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Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang

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

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

Food Safety and Security are two faces of the coin : Food safety and security are two different, but closely related concepts. Although part of the same aspect, they vary in their application and meaning. Both are equally important in ensuring that populations of the world get food that is sufficient and nutritious. Food safety and security are complete without each other. Food safety complements food security, and vice versa. Food safety : Food safety is essentially about the safety of the ingredients that go into food. If food is being sourced from a farm, the food makers have to ensure that the farm has ensured safety standards in producing this food. Food safety is concerned about the amount of chemicals and fertilizers used in production of food. It is also concerned with how much residual pesticide, which could cause harm to humans when the food that is grown using it, is left in the final product, and so on. Food safety is related to and is dependent on factors such as demographics, inputs that go into the cultivation and production of food, availability of water for production of safe food, the use of energy sources in the safe production of food, climate change, etc. Now, food security : Food security, on the other hand, is about more about the food supply chain. When food arrives from the producer to the consumer, it goes through a complex chain that can many times span entire continents. Food may also be sourced and consumed locally. In either case, there is a need to ensure that the points that food travels in and reaches are secure. Ensuring quality throughout : The aim of food security is to ensure that food which travels through many chains and stages should be clean at all these stages. This means that security has to be ensured from rodents and other forms of disturbances at the agricultural fields in which food is produced, then at the granaries in which it is stored, at the routes that it travels, then at the location at which food is pr

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

Overview: In this webinar, Hope will present the lessons she's learned over her career as a grant writer and editor in medical research. By identifying simple solutions to common problems, participants will learn tools to improve their ability create competitive grant applications and increase their academic and research productivity. To write compelling grant applications, this webinar will cover: How your choice of words will help you stay within page limits without compromising the science How to minimize abbreviations to improve readability and respect reviewer time constraints How to use Microsoft Word efficiently to improve page layout and readability How to manage references by enlisting online databases and reference management software How and when to stop developing the content to meet both grantor and institutional deadlines Why should you Attend: Many Grant Writing workshops do not teach writing per se. Though useful for beginning grant writers, most focus on understanding the application process and the various sections of a grant. For participants wanting to learn to actually write a grant, they are often left to figure out the technique for themselves. In addition, funding opportunity applications (FOAs) have changed quite rapidly in the past few years and require more focused writing in fewer pages. Competition has increased as budgets have shrunk, and knowing how to make the most out of both the time and the length of a grant project can prove challenging and extremely stressful. This webinar is for both new and experienced grant writers, either scientists and principal investigators or writers and other support staff. By using common resources (MS Word, EndNote, PubMed), the webinar content is designed to help grant-writing teams increase their efficiency in the writing process and also meet the requirements of the FOAs. Plus, plain language and good writing practices taught in this webinar will ensure straight-forward, content-rich, and well

Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the new 2016 audits. We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in the new round. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked. In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the new, increased fines and new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity. The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary

Patient Safety in Medical Education A very important aspect of medical education that had been overlooked for a long time is patient safety. When patient safety in medical education gets relegated to the backseat; the result is there for everyone to see: something like close to a 100,000 deaths at the turn of the previous century, according to the alarming results of a comprehensive study carried out by the Institute of Medicine. The tragedy of these deaths is that these were preventable. This reinforces the belief that patient safety in medical education is the core factor, which if handled properly, can save thousands of lives. How does patient safety in medical education come about? It goes without saying that physicians and other caregivers practice in their professions what they learn in schools. So, patient safety in medical education has to be incorporated into the curriculum at the earliest stages. Hospitals, medical colleges and other institutes that impart medical education have now started taking more than mere baby steps in inculcating patient safety in medical education as a core part of teaching, the already heavily burdened curriculum in medical education notwithstanding. Efforts by medical education bodies Following the publication of the IOM report, the American Association of Medical Colleges (AAMC) and the Curriculum Management and Information Tool (CurrMit) in the US and Medical Schools Council and the General Medical Council (GMC) in the UK sprang into action, announcing a slew of measures aimed at bringing about and reinforcing patient safety in medical education. Entire lessons and chapters are devoted to patient safety in medical education. Keywords and technical jargon relating to patient safety are now a highly visible aspect of patient safety in medical education. These are spread across all disciples and subjects of medical education, be it gynecology or anesthetics. What should curricula teach about patient safety in medical edu

Overview: Have you ever had a student who was excessively dramatic or who repeatedly monopolized discussions in a know-it-all, domineering, or aggressive fashion? Perhaps you've encountered a student who was so odd or anxious that they weren't able to participate in group activities or complete assignments. It's hard to know what to do when a student's personality just seems to take over your class, but you can't just stand by and do nothing. If they are not managed effectively, students with personality disorders take up a lot of time and can move your whole class in counterproductive directions. Sometimes these challenging students have a Personality Disorder, which is a persistent pattern of perceiving, relating to, and thinking about the environment and themselves that is maladaptive, rigid, pervasive, and enduring. Personality Disorders also manifest in the student's emotional response and impulse control and can negatively impact classroom teaching and learning as well as a student's personal and academic success. Unless you are a particular student's psychiatrist, it's not your job to diagnose them as having a personality disorder, but it is helpful to recognize and understand signs of a personality disorder. This webinar will identify different personality disorders and review their common traits and characteristics. You will learn essential tools for dealing with Personality Disorders such as boundary setting, clear communication, and effective classroom management. In addition, you will review relevant mental health resources and when and how to make appropriate referrals to counseling, accessibility services, and student conduct. Why should you attend: If students with personality disorders are not managed effectively, their behavior can have a negative impact on teaching and learning. Areas Covered in the Session: Ten types of Personality Disorders Prevalence and Demographics Developmental issues Common traits and characteristics of Personality Dis

