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Regulatory Affairs Courses

  • Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You.

    Just because a product claims to be natural doesn’t necessarily mean it’s safe, says Gary Coody, R. Ph., FDA’s national health fraud coordinator. Likewise, just because a product claims to be natural does not mean that it’s free of hidden drug ingredients.

  • 20 October 2015
    BESTOWING PHARM.D TO THE ERA OF HEALTHCARE TECHNOLOGY AND PATIENT SAFETY

    ABOUT AUTHORS:
    Tarun Singh
    India’s Leading Drugs Consultant
    SSJ Hospital
    doctarunsethi@gmail.com

    Advancement in health and medicine has enhanced the life expectancy of human beings. For last hundred years' medicinal processes and medical equipment are proved to be the boon to human health for diagnosing properly and for applying proper medicines to the patient.

    Medicine is considered as one of the most important necessity to all of us. It is derived from the Latin words arsmedicina meaning "the art of healing". Medicine and Drugs are the synonyms.  Drugs is concerned with maintaining or restoring human health through the study, diagnosis, treatment and possible prevention of disease, injury and other damage to a body or mind. It ignites the human mind to initiate more research to find other sophisticated technology for adding value to medical science. Due to consistent effort of doctors and scientists now we have latest medical equipmentfor diagnosis, High quality medicine packaging machines, Computerised blood testing machines, digital & robotic testing machines.

  • Healthcare, education and law & order are thought to be the main concerns of nation-states across the world. The Indian state has traditionally been unable to meet any of these but the healthcare challenge seems particularly acute.

  • 8 October 2015
    Gluten intolerance: Dangerous gut-wrenching experience for some (Health Feature)

    For people in large areas of the country, a supper without chapati is simply unimaginable. What most of them probably do not know is that a protein that gives the dough a subtle elasticity to get a final chewy texture can herald a bouquet of health problems in the long run.

  • 5 October 2015
    Mammograms - everything you need to know

    What is a mammogram?
    A mammogram is an x-ray picture of the breast.
    Mammograms can be used to check for breast cancer in women who have no signs or symptoms of the disease. This type of mammogram is called a screening mammogram. Screening mammograms usually involve two x-ray pictures, or images, of each breast. The x-ray images make it possible to detect tumors that cannot be felt. Screening mammograms can also find microcalcifications (tiny deposits of calcium) that sometimes indicate the presence of breast cancer.

  • 22 September 2015
    IMPACT OF RIGHT TO EDUCATION (RTE) ON ACCESS AND QUALITY OF EDUCATION

    ABOUT AUTHOR:
    Nirav Rajendrakumar Soni
    M.Pharm (QA), PGDIPR
    Ahmedabad, India
    nirav_sonic@yahoo.com

    ABSTRACT:
    The importance of education cannot be denied in one’s life. It sustains the human values which supply to the individual and collective good. The relationship between universal human rights and educational equity and access within the context of the educational system It forms the origin for lifelong learning and inspires buoyancy to face challenges. It will give the skills to individuals to become more self-reliant and aware of right opportunities. It also enhances the ability of individuals to act more responsible and more informed citizens and have a voice in politics and society, which is essential for sustaining democracy. The importance of primary education has been neglected by India since independence knowingly or unknowingly. However, Government of India now is willing to improve primary education by bringing legislation i.e. Right to Education. But efforts through Right to Education (RTE) to improve the quality of school education seem to be yielding little result. The learning outcome in reading, writing and arithmetic is becoming poorer and enrolment in private schools is improving significantly, indicating a growing distrust of the common man against state-run schools in the country. This paper tries to bring out the meaning of much awaited Right to Education (RTE) 2009, act and tries to bring out the critical appraisal of the Act after five years since its passage.

  • 11 September 2015
    REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN CHINA

    { DOWNLOAD AS PDF }

  • 10 September 2015
    KEEPING TRACK OF SAFETY IN THE GLOBAL PHARMACEUTICAL MARKET

    Product Inspection Challenges for Multinational Pharmaceutical Organisations

    ABOUT AUTHOR:
    Neil Giles
    Marketing Communications Manager,
    Mettler-Toledo Product Inspection, UK

    The global pharmaceutical industry is booming. While North America still leads production with 41% of world pharmaceutical sales, Europe is catching up with 26.7%.[1] According to the European Federation of Pharmaceutical Industries and Associations, the European market alone generated more than 205 billion Euros in 2011, with Italy contributing about 25 billion.[2] The worldwide healthcare industry is further boosted by growing market and research efforts in emerging economies such as Brazil, China and India, leading to a gradual migration of economic and research activities from Europe to these fast-growing markets.

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