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

Basics of the Anti-Kickback Statute : The Anti-Kickback Statute is aimed at curbing abuse and fraud in the Medicare and Medicaid systems by professionals who offer services and benefit in direct or indirect ways. In order to protect Medicare and Medicaid patients, as well as federal health care programs from abuse and fraud; the Anti-Kickback Statute was enacted. The core act that the Anti-Kickback Statute considered as fraud and abuse is the unlawful acceptance or diversion of money into influencing medical decision-making. The Anti-Kickback Statute is very clear on this. It states that anyone in the healthcare industry, who consciously and deliberately accepts a fee or remuneration of any kind or offers the same with the intention of manipulating the course of a medical decision-making, is liable to punishment. What acts attract penalties? Acts of various kinds attract penalties under the Anti-Kickback Statute. Some of these include: Carrying out advertising or marketing activities for promoting the brand of health care providers Participating in affiliate programs or pay per click commissions Working out promotion agreements with multiple companies Taking part in sponsorships Working out strategic alliances with healthcare providers Licensing content or technology Selling a healthcare provider's brands of products or services Taking a cut in the advertising revenue The nature of penalties under the Anti-Kickback Statute The Anti-Kickback Statute states major penalties for acts it prohibits. The Anti-Kickback Statute prescribes these major penalties: Up to five years in prison This has the potential to attract additional monetary fines of up to $25,000 Administrative civil money penalties that can go up to $50,000 In addition, the Office of Inspector General (OIG) could initiate administrative proceedings and take steps aimed at prohibiting anyone convicted of an Anti-Kickback violation from participating in State and federal programs. The OIG could also impose

The Center for Medicare and Medicaid Services (CMS) proposed a new rule that will update the payment policies and rates. The update will specifically cater to Hospital Outpatient and Ambulatory Surgical Centers (ASC). The rules will set forth a motion to promote efficient service and promote higher quality service for all the Medicare beneficiaries.

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

MIPS has elevated the way Medicare part B providers get compensated. Each category, including Promoting Interoperability, has specific measures and guidelines that need to be fulfilled for MIPS 2021 reporting.

Tynor Walker Boot Tynor Walker Boot is designed for rehabilitation after injury, fracture , sprains or surgery of foot, ankle or lower leg. The boots provide support to the ankle and leg without inhibiting mobility. They can be a substitute for cast or can be used in case of early cast removal. With a wider rocker bottom, these boots promote a natural gait, reduced plantar pressure, enhanced stability and comfort to the lower leg. Light weight. Sturdy Support. Enhanced mobility. Maintains normal gait. Tynor Walker Boot Features Moulded foot Improves gait Rocker sole-helps in easy ambulation Offers stabilization of the foot ankle and the lower leg Comfortable positioning and protection of the foot Aluminum lateral bars Rigid support-Improved immobilization of the ankle and the lower leg Malleable, shape can be customized for better fitting and support Foam liner and Pad set Ensure extreme comfort Ensure perfect fit of the leg in the orthosis. Hook Loop system Easy removal and application of the product Allows wound inspection Allows personal hygiene Perfect fitting of the product Improved stabilization.

The Department of Industrial Policy and Promotion (DIPP) has released a statistic affirming Foreign Direct Investment in the region of pharmaceuticals and drugs. The value of investments will be around US $ 8.81 billion that comes to about Rs 48,828.3 crore in Indian currency. It is predicted that, the biotechnology industry will surpass 11.6 billion dollars by the year 2017