HIPAA Breach Notification Rules and its new version : Let us begin at the beginning: What is breach notification? The term is pretty simple to understand. It means notifying the authorities whenever there is a breach of Protected Health Information (PHI). Covered Entities (CE's) and Business Associates (BA's), who are closely associated with PHI, and individuals whose PHI data are breached, are required to bring such data breaches to the notice of the authorities, whenever there is one. A breach notification is a mechanism that is aimed at ensuring that BA's and CE's meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA). To whom should the affected individuals and CE's and BA's complain? Whenever there is a breach of PHI by a CE or a BA, or if there is violation of the Privacy, Security, or Breach Notification Rules, the affected individual can complain to the Office for Civil Rights (OCR), which will initiate investigation into these complaints. Whenever a CE or a BA detects a breach, it can complain to the Secretary of Health and Human Services (HHS). In addition, the HIPAA breach notification rules have clear guidelines on how to report breaches in the following classifications: HIPAA's definition of a breach A breach of PHI is said to have taken place when any unpermitted use or disclosure that compromises the security of the data in the PHI takes place. Any such action, resulting in the breach of any kind of data contained in a PHI, big or small, is considered a breach, unless the CE or BA can explain that the data that got breached into was not serious enough, from its risk assessment point of view, to warrant immediate intervention. The new HIPAA breach notification rules The HHS embarked on a new HIPAA breach notification program, the HIPAA Privacy, Security, and Breach Notification Audit Program, with which it seeks to bring a few changes into the existing HIPAA breach notification rules. This new Audit Pr

The emerging discipline of Hospitals Management Performance Assessments Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics to evaluate the critical functioning levels of hospitals. The topic of Hospitals Management Performance Assessments came to acquire proper shape and structure following the heavy reference the WHO made to this discipline at the WHO European Ministerial Conference on Health Systems of June 2008. The following year, it found resonance again, when it was the theme of the World Health Day. The evaluation of Hospitals Management Performance Assessments Hospitals Management Performance Assessments started to evolve primarily to provide healthcare professionals with a tool to diagnose the quality of performance of the hospitals and other healthcare settings they work in. It was felt, over time and experience, that when strict appraisals were being made in many areas of healthcare, a set of parameters to assess the level of efficiency of hospitals would go a long way in ensuring the implementation of enhanced processes, leading to better patient outcomes. Areas of concentration for Hospitals Management Performance Assessments The core disciplines in which Hospitals Management Performance Assessments sought to bring about measurable and verifiable improvements were: The PATH approach As a result of discussions and deliberations the WHO held with many countries, primarily European, a path for charting out the course of Hospitals Management Performance Assessments was concretized in the form of what the WHO called the PATH - the Performance Assessment Tool for Quality Improvement in Hospitals. A brief understanding of PATH PATH

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

Tynor R O M Knee Brace Prefabricated, custom adjusted R.O.M. Knee Brace controls and restrict flexion/extension of the knee joint through a multi-point joint fixation system to allow a range of motion or immobilization to the knee. Universal design allows it to be used on quite a big range of population and for a multiple orthopedic problems associated with knee joint. Immobilization at any angle Controlled motion between any two angles Quick and easy application and removal. Tynor R O M Knee Brace Features R.O.M. Dial 0 to 120 degree flexion. 0 to 60 degree hyper extention Locking at any angle or motion between any two angles possible Interval of 10 to15 degrees Pleasurable locking, using easy pull mechanism Neoprene Liner with Silicone Coating Enhanced product grip Less slippage of product High cushioning coefficient and more comfort Less discomfort of tight straps Ergonomic Design Light in weight Bilateral symmetrical Improved patient compliance Easy removal and application Universal design, one size fits all Straps with Reverse Buckle Mechanism Enhanced grip Easy to wear Controlled tightening.

