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Biopharmaceuticals contract manufacturing refers to pharmaceutical companies outsourcing the development and manufacturing of drugs. It is driven by the use of advanced technologies, scientific advances, and d a highly complex research and development enterprise. It provide wide range of manufacturing services to biopharmaceutical companies. Biopharmaceutical contract manufacturing is widely used due to the complexity in manufacturing of biomolecules, as are considerably more complex, different in shape, size, and behavior than pharmaceuticals. Contract manufacturing organizations (CMOs) provide services from development of biologics to commercial scale production. Biopharmaceutical contract manufacturing involves the production of medicines in small units that can be customized to meet customer specifications. Contract manufacturers usually produce high quality and highly secure pharmaceuticals at low prices. The primary components of these drugs are plant materials and chemical substances. Biopharmaceutical companies are focused on producing numerous pharmaceuticals for the pharmaceutical industry. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/biopharmaceutical-contract.html

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

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Overview: Become knowledgeable and understand the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law, Excluded Individuals and additional criminal/civil laws that may worsen the punishment if these laws are violated. Understand the criteria of each law, exceptions and how to identify an issue that requires mitigation. Why should you Attend: Are you able to distinguish with certainty an agreement, contract or activity that is permissible versus one that is not under our current healthcare laws and regulations? Do you have a contract organization system where reviews are done regularly and retained centrally? Do you conduct auditing and monitoring of potential high risk compliance areas related to fraud, waste and abuse? If you are uncertain or need additional guidance on recognizing potential violations of healthcare fraud, waste and abuse regulations and how to audit and monitor for non-compliance, this training is for you. Areas Covered in the Session: Define and describe elements of the Anti-kickback Statute, False Claims Act, Exclusionary Rule, Physician Self-Referral Law and potential penalties for violations Discuss exceptions and related criteria to the Physician Self-Referral Law and the Anti-Kickback Statute Identify common potential issues that may result in violations and how to avoid or mitigate them Provide examples on how to comply with the regulations Describe areas to audit, monitor and implement policies/procedures for compliance Who Will Benefit: Health care providers Revenue cycle management employees Coders, Billers Compliance officers Contract management Compliance and Internal Audit professionals Healthcare administrators 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 impr

Vial is a technology enabled Contract Research Organization (CRO) that delivers faster, higher quality trial outcomes.

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

Overview: Section 13411 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires Health and Human Services (HHS) to conduct periodic audits of providers and business associates to ensure their compliance with the HIPAA Security and Privacy Rule, and breach notification standards. To implement this mandate, the Office of Civil Rights (OCR) has conducted HIPAA/HITECH audit program with KPMG of 115 health care organizations to assess privacy and security compliance. This webinar will focus on the implementation and tracking of HIPAA audit best practices in a healthcare setup in order to prepare for the federal audit using published OCR audit protocols. Every audit begins with interviews, a questionnaire, and a thorough policy and procedures review. Presenter, with his decades of knowledge in the compliance, legal, auditing and security areas, will walk the attendees through the audit process, documentation requirements, and implementation specifications of the HIPAA privacy, security and breach rules. This presentation not only provides opportunity for the participants to prepare for the federal HIPAA audit but also to improve the security posture of their organizations by adopting to changing technology (mobile, social media, Health Information Exchange(HIE), cloud services, etc.) and threat landscape perspective as well. This presentation will uncover reasons why many health information breaches are occurring and help organizations better secure and comply with electronic protected health information by meeting the required and addressable HIPAA/HITECH security rules. The presenter will also share the best practices used for HIPAA security implementation and continuous risk assessment which is considered as "due diligence" by auditors for the HIPAA security compliance program. Areas Covered in the Session: Healthcare Technology Adoption/Trends Healthcare Regulatory (HIPAA/HITECH) and OCR/HHS Audit Overview Differences between

In this session Mr. Wolfe will provide an overview of the Stark Law and its 2016 changes. He will also discuss best practices for implementing and auditing physician compensation arrangements to minimize liability exposure and penalties, including conducting compliance audits, instituting policies, and establishing ongoing monitoring and review processes.

