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    You are the manager of a small business, a team, a department, a project or even a complete company
    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
    . And you are to hire someone new. There is this candidate, but she is your opposite in nearly ever
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ything; you favour spontaneity, she doesn’t, you take subjective decisions, she rationalizes whenev
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    r possible and where you are more extraverted, she is not.

    From portfolio management we can learn
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    to spread our investments. There are many theories about how to do this. Fewer theories exist about
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    how to balance a team. We learn about different functions, activities and processes, but less about
    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
    the way to balance these. Especially when people are involved.

    Managers of different teams, of di
    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
    ferent organizations will respond uniquely to this question. Any organization or team has its uniqu
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e characteristics, yet there are many traits that are familiar amongst all of them.

    According to y
    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
    ur personal preferences you will focus more on one style and leave other management styles intact.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    In business however, your personal style is only slightly relevant in managing teams. This counts m
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ore for larger organizations where you are chained to a large network of people. The style of the o
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ganization determines how decisions are taken. Your influence is minor.

    Still, in every team and o
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n a small scale your influence can be significant. And then you are to decide. Do I hire someone re
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    embling the rest of the team members – they all do what I say – or do we need someone to make the t
    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
    eam a bit more diverse?

    At first sight this diversity seems more difficult to manage. This is espe
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ially the case when your values, the values of the team and organization are less explicitly known.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    You will have a communication problem not only with new team members but also with third parties o
    .

    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
    others within your company.

    Diversity should come together with coherence. If you value teamwork
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    you should value diversity. This does require investment in (sound) communication.

    © 2006 Hans Boo


    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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