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  • Main Subject - The Risk of Being 'Remote' Translator

    Technology makes life easier. It supposed to be like that in an ideal condition. U
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    nfortunately, there is always risk that we have to face (and fight) because nothin
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s perfect in reality.

    Of course we have to admit that internet has broadened chan
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    es to do many things without going nowhere. Everything could be done in our privat
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    room. I have been doing translation works (English - Indonesian, vice versa) for
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    everal years and everything is done in a small room where I sleep and I work. My b
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    droom is my office too and nothings wrong with that :-)

    I don't have to wear suit
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    and tie or shoes while at work, for my clients are somewhere out there. They don't
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    care whether I wear shoes or not, or if I wear clothes or not. The most important
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    hing for them is how I do my job. They only need to have a good translation, and t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    at's all. On the other hand, what I have to do is doing my best to make them satis
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ied and get a good payment. That's all.

    The problem is sometimes I find some clie
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ts who try to cheat me. Most 'cheaters' try to delay my payment. There's always a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hance to have such annoying thing because no technology can help me to test if my
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    lient is honest people or not. We never meet each other and the working relation i
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    purely based on good-will and trust. Lucky me, not so many people like that. When
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    I stuck to people like this, the best thing I can do is to add this one to my blac
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    list.

    Risk is a part of life. Nothing in this world is 100 % safe with no risk.
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    rust me, most people are good and only the rest or the smaller part are bad. As lo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    g as I do my best, I do believe that nobody can steal my livelihood given by God.


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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