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

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

Overview: As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate. The HITECH Act, a recent update made to overall HIPAA regulations require Business Associates to comply with HIPAA mandates regarding the handling and use of health information. As a Business Associate you must comply with a wide-range of regulatory obligations, including certain privacy obligations, security standards, and breach notification requirements. If your business needs to understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure your current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive session. Why should you Attend: There is a lot of confusion about the role and requirements of being a Business Associate. Organizations must be prepared prior to entering into these contracts for services as a vendor and subcontractor. Attendees will leave the course clearly understanding of all the requirements that must be in place for the Business Associate - Covered Entity arrangement. After completing this course, a Business Associate will have a clear understanding as to 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 are the Consequences of being a Business Associate What is a HIPAA Compliance Program? What is a HIPAA Risk Mana

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

Cerebral palsy is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. Cerebral palsy primarily affects body movement and muscle coordination. Though cerebral palsy can be defined, having cerebral palsy does not define the person that has the condition.Cerebral palsy is a condition that affects thousands of babies and children each year. It is not contagious, which means can't catch it from anyone who has it. The word cerebral means having to do with the brain. The word palsy means a weakness or problem in the way a person moves or positions his or her body. Cerebral palsy is a common complication of very premature birth. The condition is a type of brain injury that causes problems with motor function. It's been a baffling disorder for doctors because of confusion over what causes the brain injury. CP Wheelchair: Ultra light weight aluminum alloy frame Epoxy powder coated frame Detachable arm rest provided Height adjustable and detachable head rest Hydraulic reclining high back for a comfortable posture Detachable back and seat pad Extra cushion upholstery provided to under arm, head. Hand brakes provided Safety belt provided Maintenance free rear solid wheels Cloth look like water proof upholstery Seat Width 14" Net Weight: 19.5 kgs An individual with cerebral palsy will likely show signs of physical impairment. However, the type of movement dysfunction, the location and number of limbs involved, as well as the extent of impairment, will vary from one individual to another. It can affect arms, legs, and even the face; it can affect one limb, several, or all. Cerebral palsy affects muscles and a person's ability to control them. Muscles can contract too much, too little, or all at the same time. Limbs can be stiff and forced into painful, awkward positions. Fluctuating muscle contractions can make limbs tremble, shake, or writhe. Balance, postur

Overview:   We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why should you attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party. They confirm the intentions and relationships of the parties as they enter into this relationship, and they eliminate uncertainties regarding mutual rights, obligations, and relationships. If everything remained as it is at the time the agreement is signed, there would be little need for formal documents. However, the agreement serves to protect against future disputes. Therefore, it should include as precise language as possible. Ambiguous terms in agreements are of little effect when disputes occur over the meaning of a party's rights or obligations. You should attend to gain an understanding of what should and what should not be in a physician employment agreement. Areas Covered in the Session: Corporate practice of medicine Term and termination Termination for Cause Severance pay Provision allowing physician to terminate for cause Severance pay Duties of the physician Standards for the provision of professional services Referral to hospital Continuing medical education Who Will Benefit: Physicians Healthcare executives Physician practice managers Speaker Profile William Mack Copeland MS, JD, PhD, LFACHE, practices health care law in Cincinnati at the firm of Copeland Law, LLC. He is also president of Executive & Managerial Development Group, a consu

