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Roger Steven

PQRS in 2016 - Keys for Success - 0 views

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    Overview: This webinar will cover the changes to the PQRS program in 2016 and will provide tips and strategies to help you select the best measures and reporting approach for your practice. Why should you Attend: Your future Medicare payments are at risk. Failing to report quality measures to CMS for Calendar Year 2016 will result in a reduction of up to 6% in your 2018 Medicare payments. The PQRS program carries a potential 2% penalty for each provider who does not report quality measures to CMS - physicians, mid-level providers, therapists, psychologists, social workers, even dieticians. In addition, if your practice has physicians and mid-levels, at least half the physicians must meet the PQRS requirements or the group will face an additional 2-4% penalty from the Value Based Modifier program. Areas Covered in the Session: Understand the difference between a reporting rate and a performance rate? Get access to useful tools to help you identify measures applicable to your specialty. Learn how to choose among the various reporting approaches - what are the pros and cons of each. Understand how CMS will evaluate your submission if you report less than 9 measures. Who Will Benefit: Practice Administrators All providers who bill to Medicare including Physicians (All specialties), Podiatrists, Physician Assistants, Nurse Practitioners, Psychologists, LCSW, Physical and Occupational Therapists, Speech/Language Pathologists, etc. Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice ad
wheelchairindia9

Functional Knee Support - 0 views

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    Tynor Functional Knee Support is specially designed to support knees which are injured or not working properly due to old age. It stabilizes knees during rotational and anteroposterior forces and cures the ligamentous knee injuries. It provides support to the knees by wrapping around them and thus facilitates their compression. It provides flexibility and easy movement of the knee. It is made of soft, durable fabric which can be stretched in four ways. It mimics the natural knee joint. It can bear the load and shock exerted on it from the external forces leaving the knee totally free from pressure. It contains no buckling or vaso constriction which might hinder comfort. It ensures the proper circulation of blood. It compresses the patellar region and hold it in right position and thus can be used for patellofemoral diseases. It is easy to maintain. Tynor Functional Knee Support Functional knee Support is an anterior opening device, which offers the advantage of controlled compression around the knee and a rigid lateral support and immobilization. It allows normal flexion and free movement of the knee joint. Anterio Open able Easy application Controlled compression. Perfect lateral splinting. Anatomical design. Tynor Functional Knee Support Features Bi axial heavy duty aluminum hinge Mimics the natural knee joint Ensures full weight bearing. Allows free flexion movement Four way stretchable fabric Controlled and comfortable compression No buckling No vaso constriction Enhanced comfort Open patella design Release patellar pressure Hold the patella in position Can be used for Patellofemoral diseases Wrap design with anterior closing Easy application and removal on swollen or asymmetric knees Easy application and removal for weak or geriatric patients. Allows customized compression Offers flexibility in sizing Ergonomic design Anti tourniquet effect - ensures no constriction to blood flow Better grip of the product to the bo
Roger Steven

HIPAA Compliance for a Practice Manager - 0 views

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    Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice or office manager needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.  Why should you Attend: The practice or office manager is the backbone of any healthcare office. Besides being responsible for many of the daily operations within an office, the practice manager is often tasked with managing the HIPAA compliance program. Knowing what is required is critically important.  Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and to make sure the practice has the proper policies and procedures in place. After completing this course, a practice or office manager will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations.  Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? The Role of the HIPAA Security and Privacy Official What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements?
sachin_cmi

High Potency Active Pharmaceutical Ingredients Market Is Fast-Acting Drug That Has Impr... - 0 views

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    High potency active pharmaceutical ingredients are molecules widely used in the production of hormonal drugs which are used for the treatment of breast cancer. It is also used in the central nervous system drugs, cardiovascular drugs, and musculoskeletal drugs. Moreover, recently they have been also gaining demand in the gynecology & cosmetics industry. These drugs are segmented into innovative and generic. The growing prevalence of cancer is predominantly fueling the growth of the high potency active pharmaceutical ingredients market. The increasing number of the pharmaceutical industry coupled with the growing investment in the research and development activities conducted by the pharmaceutical industry is again contributing to the market growth. Moreover, increasing use of high potency active pharmaceutical ingredients as antibody-drug conjugates as it is one of the most important and effective treatments for cancer is also projected to augment the market growth. It is also used to treat glaucoma which is further anticipated to foster the growth of the high potency active pharmaceutical ingredients market. From the geographical point of view, North America is expected to gain significant growth over the forecast period and this is attributed to the high prevalence of chronic disease in the region. Read more @ https://sachinbhombe.blogspot.com/2021/03/high-potency-active-pharmaceutical.html
sachin_cmi

Immunoassay instrument is gaining rapid adoption in the gene-based analysis especially ... - 0 views