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

A Basic Understanding of Shipyard Workplace Safety Shipyard Workplace Safety is a high importance, high criticality area for safety regulation. This is so because shipyards are among the most hazardous of places to work in. it is estimated that at any point of time, the number and incidences of injuries and fatalities in the shipyard industry is at least twice that of the next most hazardous industry, construction. This calls for urgent and important Shipyard Workplace Safety regulations. Present Shipyard Workplace Safety Regulations OSHA has a number of Shipyard Workplace Safety regulations for this industry. These need to be read with CFR Title 29 Code of Federal Regulations (CFR) Part 1915, which not only lay out regulations, but also prescribe codes and methods of implementation of these regulations. Why these two regulations need to be implemented together is that there may be a few hazards not covered by Shipyard Industry standards set out by OSHA. These gaps are covered by the regulations set out in CFR 1915, making these a well-rounded set of regulations for Shipyard Workplace Safety. The need for Shipyard Workplace Safety regulations The need for Shipyard Workplace Safety is acutely felt because of the sheer variety of hazards that present themselves in shipyards. Shipyards, which employ between a few dozen and a few thousand employees each, are a site of potentially serious accidents. Even if accidents do not occur, the very nature of work done at these shipyards can be dangerous and hazardous. Shipyard Workplace Safety is a core requirement that employers in this industry have to keep in mind and put in place. The nature of their work could range from and include any or many of these: Scrapping Demolition Electrical Fabrication Creating large and heavy steel or iron plates, sheets, beams, pipes and related items Soldering Drilling Dealing with propulsion systems Welding Shipyard Workplace Safety has to begin with an understanding of these issue

OSHA's Standards on Fire Protection in the Workplace : When it comes to Fire Protection in the Workplace; there are several guidelines to be followed. One could go by common sense, but it is not usually sufficient, which is why OSHA has standards relating to Fire Protection in the Workplace. Like it does for all its safety requirements; OSHA requires the employer to take obligatory steps for the protection of employees from fire. These are covered in Title 29 of the Code of Federal Regulations Part 1910 Subparts E and L; and Part 1926 Subparts C and F. Employer obligations are the core of Fire Protection in the Workplace Requiring employers to carry out roles during a fire emergency and training employees towards the same are the foundation of OSHA standards on Fire Protection in the Workplace. Training employees on OSHA's standards on Fire Protection in the Workplace entails training them on all the core areas of handling a fire: The ways of using fire exits The ways of using fire extinguishing equipment The ways by which to organize an emergency exit plan The ways of using fire exits: Fire Protection in the Workplace on fire exits involves having to put in place a well-designed exit route for employees, so that they escape during a fire easily. These should be done keeping in mind the structure of the building. Keeping the exit route free of obstacles is another important requirement of OSHA's standards on Fire Protection in the Workplace. The ways of using fire extinguishing equipment: Having portable fire extinguishing equipment is not mandatory for OSHA, but employees must be properly trained on their use, should an employer have one. These equipment have to be placed at a convenient location for everyone to access easily. The ways by which to organize an emergency exit plan: An emergency exit plan is required as part of Fire Protection in the Workplace for some kinds of employers. It is for those whose activity involves the heavy use of hazardous chemica

Understanding Medical Identity Theft and ways of preventing it Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry. medicalIdentityTheft The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to impersonate and manipulate data. Why do crooks steal medical data? Medical Identity Theft happens mainly because hackers and mischief-makers access protected data to lay hands on confidential information about patients, using which they obtain medical care on behalf of the person/s whose records they steal or purchase expensive medicines. In many cases, a Medical Identity Theft is detected only after one gets a bill for a purchase or service that was never made. medicalIdentityTheft Medical Identity Theft is also committed to buy drugs and obtain fake bills that are then submitted to Medicare in the name of the original holder of the medical record. These acts can significantly dent a person's credit rating. More importantly, when wrong information or fictitious diagnosis is made into the medical record, it can lead to dangerous consequences. Ways of protection of medical data The Office of the Inspector General (OIG), which comes under Health and Human Services (HHS), realizing the gravity of the problem of Medical Identity Theft, has formulated the "3D" approach to protect medical data and prevent Medical Identity Theft. These are: Deter: One of the ways of protecting medical data is to prevent Medical Identity Theft. Users should be cautious about parting with information to anyone who claims, over phone, to have a new scheme whose enrolment requires the Social Security Number. Detect:Many fraudsters accost people at accessible public places to announce supposedly "new" medical schemes. Governm

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

Overview: This presentation will introduce the participants to changing role of the panoramic x-ray machine in dental offices today. Its expanding role in extra oral exposures and enhanced diagnostic capabilities is forever changing the path of dental x-ray imaging. Digital radiography is rapidly improving in diagnostic quality and loweringthe radiation exposure with ultra-low dose technology. We can have extra oral 2D bite wings and periapical x-rays with less radiation and greater diagnostic capability than traditional intraoral x-rays. The time has come that all dentists should have access to 3D-Cone Beam Computer Tomography. It is rapidly becoming the standard of care. Why should you Attend: Digital radiography is rapidly changing in today's dental offices. The new technology is revolutionizing patient flow and improving diagnosis. Dr. Jesek is at the forefront of this technology, using both 2D and 3D radiography. Seminar attendees will get easy to understand approach, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: CBCT can be used to in areas of general dentistry to improve patient acceptance and quality of treatment outcomes. General and Restorative Dentistry Oral Surgery Implant Dentistry Endodontics Periodontics Orthodontics Sleep Apnea/Air way Who Will Benefit: Dentists Hygienists Assistants Speaker Profile : Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1979. Unique to the area, his practice houses a crown and bridge laboratory with three technicians focusing on CAD/CAM milling technology to produce metal-free inlays, crowns and bridges. Dr. Jesek continued his training

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives