Health Care

Regulatory requirements for medical devices and IVD (invitro diagnostic) kits in India

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This course is developed with the help of subject experts by Clinical Development Services Agency (CDSA), an extramural unit of Translational Health Science & Technology Institute (THSTI), Department of Biotechnology, Ministry of Science & Technology, Government of India. The course has been reviewed for it’s content and quality by Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India. Demonstration of safety and efficacy of medical device and in vitro diagnostic (IVD) kit for use in humans is essential before the product can be approved for import or manufacturing and marketing in the country. Medical devices are currently regulated under the definition of DRUG. The Rules are:-Rules 109-A - Labeling of medical devices Rule 125-A - Standards for medical devices Schedule M III - QMS requirements Schedule R- Standard for mechanical contraceptives Schedule R1-Standards for medical devices Schedule DII -Annexure B – IVD Recent amendments made under the Medical Devices rules & “Medical Devices Rules 2017’’ [G.S.R. 78 (E) Dated the 31st January 2017] are published and are mandatory w. e. f. 1st January 2018.Upon completion of this online course, the trainees will understand: Medical device and in vitro diagnostic (IVD), classification and types of medical devicesStandards of medical device and testing, personnel involved, Quality Assurance, Quality Management SystemManufacturing license, inspection, fees, import, export, etc. 

交通事故被害者生活支援教育 (ga075)

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世界的に見ても比較的平和と言われる我が国において、交通事故は「日常のありふれた中に潜む危険」であり、誰もがみな、いつでも、交通事故の加害者や被害者になる可能性を持っています。現代社会は、移動や流通などの交通社会が発達したことによる利便性を享受して生活しています。そして、その利便性を放棄することは誰も望まないでしょう。しかし、その裏で交通事故による死亡者数は減少傾向にあるとは言え、毎年50万件以上の交通事故が、そして毎年60万人超の負傷者が発生しています。そこに、交通社会の中で被害に遭われた方やその家族を社会で支えていかなければならない理由があります。この講座では、医療や福祉の現場で働く専門職の方だけでなく、交通事故被害者の生活支援に当たろうとする全ての方を対象に、社会資源の理解や医学的知識、そして心理的サポートなどの支援に必要となる基礎的な知識を分かり易く、且つ効率的に身に付けるための講座です。

Upgrading and Monitoring the Apigee Hybrid API Platform

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Class Central TipsLearn How to Sign up to Coursera courses for free1600+ Coursera Courses That Are Still Completely FreeThis course discusses the upgrade process for Apigee hybrid, and teaches you how to monitor and troubleshoot the hybrid runtime plane components.

Electronic Systems for Cancer Diagnosis

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This course is designed with an aim of educating students on the process flow for designing electronic systems for tissue-based cancer diagnosis. An exposure towards developing strategies to discriminate pathological cells from normal ones based on the electrophysiological properties of cells. Design and integrate biochip with electronic module for understanding the electro-thermo-mechanical properties of tissues. microtechnology and its use to fabricate sensors and systems. Students will have an exposure towards how to fabricate the sensors and its application in real world. Several examples of engineering devices used in clinical research will be also covered. Both conventional (class 1000) and non-conventional (class 10000) clean room and some equipment within it will also be shown. Below are some of the course outcomes.The first objective of this course is to understand cancer and its properties: Breast Cancer and Oral CancerThe second objective is to educate the students on the process flow for designing electronic systems for tissue-based cancer diagnosisThe third objective is to develop skills to design electronic systems for cytology-based studiesFourth objective is to develop skills to integrate biochips with electronic system for cancer diagnosisThe fifth objective is to understand how to work in a conventional (class 1000) and non-conventional (class 10000) clean room environment and understand several equipmentsThe final objective is to learn and understand in detail how to design electronic systems with the preexisting knowledge of basic electronics and to add on the 3D printing skills.INTENDED AUDIENCE : Engineering Students, Faculty from Engineering CollegesPREREQUISITES : Basic Electronics/MicrofabricationINDUSTRY SUPPORT : NILL

Kesehatan Anak: Mengerti Alergi, Pencegahan dan Mitigasinya

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Tentang KursusKursus ini akan membahas tentang Kesehatan Anak: Alergi, Pencegahan dan Mitigasinya. Kursus ini terdiri dari empat minggu kursus yang akan diisi oleh Prof. Budi beserta tim. Mengetahui alergi pada anak adalah hal yang penting dalam membangun keluarga yang sehat. Mempelajari tentang pencegahan serta mitigasi dari alergi tersebut merupakan hal yang baik untuk dilakukan.Terdapat forum diskusi pada kursus ini. Siswa dapat memberikan tanggapan maupun pertanyaan pada forum diskusi tersebut. Silahkan ajak rekan yang lain untuk aktif dalam form diskusi.Selamat mengikuti kursus.