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    Immunoassays, or DNA assays, are a method of DNA analysis. DNA is the basis of all biological material, including the DNA of living organisms, cells, and tissues. This method can be used to analyze, identify, and profile various biological samples. The analysis of DNA has developed greatly over the years, due to the ability to conduct DNA tests on living people. The use of immunoassays for gene-based analysis has grown tremendously. Primarily, immunoassay analysis is used to evaluate gene-based treatments in oncology, cardiovascular, orthopedics, infectious diseases, and clinical diagnostics. Currently, the primary uses of immunoassays are for the evaluation of gene-based therapies in oncology and cardiovascular clinical trials. The analysis and measurement of immune parameters by immunoassay instruments are known as response curve analysis (RCA). The first analysis of RCA was done by Ward and coworkers in 1980, using monoclonal antibodies to stimulate the lymphocytes Subsequent immunoassay measurement models and systems have been developed to extend the scope of research and to make immunoassay measurement more cost-effective. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/immunoassay-instrument-is-gaining-rapid.html
sachin_cmi

Increasing spending on R&D of new injectable drugs development escalating market growth... - 0 views

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    Disposable syringes are designed for one-time use and is discarded in order to prevent the spreading of infection. It can be defined as a sterile cylindrical medical instrument with a hollow needle at the end. This device act as a pump that easily draws drugs from vials and delivers these drugs to the body. A syringe is used to deliver injectable drugs in the body through an intravenous route. The growing use of injectable drugs across the healthcare sector is predominantly fueling the market growth of disposable syringes. The rise in global healthcare expenditure is another key factor propelling the market growth of disposable syringes. According to the World Health Organization, global spending on health was US$ 7.8 trillion in 2017 or about 10% of GDP and $1,080 per capita - up from US$ 7.6 trillion in 2016. Moreover, the growing demand for self-injection devices & long-acting formulations is again propelling the market growth. Increasing spending on R&D of new drugs development coupled with the growing demand for biologics will further favor the market growth of disposable syringes. Furthermore, growing concerns regarding needle stick injuries and accidental infections are also expected to bolster the market growth of disposable syringes. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-spending-on-r-of-new.html
sachin_cmi

Myelofibrosis Treatment Market Continues To Grow Owing To the Demand from Healthcare Se... - 0 views

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    Myelofibrosis Treatment includes medications and surgery. There are drugs and medicines which are used to cure myelofibrosis. Myelofibrosis is a muscle disease and various types of myelofibrosis treatment are available in the market to cure this condition. The muscle disease is caused due to myelodysplasia, a genetically determined trait that prevents the muscle from growing properly. Myelofibrosis is also known as spider veins, lying in regions close to the skin, like the armpits, groin, elbows, and knees. Myelofibrosis is the most common type of connective tissue disease. These medicines are generally used to control and stop the progress of the disease, after which, they suppress the activity of the immune system. Various types of steroids are used as medicines for myelofibrosis, to control the activity of the immune system and thereby stop the disease in its tracks. One of the most common drugs for myelofibrosis treatment is prednisone, which is generally used along with steroids. However, to treat spider veins and not myelofibrosis, a compound called Finasteride is used. The most important part of myelofibrosis treatment is a regular check-up, as early as 18 months of the disease a doctor can monitor the progress of the disease. Myelofibrosis treatment also includes physical therapy and other treatments to improve the symptoms of myelofibrosis. The main driving factor influencing the growth of the myelofibrosis treatment market is the increasing prevalence of myelofibrosis in emerging economies. For instance, according to Gleneagles Global Hospitals, the yearly incidence rate of myelofibrosis in India is 0.3 to 1.5 cases per 100,000 individuals. Most of the times these cases goes unnoticed since it is sometimes asymptomatic or less severe. Moreover, the market is estimated to grow owing to a large number of R&D investments, a large cluster of patients suffering from myelofibrosis, and better reimbursement policies. Read more @ https://coherentmarketinsights-bl
sachin_cmi

Increasing Adoption of Smartphones to Boost Demand for High Purity Alumina - 0 views

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    High purity alumina (HPA) is a high-purity form of aluminum oxide. It is majorly used in production of synthetic sapphire, LED lighting, lithium ion batteries, plasma display screen, photovoltaic cells, sodium lamps, phosphor, and optical lenses. It is homogeneous crystal in structure and is obtained by aluminum alkoxide hydrolysis process. There are three grades of alumina. One of these is called "high purity alumina", and it can be manufactured using different methods. In fact, the most commonly used alumina is the "super alumina". This is produced in a high pressure process using steam under a pressure of 2.7 bar. This type of alumina is extremely tough as it is made from pure alumina powder. Another type of alumina is "low-pressure alumina and "high-pressure alumina". This type is very strong and requires high pressure in order to get its properties. It is usually formed in a separate high pressure furnace. It is very strong and can withstand corrosion and rust. There are many benefits of alumina. It is very suitable for a wide range of applications. It can withstand corrosion and is very easy to clean and maintain. All these factors make alumina a perfect choice for a wide range of industrial uses. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/increasing-adoption-of-smartphones-to.html
sachin_cmi