Bariatric Wheelchair is often referred to as a Heavy Duty Wheelchair or Extra Wide Wheelchair with extra weight capacity, reinforced cross braces, and various other design features to ensure that there is reliable durability to handle the extra support. Whether it is additional weight capacity requirements, or simply a wider seat pan or seat width, a wide range of chairs available in the Bariatric category, there are several models and seat widths to choose from in the Reclining Wheelchair or otherwise known as High Back Wheelchair Category. Bariatric Wheelchair is a supportive and comfortable device that provides users with a safe way to experience more independence. The rugged frame made from high-strength aluminum is lightweight yet handles up to maximum weigh so that bariatric patients can have greatly expanded mobility. A wide seat, wider-than-usual casters and tires and double crossbraces provide a reliable and stable foundation that keeps users safe and satisfied. The nylon upholstery is highly breathable, minimizing moisture even during extended periods of use. The Bariatric Wheelchair flip-back, padded armrests and the anti-slip footplates are both adjustable, enabling to get a precisely customized fit. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Commodes are used with a plastic commode pan that must be emptied at regular intervals. The commode pan is removed either by lifting it out from the top or by sliding it out from underneath. These commodes are only designed to transport the user a short distance, e.g across a bathroom, and are not an alternative to a wheelchair. People difficulty standing from chairs, toilets etc then it is important that the commode use has armrests and has a suitable seat height. Ideally, users shou

GM LITE POWER WHEELCHAIR GM Lite Brushless Power Wheelchair with Batteries is a revolutionary light weight power wheelchair using brushless motor. It is the most economic power wheelchair without sacrificing safety & durability. The wheelchair promotes pressure redistribution, reduces downward sliding and helps maintain good posture. Specifications: 10 times longer life Lightest - 23 kg 5 year long life, safe LiFePO4 battery (10ah) High efficiency brushless hub motor 5 seconds folding and unfolding Easy to carry Load : 120 kg Speed : 8km/hr Range: 15 km Slope : 12% 24V180W brushless 8-inch gear hub motor

Don't miss out on this great promotion! Enjoy up to 30% off every eyeglasses & Eyewear product in St. Louis, IL area. See office for details. This offer ends March 31, 2015. For more details call us 314-423-3874 & Email: ovstaff@overlandoptical.com

Overview: If you've ever felt the frustration of unpredictable results in splint therapy, you're not alone. Join us for this eye-opening course as Dr. Jesek zeroes in on the dentist's role in diagnosis and treatment of TMJ conditions as they relate to occlusion. Why should you Attend: Dr. Jesek is the founder of Jesek Seminars for Success: Promoting and Teaching Excellence in Dentistry (an approved AGD Pace provider.). He has presented at national meetings for the Academy of General Dentistry, the American Equilibration Society, the American Dental Association, the American Academy of Pain Management and Chicago Dental Society Midwinter Meeting. Seminar attendees appreciate his passionate, easy to understand approach and his teaching style, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: TMJ anatomy and muscles of mastication function. How to use bimanual guidance to determine TM joint health. How to palpate muscles of mastication. Differential diagnosis of TMD and occlusomuscle disorders. Temporomandibular joint rehabilitation. How to know when occlusal treatment will work predictably. How to identify and treat trigger points and muscle pain. How occlusal appliances make restorative dentistry easier. What imaging is needed: panorex, transcranial, tomogram, CT or MRI, and why. How to use emergency appliances to eliminate acute occlusomuscle pain. When you can just equilibrate the teeth and not use an occlusal appliance. How to stop the need of grinding on your crowns at delivery. Who Will Benefit: Dentist and Hygienists Speaker Profile Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1

Counselling in Ilford helps the client to identify what the issues are and promote potential solutions to the problem which is causing the client to seek for help.

Building your immunity doesn't have to be complicated. Most people dread the process because they think they have to follow an awfully difficult diet plan or gulp down bitter decoctions. The good news is you don't have to jump through any of these hoops to increase your immunity and overall wellness. Kerala Ayurveda provides organic jam that is 100% natural, sweet, and comes in convenient packaging. Scoop it out of the jar and spread it over the bread, or eat it as it is. The recommended dosage is 1-2 teaspoons a day, preferably alongside your breakfast. If unsure, consult your Ayurvedic practitioner for the right dosage. This organic jam is made with a special blend of antioxidant-rich ingredients like Amalaki fruit, clove, cinnamon bark, and various other herbs that help build immunity and promote overall wellness. It also contains just the right amount of ghee, which acts as a bio-enhancer for maximum absorption. Apart from improving immunity, this sweet organic jam also helps pacify vitiated doshas, enhances blood circulation, aids in digestion, and helps stay healthy and age gracefully. Visit the official website of Kerala Ayurveda to place your order now.

