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  • Subjects - Does My Bum Look Big in This?

    If a good manager asks his workforce for their opinion of him he will receive their expressions of app
    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
    roval and be satisfied that he is doing a good job.

    If a bad manager asks his workforce for their opi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    nion then he too will receive their expressions of approval because as we all know, the best way to ge
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    t a bad manager off your back is to agree with him.

    The problem for the manager is how to find out if
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    he is good, and adding value to the organisation, or if he is bad, interfering and preventing the wor
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    kforce from performing tasks that they are perfectly capable of doing well on their own.

    To get hones
    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
    t feedback we have to be able to look in the mirror.

    The problem the boss faces is that his own behav
    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
    iour distorts the reflection away from the true one towards the one that the workforce thinks he wants
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    to see.

    If a boss asks his workforce what they think of him the answer will be coloured by the fact
    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
    that the boss is the person who decides wage increases, promotions and allocation of work.

    The employ
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e is going to find it very difficult to tell his boss something that he does not want to hear.

    The re
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    sponsibility therefore lies with the boss to create the environment in which the employees can provide
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    a true reflection

    This requires an understanding of what behaviour the boss exhibits that stops the
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    employee providing a true reflection and the discipline to once having identified this behaviour, stop
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    doing it.

    What is the required answer to the question, Does my bum look big in this?

    And what is th
    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
    e real answer.

    The behaviour of the person asking the question determines the answer they get, not wh
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ether it is the right answer or not.

    The behaviour of the Manager towards his workforce determines wh
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ether the workforce tell him the truth or not.

    The Soft Skills that enable the Manager to behave so t
    .

    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
    hat what he hears is the truth, are the key skills for a Manager.

    Juggling numbers has no value if th
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e numbers that are being juggled do not represent the system they are alleged to model.

    Peter A Hunte


    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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