High Prevalence of Cancer to Boost Demand for Contrast Media/Contrast Agent - 0 views

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    A contrast agent (also called a contrast medium) is an electrically charged material used in medical imaging to enhance the contrast of medical vessels or other tissues in the body. Contrast media/contrast agent either absorbs or changes ultrasound or electromagnetism, which is fundamentally different from radiopharms, which themselves emit electromagnetic radiation. This difference enables contrast agents to be applied to various body tissues with much higher strengths than their non-comp contrast counterparts. The most common contrast media/contrast agent used in medical imaging are CT contrast agents and MRI contrast agents. However, due to their non-magnetic nature, these medical imaging products are not able to be used on organ tissues, such as kidneys, hearts and lungs. Some manufacturers have now started manufacturing non-magnetic, biologically engineered CT and MRI contrast agents called mri-notherapy (mammography, radiofrequency ablation, and ultrasound contrast agents). High prevalence of cancer is expected to boost demand for contrast media. In the U.S., non-magnetic, biologically engineered CT and MRI contrast agents are now being used more frequently to treat patients with benign tumors of all types. Mri-notherapy is used for benign cancers of the breast (breast cancer), abdomen (belly fat), neck, head, joint (arthritis) and spine. Patients with melanoma, anemia, inoperable basilar artery disease, and multiple myeloma are also often treated with mri-notherapy. The therapy has a high success rate for benign tumors and very low incidence of mortality, espeacially in patients undergoing surgery. Moreover, recently, in November 2020, the U.S. FDA approved GE Healthcare's macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine), in pre-filled syringes. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/high-prevalence-of-cancer-to-boost.html
sachin_cmi

An Insight into how Innovative Rigid Knee Braces are Helping Patients with Osteoarthrit... - 0 views

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    Rigid Knee Braces are the most popularly used orthoses for the treatment of osteoarthritis pain. In fact, they are one of the major breakthroughs in the field of orthopedic therapy and orthopedic manufacturing. Rigid Knee Braces are very simple and easy to use. Unlike the traditional braces, these braces do not have any wires or screws that have to be threaded onto the bones. They can be worn at any time. The wires used here are made up of rubber. This helps to prevent the wires from creating discomfort to the bones of the knee. Furthermore, the wire used in these braces also prevents the fluid formation that is common in traditional braces. These braces help in exercising the stabilizers, tendons, and muscles that surround the joint. They also help in maintaining proper alignment of the bones. The tendons and muscles get stronger when they are properly exercised. Moreover, it also increases bone density. This makes the knee more resilient to shock and pain. Another important thing about Rigid Knee Braces is that it helps in reducing the pain felt in the knee. It is due to this reason that more people suffering from osteoarthritis are opting for these braces. The kind of osteoarthritis knee brace which can be used by a person depends on the severity of his or her problem. In general, there are two kinds of braces that are available. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/an-insight-into-how-innovative-rigid.html
Roger Steven

How to Ensure a Successful Health Care Systems Implementation - 0 views

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    Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje
wheelchairindia9

Best Wheelchair For Heavy Person - 0 views

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    People who are very large or heavy may have difficulty using regular chairs. In some cases, they are simply too wide to comfortably fit in an average-sized chair, and in other cases their weight may damage or break the chair entirely. This is not only humiliating to the person who sits in the chair, but could result in injury if the chair collapses. To avoid such an unfortunate occurrence as well as potential litigation, it is important to purchase heavy duty chairs that can accommodate larger family members, employees, and customers. Heavy duty wheelchairs can also be made for specific purposes. An off-road wheelchair, for example, is a heavy duty wheelchair designed for individuals who intend on spending a lot of time on rugged terrain. The most common type of heavy duty wheelchair is a bariatric wheelchair, which is designed to allow larger individuals adequate mobility. For this matter, heavy duty wheelchairs typically have larger seats than conventional wheelchairs. The frames of these wheelchairs can be made from several different reinforced metals, although a titanium wheelchair is often the most popular choice. The wheels themselves are made of thicker rubber than normal, preventing any possible failure due to the greater amount of weight supported. Most makes of heavy duty wheelchairs fold like regular wheelchairs, making storage relatively easy despite the wheelchair's increased size. For the user's convenience, a heavy duty wheelchair can either be manually-operated or motorized, each with its own pros and cons. A manual Heavy Duty Wheelchair gives full control of motion to the user, but the added weight from the reinforcements makes pushing or propelling the wheelchair much harder than normal. A motorized heavy duty wheelchair offers a solution to this dilemma, but is often more expensive and harder to maintain than a manual wheelchair. Some designs offer a combination of both, with a small motor assisting those pushing the wheelchair. The proper c
wheelchairindia9

Chest Binder - 0 views

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    Tynor Chest Binder Chest Binder is applied to the thoracic region to compress and bind the rib cage and provide splinting to the sternum while allowing sufficient flexibility for comfortable breathing. Anatomic chest pad. Controlled compression. Optimum chest splinting. Soft feel. Tynor Chest Binder Features 50 mm thick PUF pad hold and binds the fractured sternum without compromising on patient comfort. Strong elastic band gives good grip and helps in equidistribution of pressure. Reduces post operative pain and discomfiture. Facilitates phlegm expulsion after cardio thoracic surgery. Tynor Chest Binder Measurements Measure circumference around the chest.
lifelinelab

BREAST CANCER SCREENING - 0 views

  What is screening ? Screening is looking for cancer before a person has any symptoms. This can help find cancer at an early stage. When abnormal tissue or cancer is found early, it may b...

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started by lifelinelab on 07 Dec 18 no follow-up yet
pcdpharma19

Molnova Capsule Manufacturer, Supplier & Exporter in India - 0 views

Why Molnupiravir is Effective in fight against Covid-19 Molnupiravir is the world's first pill for the treatment of symptomatic Covid, and it was just approved for use. Many countries have given it...

MolnupiravirCapsules MolnupiraviravailableinIndia MolnupiravirmanufacturersinIndia

started by pcdpharma19 on 03 Mar 22 no follow-up yet
Roger Steven

HIPAA - How to Put a Compliance Program in Place - 0 views

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    Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to taken to mitigate risk. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements? What is a HIPAA data breach and what happens if it occurs? What are the penalties and fines for non-compliance and how to avoid them? Creating a Culture of Compliance Questions Who Will Benefit: Com
Roger Steven

How to Perform a HIPAA Risk Assessment - 0 views

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    Overview: The primary goal of this session is to demonstrate why the health care organization needs to perform a risk assessment and how to perform the risk assessment. This includes a description of the types of breaches of protected health information that have already occurred and the reasons those breaches happened. The presentation then provides that reasons that a risk assessment is required in a health care organization and who needs to perform the assessment. There are a number of approaches available both for purchase on the web and performed by professionals on site. This discussion helps the participant determine which approach is best for their health care organization and what portions of the assessment are most important to the organization. The topic addresses the key components of a risk assessment and how to perform the risk assessment. This includes how to define the specific risks, how to know, how to assess the likelihood and impact of the risk and the final determination on the level of severity of the risk for the organization. Finally, the session explains how to interpret the results of the risk assessment, how to use the results of the risk assessment for preparing the health care organization's policies and procedures and how to conduct the HIPAA training for its staff. Why should you attend: In addition to the negative publicity and potential fines, a breach of a patient's health information often leads to litigation which is also time consuming and costly. The way to avoid these situations is to perform a Risk Assessment to understand where the health care organization is risk of an unauthorized breach and provide a basis for becoming HIPAA compliant. There are three reasons why a Risk Assessment is necessary: First, both the HIPAA Privacy and Security Regulations require a Risk Assessment for the organization to be HIPAA compliant Second, as a result of the Risk Assessment the organization knows where it needs to address its effo
Roger Steven

Conducting a Privacy Investigation Without Doubt! - 0 views

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    Overview: Participants will learn how to conduct an investigation of allegations of patient privacy violations using a privacy "risk analysis" tool and steps that should be taken when a breach has been determined. Why should you Attend: You must conduct a prompt and thorough investigation of all allegations of privacy violations. A violation of a patient's privacy may result in monetary penalties, harm to your reputation and especially harm to a patient. You need to make certain your organization has the expertise to conduct a thorough privacy investigation, analyze the results and take all necessary action to mitigate and report violations when required. Areas Covered in the Session: Best practices for conducting a privacy investigation Use of the risk analysis tool Interpretation of your results Reporting requirements if necessary Recommendations of continued privacy monitoring Workforce training Who Will Benefit: Healthcare providers Compliance and Internal Audit professionals or office staff responsible for ensuring patient privacy Healthcare Administrators Business Associates and all HIPAA Covered Entities Speaker Profile : Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges from starting new compliance programs and making improvements to existing programs for physician practices to large health care organizations. Gail also has provided numerous lectures to healthcare providers, executives and professional colleagues. Gail Madison Brown will develop, implement, and oversee processes, systems, educational programs, and other activities necessary to support and grow clinical trials activities at the UT Health Science Center. The Chief Clinical Trails Officer (CCTO) provides overall strategic leadership in this area including planning, goal setting, and monitoring organ
Roger Steven

Medical Necessity: A Term in Search of Definition - 0 views

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    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
Roger Steven

Seminar on Marketing Products without Getting Hammered by FDA at SFO, CA - 0 views

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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
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