effects that tend to make them less attractive to certain groups of patients. Electrical stimulation (ESD) is another common form Gastroesophageal Reflux Disease (GERD) Treatment Devices. This technique involves the use of electrodes attached to the esophageal wall to generate a varying amount of electrical current. Antirheumatic drugs, which often cause symptoms similar to those of severe heart disease, are sometimes added to the mixture. A major disadvantage of using plicator devices with ESD is that the procedure can only be performed on an outpatient basis, requiring a patient to remain in the hospital for a fe

Anti-suicide drugs are the most commonly used pharmaceuticals that are prescribed for the treatment of schizophrenia and other mood disorders. The U.S. Food and Drug Administration (FDA) approved these medications in 1970. They are usually called antipsychotic medications. Although they are very helpful in controlling both the mania and depression, this medicine can prove to be very dangerous if taken in high doses even without an anesthetic. These medications are meant for temporary use only, therefore, care should be taken when using it so as not to cause any harmful side effects on the patient's health. Hence, people who have other illnesses should avoid using these medications. Antidepressants such as Clomipramine and Anafranil (Anafranil or Elavil) are some of the most commonly prescribed medications in the treatment for acute and chronic pain. They are effective in relieving the patient's discomfort and can also help him to come up with his life. However, there are reported cases where patients have experienced severe side effects such as confusion, hallucinations, drowsiness, dizziness, agitation, insomnia, and pupil contraction. Some patients may also experience headache, upset stomach, nausea, and diarrhea. Although these medications are very effective, they also have a number of side effects on the patient's health such as irregular heartbeat, blurred vision, and chest pain. Medications such as Carbamazepine, Lamotrigine, and Phenytoin are also known anti-suicide drugs. These medications act in a different way from other types of drugs. They work by altering the protein structures of neurons in the brain. Because of this, the patient's level of consciousness also differs from the patient who takes conventional antidepressant medications. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/02/emergence-of-covid-19-increases-cases.html

Antithrombin is an essential amino acid. It is the basic building block of all living organisms. Because it is the easiest to produce, it is an important component of cellular membranes and many other metabolic pathways. In addition to this role, it is also vital for maintaining cellular stability and the production of energy. As with all amino acids, there are six different positions that can be occupied by the molecule, namely: A, T, G, E, K, and S. This unique property of amino acid allows for the simultaneous occurrence of two distinct conformations, or isomers, of antithrombin. In addition, there is another interesting factor to consider. While there is only one inactivating factor, there are two forms of antithrombin, each having a dissimilar and highly dissimilar half-life in the bloodstream. In fact, the most widely used method to measure the efficacy of a pharmaceutical is the effect on coagulation factors. Specifically, this factor refers to the ability of the substance to stop platelets from clumping together and creating blood clots. While antithrombin deficiency can have some effects on this factor, it usually only shows itself in a positive pregnancy test for women with platelet-rich blood. It has also been found to reduce clotting times in patients with heparin-deficient conditions such as rheumatoid arthritis and dialysis. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/more-r-required-to-comprehend.html

Over-the-counter drugs (also known as non-prescription drugs) are drugs that one can buy without a prescription. These drugs are widely used to treat conditions that do not require direct consultation. Moreover, over-the-counter drugs are effective and safe when a consumer follows the instructions on the label or is provided by a doctor. The Food and Drug Administration in the United States considers when a specific drug is safe and effective enough to be sold over-the-counter. Over-the-counter drugs are widely used to treat symptoms of cold and flu worldwide. Several pharmaceutical manufacturers are focused on converting Rx (prescription drugs) to OTC (over-the-counter drugs) to meet the increasing demand. In the first half of 2019, Tachipirina was the best-selling non-prescription medication (over-the-counter drug) in Italian pharmacies. Rx to OTC switch is the transfer of proven prescription drugs to nonprescription. In February 2020, the FDA converted three prescription drugs to over-the-counter drugs, increasing access to the medicines. Moreover, many people worldwide prefer OTC drugs to treat minor illnesses before seeking professional care. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/over-counter-drugs-are-safe-and.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

Pharmaceutical drug prices are rising and contribute significantly to total health expenditure worldwide. Since 2014, prescription drug prices have increased by 33%. In 2020, global spending on prescription drugs is expected to be US$ 1.3 trillion. Increasing drug prices and consumer spending on prescription drugs are increasing the demand for the pharmacy benefit management system. The system is operated by third-party administrators who act as a link between drug manufacturers, insurance providers, and pharmacists. The system assists in reducing drug prices by negotiating with drug manufacturers and retail pharmacies. Those who are enrolled in various health schemes and those without insurance can get the benefit of the pharmacy benefit management system. The system provides medicines at a lower price than those available at retail pharmacies. To reduce rising health expenses, Japan planned to start reviewing drug prices every year instead of every two years. The move reflects growing resistance to rising drug prices worldwide. In Europe, different approaches have been implemented to regulate drug prices. In Germany, manufacturers can freely set the prices of newly developed drugs during their first year on the market. Benefit assessments are done during this year and then used in price negotiations between manufacturers and the country's representatives of statutory health insurers. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/pharmacy-benefit-management-is-integral.html

In addressing the sectors of biotechnology, healthcare, medical device and pharmaceuticals, our reports offer inclusive analysis, trends and competitors data. To stay ahead in the competition, we identify key concerns and provide solutions for companies in the healthcare sector to reach new heights.

Rise in prevalence and incidences of neurological disorders along with increased cost pressures of pharmaceutical drugs are anticipated to drive the electroceuticals market in the coming future. Moreover, rise in geriatric population and increase in investments for development of electroceuticals are expected to further boost the electroceuticals medicine market growth.