Health Information Security Compliance: Health information security compliance requirements from HIPAA keep risk management at the core. These requirements also have other guidelines. Health information security compliance is a vital requirement for healthcare providers. Healthcare professionals have to ensure security and privacy of Protected Health Information (PHI) and Electronic Protected Health Information (ePHI), which are part of Electronic Health Records (EHR). The guidelines, rules and requirements are mandated by HIPAA, which is in charge of ensuring that there is privacy and security of health information. Challenges associated with health information security compliance The very fact that a lot of health information is stored in electronic records makes health information security compliance all the more challenging. The way in which information flows between various players in the sector is also a factor: shared computers and information sharing with third party associates like laboratories and billers. If a healthcare organization is not compliant with health information security, it could be held indirectly responsible for issues arising out of these. HIPAA has regulations and guidelines on how providers can keep PHI and ePHI. It suggests and strongly recommends risk analysis as the basis for health information security compliance. These are set out in the Meaningful Use requirements. Some of risk analysis methods include or relate to the following: The provider's EHR software and hardware Assessment of whether the provider's practice protocols are adequate Risk assessment of the provider's physical setting and environment Risk assessment relating to staff education and training A thorough examination of EHR access controls Risk management relating to contracts with the provider's Business Associates The healthcare provider's practices in relation to patient relations and communications Physical measures for ensuring health information security c

Overview: Hospital chargemasters are complex and represent a key component for the revenue cycle of hospitals. Chargemasters are intertwined with coding for services, billing for services, charging for services and even involve the cost reporting process. A myriad of decisions must be made concerning how the chargemaster is organized, impacts on coding and billing, charge structuring, cost accounting, and other processes within the revenue cycle. Whenever decisions are made, policies and procedures should be developed, approved and implemented. A proper system of billing and chargemaster policies and procedures can help to maintain an appropriate compliance stance in a world where ambiguous guidance is often the norm. The development of charges and charge structuring within the chargemaster is a major issue often referred to as transparent pricing. While even the Medicare program maintains that hospitals should charge for everything, the way in which charges are set and amalgamated at the claim level can vary significantly between hospitals. A key issue for the chargemaster is differentiating separately charging from separately reporting. The way in which hospitals make decisions about the bundling of charges at the line-item level within the chargemaster leads to many decisions, all of which need justification through proper policies and procedures. Due consideration must be given to departmental concerns about revenue generation, cost reporting implications, coding implications and any associate challenges with billing and claims filing. Why should you Attend: See Typical Questions - Here are some reworded marketing questions: Why are the chargemaster and hospital billing targets of compliance audits? How should we prioritize statutory and contractual compliance for the chargemaster and billing process? Will chargemaster and associated billing policies and procedures give us protection relative to compliance? How should we develop a system of chargemaster po

What causes nausea and how can you avoid/treat it at home? You feel nauseous when your stomach either stops contracting or... Ever wonder why you feel so uneasy while driving across a rough, bumpy road? How does nervousness lead to nausea? Patients with nausea make up 6.7% of all cases treated...

Today was an exceptionally bright day. At least the morning. The rest of the day was marred by Kate throwing up on me nonstop. She felt a strong sensation of nausea and dizziness. But why does she eat at that weird Mexican place when she knows it makes her stomach sick? Every time she goes there, she feels a gut-wrenching, stomach-turning urge to release all that her belly holds. I mean, the stomach is an elastic bag made of muscular walls containing acid. We read that in science once. But why does Kate's stomach hold a serious grudge against Mexican food?

ASP Cares HIV Speciality Pharmacy is highly recommended by the physicians treating the HIV patients as a contract pharmacy of high reputation. With nationwide 503B sterile compounding facility and 340B partnerships, we provide a comprehensive medication regimen with insurance support and strict delivery schedule.

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

Hepatitis and Hepatitis C are two of the most common forms of hepatitis and both are caused by different viral strains. Various companies are involved in developing a new drug for treating Hepatitis C due to the growing patient pool. The disease is caused by a virus that can be transmitted from person to person and can be acquired either through ingesting an infected person's blood or inhaling their infected air. Hepatitis is caused by a strain of the virus which is not transmitted from one person to another and is caused by a genetic defect. Hepatitis is caused by the human papillomavirus (HPV), while hepatitis C is caused by a variety of different strains of the virus called HCV. Hepatitis can be caused by a single strain of the virus, although some cases have been known to be caused by multiple strains. It is also possible for a person to contract one form of the virus, then develop a secondary infection which is caused by another form of the virus. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/hepatitis-c-drug-is-gaining-prominence.html