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    Renaissance management is a new style of business management making its way in to
    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
    the corporate world. The idea is not wholly new as it is an amalgamation of mult
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ple references over a period of the last 20 years.

    The "Renaissance Manager" has
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    a broad base of experience, and is able to make decisions based on expertise gain
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ed in different areas of business, such as marketing, finance and strategy. At Bo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rd level, a "Renaissance Organisation" will have people with wide experience who
    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
    re able to take a much more balanced view than a group of individual specialists,
    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
    who may have no experience outside their own discipline.

    The philosophy is very
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    simple and is based on three key, but simple, strands:

    1. People Passion
    2
    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
    Plain talking
    3. Organisational awareness

    The assumptions behind the appr
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ach are drawn from many texts and references two key examples are here.

    1. Jim C
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ollins - Good to Great
    h
    tp://www.jimcollins.com

    2. Russ Ackoff
    http://www.telegraph.co.uk/mone
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    /main.jhtml?xml=/money/2007/02/08/ccbguru08.xml

    Factually the work of Renaissanc
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e Management is based on the US psychology studies that show even with the increa
    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
    ed information in our lives the human brain can only compute so much and therefor
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    needs a simple plain talking methodology. Some would argue that the generalist i
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    n business is now the new specialist as market offerings become commodities there
    .

    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
    ore it is now not possible for businesses to employ specialists in every corner.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Whatever your belief the concept is here to stay and appears to be gathering pace


    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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