Psycho Social and Family Issues of Individuals with Visual Impairment

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Give brief about course content / curriculumThis course familiarizes the learners about the issues of Individuals with Visual Impairment and related to Psychological and Sociological Implications of Visual Impairment. In addition this course focuses the Challenges faced by Visual Impaired persons and their Rehabilitation, Community Involvement for Inclusion. Besides, the course describes the involvement of parents along with teachers in the preparation of individualized education plan for their wardAfter completing this course, the student-teachers will be able to• describe the effect of birth of a child with visual impairment on the family• analyze the role of family and parental concerns related to their child with visual impairment from birth to adulthood• explain the role of parent, community partnership in the rehabilitation of a person with visual impairment• develop different skills to empower families in meeting the challenges of having a child with visual impairment• counsel the parents and the members to foster the education of visually impaired\• tap support from family of the visually impaired in early stimulation, concept development and early intervention• involve parents in Individualized Education Plan(IEP) and Individualized Family Support Plan(IFSP)• be familiarize with the legal provisions and concessions pertaining to visual impairment• enhance prosocial behaviour among children with visual impairment

Become a Healthcare Project Manager

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Privacy concerns and regulatory constraints are common roadblocks for healthcare project managers. This learning path will prepare you to meet those challenges, as well as provide you with a foundational knowledge to be an exceptional project manager.Build a strong foundation in project management skills.Identify common stumbling blocks for healthcare project managers and best practices to overcome them.Practice techniques to increase your project management efficiency, leadership, and business acumen.

Advance Your Data Science Skills in Health Sciences

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Build extensive data science modeling and analysis skills for working with scientific research concepts. In this learning path, discover the tools of the trade, and learn how to apply what you learn in real-world data project environments and platforms.Build a solid skill set using Python in healthcare research.Explore commonly-needed skills and analytic techniques using R.Develop advanced skills in designing healthcare studies.

Economics of Health and Health Care

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When I was doing my doctoral research in the area of Health Eonomics several people asked me that What does this Economics in Healthcare mean?” Health economics or Economics of Healthcare is a discipline of economics which is concerned with the association between health status and the related resources assessing the value, behavior, efficiency and effectiveness of various stakeholders in the production and consumption of healthcare. Pertaining to several factors Health Economics has not been studied well in India or in many other developing countries, unike the developed economies.Learning Objectives:1. To provide the students a broad understanding about the fundamental economic concepts in the area of health, health care and health policy.2. To equip students with economic theories and logics in order to analyze the behavior of different economics agents at the individual, household, community and institutional (government and non-governmental) levels within thehealthcare market frameworks.3. To help them to build rationale and strategies based on the economic valuation of healthcare system and the measurement of efficiency level.4. To learn about the shortcomings of a lowly developed economy to attain best health status and the health and development nexus.5. To understand the healthcare financing mechanism and its evolution.INTENDED AUDIENCE:Post-graduate studentsPREREQUISITES: NIL.INDUSTRY SUPPORT: Public Health Organizations, Hospitals, Allied Healthcare Providers, Pharmaceutical companies, NGO.

Take the Lead on Healthcare Quality Improvement

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Class Central TipsLearn How to Sign up to Coursera courses for free1600+ Coursera Courses That Are Still Completely FreeIn this course you will learn about the importance of quality in healthcare and how you can contribute by implementing a quality improvement (QI) project to improve processes of care and patient outcomes. You will learn about powerfultools to add to your QI‘toolbox’ during short lectures and reflective exercises. You will apply these tools to the implementation of a QI project in your own practice setting or an area of personal improvement. At the completion of the course, you will have a storyboard that captures your QI project success to share with others.The QI project will be considered within the context of interprofessional teams and from a systems perspective.The objective of this course is to empower you, the working healthcare professional, to improve your knowledge and skills in the science of quality improvement so that you can take action in your own clinical setting to improve the quality of care for your patients and their families.

Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)

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Medical devices and IVDs are an upcoming area and there are lots of new developments. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have a profound impact. Being an online course will address a larger section of the public. Making it a ‘free course’ will allow many to acquire knowledge in the comfort of their home without paying any money. Demonstration of safety, efficacy, and performance of the medical device and in vitro diagnostic (IVD) kit for use in humans is essential before the product can be approved for import or manufacture and marketing in the country. Medical devices are currently regulated under the definition of ‘drug’. Recent amendments made in the Rule by incorporating specific rules i.e. “Medical Devices Rules 2017’’ [G.S.R. 78 (E) dated the 31st January 2017] are published and are mandatory with effect from 1st January 2018. These Rules provided requirements for import, manufacture, clinical investigation, medical device and in vitro diagnostics. All these had been effectively addressed in this course launched in early 2019 with 10 lectures as a four-week course. This online course (version 1.0) was attended by 657 participants (Jan - Mar 2019). A brainstorming series of discussions were steered by CDSA with CDSCO for incorporating the new updates. The feedback received from version 1.0 participants were sought. Also, the deliberations from various face-to-face programs on medical devices and IVDs that were conducted by CDSA and CDSCO were incorporated to decide the content for version 2.0. This now had 12 lectures spread over 4 weeks (online course). This will involve 4 weekly assignments and a final exit assessment. 4 new lectures have been added in version 2.0INTENDED AUDIENCE : • Medical device industry• in vitro diagnostics (IVD) manufacturers• Innovators or start-ups involved in either medical device or IVDs• Regulatory affairs personnel• Human ethics committee members• Clinical trial/research team members• Any person interested to acquire knowledge in this areaPRE-REQUISITES : There is no pre-requisite to undertake this course.INDUSTRY SUPPORT : Medical devices, IVD companies,Research/Academic Institutions, Biomedicalresearch organizations, Regulatory authorities, Medical colleges, Contract research organizations

Creating Your Own Jazz Lines Series

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Lessons on creating jazz lines and improving your performance on the saxophone.

Transitions in Care from Survivorship to Hospice

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Class Central TipsLearn How to Sign up to Coursera courses for free1600+ Coursera Courses That Are Still Completely FreeThis course should be taken after the Symptom Management course and continues building your primary palliative care skills – communication, psychosocial support, goals of care, and symptom management. You will explore transitions in care such as survivorship and hospice. You will learn how to create a survivorship care plan and how to best support a patient. The course also covers spiritual care and will teach you how to screen for spiritual distress. Finally, you will learn the requirements for hospice care and practice discussions difficult conversations related to end-of-life care.Stanford Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Visit the FAQs below for important information regarding 1) Date of original release and Termination or expiration date; 2) Accreditation and Credit Designation statements; 3) Disclosure of financial relationships for every person in control of activity content.

Addressing Violence Through Patient Care

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Understand the methods and importance of medical peace workOn this course you will learn about some of the key concepts and challenges in the field of medical peace work, particularly the importance of violence prevention and peace practice for healthcare professionals.You will cover aspects of theory, field work and advocacy focusing on working with domestic violence, refugee healthcare and healing torture victims. In each case you will consider the specific challenges of treating these victims of violence and the role you play in helping them.This course has been created for people with some experience in healthcare. It is particularly relevant to clinical healthcare professionals working in medicine, nursing, and allied health.

Principles and Applications of NMR Spectroscopy

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The objective of the course is to teach the basic aspects of nuclear magnetic resonance (NMR) spectroscopy, which is an important analytical tool in chemical and pharmaceutial industry for structural characterization of molecules. The topics to be covered will include one-dimensional NMR, Chemical shifts, J-coupling, Interpretation of 1D NMR spectrum, Basics of 2D NMR, Different 2D NMR experiments and their application/interpretation, Application of 2D NMR for assignment of molecules and peptides.INTENDED AUDIENCE :Students of M. Sc and Ph. DPREREQUISITES :Should have studied Chemistry at undergraduate level and Mathematics at least up to 12th StandardINDUSTRY SUPPORT :All pharmaceutical companies (e.g., Reddy's laboratories, CIPLA, Sun Pharma) and R &D laboratories like Hindustan Unilever, Biotech companies (Biocon)