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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

Health Benefits Of Imunotop- H Giloy is good for boost immunity it protect the chronic Fever & also help in cancer. Shatavari help to relieves stress & anxiety. It also good for respiratory tract. Ashwagandha help to increases Strength & Muscle mass. It also reduces blood sugar level. Tulsi help to control headache, cough & cold. It also beneficial treating in Asthma. Black pepper is Good for diabetic. It help Oxygenates the body. Turmeric helps to boost immune system & detoxifies the Liver. Strengthen your immune system and improve your health naturally with Imunotop-h Ayurvedic Products that are made from natural herbs. It helps to fight and prevent you from various and influenza with no side effects.

Health Benefits Of Imunotop- H Giloy is good for boost immunity it protect the chronic Fever & also help in cancer. Shatavari help to relieves stress & anxiety. It also good for respiratory tract. Ashwagandha help to increases Strength & Muscle mass. It also reduces blood sugar level. Tulsi help to control headache, cough & cold. It also beneficial treating in Asthma. Black pepper is Good for diabetic. It help Oxygenates the body. Turmeric helps to boost immune system & detoxifies the Liver. Strengthen your immune system and improve your health naturally with Imunotop-h Ayurvedic Products that are made from natural herbs. It helps to fight and prevent you from various and influenza with no side effects.

Primary sclerosing cholangitis (PSC) is an uncommon chronic non-inflammatory disorder typically characterized by thickening, inflammation, and fibrosis of the bile tissues within the bile (septum) or the porcine bile duct (burgh's lobules). Both the apocrine and bile ducts are involved. The lining of the small intestine also becomes thickened. Patients generally have no symptoms. However, some symptoms may occur such as diarrhea, nausea, abdominal bloating, and vomiting. Other inflammatory diseases may co-occur with psoriasis. Primary sclerosing cholangitis is also called systemic sclerosis. It is one of the most common causes of cirrhosis of the liver in the U.S. In approximately one third of patients with PSC, no identifiable disease or infection is present. In approximately twenty-five percent of patients with this disorder, the disorder is diagnosed based on history and symptoms. In approximately ten percent of individuals with this disease, specific tests for an adequate diagnosis are not performed. Approximately two-thirds of individuals with PSC do not have a history of cancer or other systemic autoimmune diseases. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/effective-treatment-is-need-of-hour-in.html

Read the FAQ on Personal Alarms for the Elderly versus a monitored alarm system and get the answers for its annual cost, service and its alarm features. Choice of panic alarms is best cost effective alternative, that alert up to 5 or more contacts when the panic button is activated, are simple to install, have no on-going subscription costs and start at just €99 which includes a user friendly telephone.

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

In order to become a safe and effective medicine, a compound has to travel through a lengthy process of rigorous testing. Over the last few decades, the amount of time required to develop and test a novel drug has increased drastically. However, the introduction of social media and digital technology into drug development have the ability to significantly expedite this process. This webinar will explore the policies and principles of using social media through the evolution of developing a pharmaceutical drug from its initial stages to its introduction into the market. This includes analyzing the methods in which pharmaceutical companies utilize social media during the planning process, identifying the best candidate for the lead compound in a drug, conducting animal and human testing, recruiting candidates for clinical trials.

Overview: As the healthcare industry moves toward a value based reimbursement model rather than fee for service, it is crucial that the provider and ancillary staff understand how ineffective reporting can lead to dollars lost. We will review the 3 critical areas that require skilled management. Understand that patients are more educated about their healthcare and are increasingly responsible for more out of pocket costs. High dollar deductibles may result in self pay realities and bad debt increases. Learn areas that increase your chances for an audit. Are you ready for the challenge? Why should you Attend: Revenue is dependent upon proficiency in multiple areas. In today's environment, it is risky to maintain the status quo and increasingly important to obtain and maintain skilled business staff. The granularity of the ICD-10 code set requires understanding of the official coding conventions and guidelines, the ability to apply those guidelines, and the ability to recognize when reporting may lead to revenue delay, reduction or loss. Additionally, other factors affect your revenue stream. This includes patients with high deductible plans, collection of much more than a small co-pay, and staff understanding of regulations that govern telephone collection activity. Don't leave money on the table or invite an audit into your practice. Audits are often the result of weak billing and coding skills. This program will review several areas that will cost you money if poorly handled. Areas Covered in the Session: Required specificity in coding Documentation necessary for ICD-10 reporting Why coders must frequently query for clarification How ambiguous diagnosis reporting affects you r bottom line Internal collections versus outsourcing. What should you consider Staff effective in handling problem claims? Developing appeals? Who Will Benefit: Coders Billers Revenue cycle Physicians Mid-level providers Nurses Claims follow-up Managers Managers Speaker Profil

Overview: Final regulations for the new HIPAA Breach Notification Rule require much more than notifying individuals affected by a Breach of their Protected Health Information (PHI). Covered Entities and Business Associates first must follow and document a very specific process to determine if a Breach occurred. If no Breach occurred documentary proof must be kept for six years. If a Breach did occur timely notifications and other actions must be undertaken and documented. This webinar will explain: What Covered Entities and Business Associates must do to comply with the Breach Notification Rule What is and is not a Breach Three exceptions - when an acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is not a Breach How to perform a Breach Risk Assessment to determine if you can demonstrate a a low probability that the PHI was compromised Who must be notified in case of a Breach When notifications must be provided What information must be contained in each notification Other requirements in case of a Breach Investigate Mitigate harm to affected individuals Protect against further Breaches Document everything Planning and preparation for the worst - public relations and mitigation strategies to limit damage to the organization's reputation and financial well-being Why should you attend: Breaches and incidents that might be Breaches happen all the time! More than 173,000 separate breaches of Protected Health Information (PHI) affecting less than 500 individuals were reported to the U. S. Department of Health and Human Services (HHS) between September, 2009 and May 31, 2015 and in the same period HHS received approximately 1240 reports of PHI breaches that affected 500 or more individuals An acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is presumed to be a Breach unless it falls within an exception or the Covered Entity or Business Associate can demonstrate a low probability that the PHI was compromi

Overview: Participants will understand the importance of responding to the OCR pre-audit requests and how to respond. Our discussion will cover how to prepare for an anticipated OCR HIPAA privacy audit, by discussing how to conduct an internal self-assessment of your privacy program. We will discuss how to conduct the self-assessment, whether it be the need for policies, procedures or obtaining all of your business associates information. Why should you Attend: If you have received a request from the OCR to provide the name of your entities privacy official and additional criteria, you are already aware that you are on the OCR's radar and may be the focus of an audit. If you haven't received a request yet, anticipate receiving one soon. In addition to ensuring that your HIPAA program is audit ready, you also need to ensure that you know all of your business associates and have their information readily available to provide to the OCR. Your entity needs to be ready now, as the OCR will either conduct focused desk audits, on-site audits or both in effort to review documentation of evidence of your compliance with the HIPAA regulation. Areas Covered in the Session: Office of Civil Rights "OCR" requests for privacy official and additional information and timeline for response Internal assessment criteria of privacy program in anticipation of an OCR audit Conducting the assessment using the template based upon HIPAA regulations Discuss methods to address any found deficiencies 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

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analys

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

Clinical Risk Management Lies at the Heart of Patient Safety : Clinical Risk Management is the process of identifying and mitigating risks in a healthcare setting. Risks are inherent in a clinical or healthcare practice, as they are in any other activity. But the field of healthcare has to be doubly wary of risk management because an adverse risk can cause irreparable loss if it leads to an event such as death. To a healthcare organization or practice, a bad event can harm the name beyond repair. How is risk identified? The first step to implementing a Clinical Risk Management is identifying the risks in the practice. This can be done in a number of ways: Why do healthcare providers need to implement a Clinical Risk Management strategy? Healthcare providers need to put in place a very sound Clinical Risk Management strategy for a number of reasons: Steps to putting a good Clinical Risk Management program in place A healthcare organization can put an effective Clinical Risk Management in place through a four-step process: Click Here for More Information: http://bit.ly/1OcHFXm

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

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

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

Practical steps to compliance with HIPAA Computer Policy: That the HIPAA has a clear and stringent policy on computers is absolutely understandable, because computers constitute the very soul of HIPAA. Ensuring security of patient data is one of the core causes for which HIPAA was enacted; so, it is only natural that Computer Policy should be at the center of HIPAA compliance. A HIPAA Computer Policy rule came into effect in 2005. The nub of this enactment is to ensure that there are technical, physical and administrative security procedures that must be adhered with. These are meant for Covered Entities to ensure that the data they have of patients, namely electronic Protected Health Information (PHI) is safe and secure. Understand the reason for HIPAA Computer Policy Any implementation has to start with an understanding of the rationale for the action, right? The same goes for something as important and big as implementation of HIPAA compliance into systems. HIPAA Computer Policy is in place for a specific and critical reason ���protection of patient data, loss of which can lead to hefty penalties that can affect the business very adversely. So, installing the necessary protections is the first step to protecting vital data and with it, one's own business or practice, as well. Implement a sound access policy A strong access policy is at the heart of HIPAA Computer Policy. It is in the computer systems that all the data relating to the patient are stored. So, making sure who in the organization has access to these and how and when, is very important. Not only should access be restricted to only designated and permitted personnel in the organization; there should be a system by which tracking of access is easily determined. This is to find out who accessed which record, when, what action followed, what happened as a result of this access, and so on. Keep a record of all system components This is another step to ensuring compliance with HIPAA Computer Po

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analy