Workplace wellness programs are a harmonized set of health promotion strategies that are executed at worksites and include programs, policies, and certain benefits to the community designed to encourage health and safety of employees.

Aromatherapy is a holistic healing treatment that uses natural plant extracts to promote health and well-being. Sometimes it's called essential oil therapy. Aromatherapy uses aromatic essential oils medicinally to improve the health of the body, mind, and spirit. It enhances both physical and emotional health. Aromatherapy is thought of as both an art and a science. Recently, aromatherapy has gained more recognition in the fields of science and medicine.

Tynor Anklet Comfeel Anklet comfeel is a next generation product, to provide mild compression, warmth and support to the ankle joint. It is used to allay pain and inflammation, generally associated with old age, arthritis or injury. Knitted on 3 dimensional computer controlled circular looms, it conforms to the complex anatomy of the ankle with exactness. Closed heel Anatomic shape Four way stretch Uniform compression Simple pull on application. Tynor Anklet Comfeel Features Anatomically shaped and reduced compression on patella Better compression and grip Easy knee movement Perfect conformance to the complex anatomy of the ankle Improved comfort Bi-layered, cotton on the inside , a dermophillic interphase Enhanced comfort Better sweat absorption Better patient compliance. Bilayered, nylon on the outside Ensures long life Excellent aesthetics Color fastness. Four-way stretchable fabric Effective compression Enhanced comfort. Two layered with interwoven air space Retains body heat effectively. Speeds up healing Allays pain

GM LITE POWER WHEELCHAIR GM Lite Brushless Power Wheelchair with Batteries is a revolutionary light weight power wheelchair using brushless motor. It is the most economic power wheelchair without sacrificing safety & durability. The wheelchair promotes pressure redistribution, reduces downward sliding and helps maintain good posture. Specifications: 10 times longer life Lightest - 23 kg 5 year long life, safe LiFePO4 battery (10ah) High efficiency brushless hub motor 5 seconds folding and unfolding Easy to carry Load : 120 kg Speed : 8km/hr Range: 15 km Slope : 12% 24V180W brushless 8-inch gear hub motor

All pediatric wheelchair can be configured with many accessories to meet specific needs. Comfortable, sporty, and reliable.Aesthetically, devices designed for kids are often sleek and colorful, and functionally, they are typically lightweight and adjustable. As any parent knows, young people don't stay the same size for long and since a wheelchair is a major purchase don't want a simple growth spurt to render it useless. That's why kids wheelchair category offers models that feature seat width and depth adjustability, elevating legrests, and other versatile features. Cerebral Palsy Wheelchair: Cerebral Palsy Wheelchair Description The model designed for cerebral palsy child only. Ultra light weight aluminium alloy frame Seat Width 38 cms (15") Net Weight: 18.5 kgs Epoxy powder coated frame Detachable arm rest & foot rest provided Elevated and swinging foot rest Elevated foot rest provided to elevate leg angle Height adjustable and detachable head rest Hydraulic reclining high back for a comfortable posture Hydraulic adjustable seat angle Detachable back and seat pad Extra cushion upholstery provided to under arm, head & calg Foldable Lever and paddle brakes provided Safety belt provided Maintenance free rear solid wheels Cloth look like water proof upholstery Anti wheels for better safety and stability Extra cushion upholstery provided to under arm, head & leg Folding action Lever and paddle brakes provided Safety belt provided Maintenance free rear solid wheels Cerebral Palsy Wheelchair Recline system: Recline system provides kids with the most comfortable resting environment. It also allows stretching abdominal muscle that reduces the stress and discomfort developed after long sitting on the wheelchair. some characteristics of wheelchair pediatric: Lack of muscle coordination when performing voluntary movements (ataxia). Stiff muscles and exaggerated reflexes (spasticity). Asymmetrical walking gait with one foot or